Support Care Cancer DOI 10.1007/s00520-015-2833-3
ORIGINAL ARTICLE
A pilot, multisite, randomized controlled trial of a self-directed coping skills training intervention for couples facing prostate cancer: accrual, retention, and data collection issues Sylvie D. Lambert 1,3 & Patrick McElduff 2 & Afaf Girgis 3 & Janelle V. Levesque 3 & Tim W. Regan 4 & Jane Turner 5 & Hayley Candler 3 & Cathrine Mihalopoulos 6 & Sophy T. F. Shih 6 & Karen Kayser 7 & Peter Chong 8
Received: 20 January 2015 / Accepted: 22 June 2015 # Springer-Verlag Berlin Heidelberg 2015
Abstract Purpose To examine the acceptability of the methods used to evaluate Coping-Together, one of the first self-directed coping skill intervention for couples facing cancer, and to collect preliminary efficacy data. Methods Forty-two couples, randomized to a minimal ethical care (MEC) condition or to Coping-Together, completed a survey at baseline and 2 months after, a cost diary, and a process evaluation phone interview. Results One hundred seventy patients were referred to the study. However, 57 couples did not meet all eligibility criteria, and 51 refused study participation. On average, two to three couples were randomized per month, and on average it took 26 days to enrol a couple in the study. Two couples withdrew from MEC, none from Coping-Together. Only 44 % of the cost diaries were completed, and 55 % of patients and 60 % of
partners found the surveys too long, and this despite the follow-up survey being five pages shorter than the baseline one. Trends in favor of Coping-Together were noted for both patients and their partners. Conclusions This study identified the challenges of conducting dyadic research, and a number of suggestions were put forward for future studies, including to question whether distress screening was necessary and what kind of control group might be more appropriate in future studies.
* Sylvie D. Lambert
[email protected]
4
Priority Research Centre for Health Behaviour, The University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia
1
Ingram School of Nursing, McGill University, Wilson Hall, 3506 University Street, Montreal, QC H3A 2A7, Canada
5
The University of Queensland, Mental Health Centre K Floor, Herston, QLD 4029, Australia
2
School of Medicine and Public Health, The University of Newcastle, HMRI Building, John Hunter Hospital Campus, New Lambton Heights, NSW 2305, Australia
6
Deakin Health Economics, Faculty of Health, Deakin University, 221 Burwood Hwy, Burwood, VIC 3125, Australia
7
3
Psycho-Oncology Research Group, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Medicine, The University of New South Wales, Locked Bag 7103, Liverpool, NSW 1871, Australia
Kent School of Social Work, University of Louisville, Louisville, KY 40292, USA
8
Lake Macquarie Urology, Level 3, Suite 2 20 Smart Street, Charlestown, NSW 2290, Australia
Keywords Coping . Pilot study . Self-care . Self-directed intervention . Caregivers . Partners Although research has traditionally focused on the negative impact of cancer on patients, it is now well-recognized that
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cancer also evokes numerous issues to be confronted, questions to be answered, and emotions to be faced for their partners [1]. Recent analyses conducted by Lambert et al. [2, 3] among a mixed group of cancer caregivers found that 35.8 % of caregivers reported clinically significant levels of anxiety 6 months post survivor diagnosis. This prevalence exceeded the anxiety rate reported by the survivors themselves [4] and the population norm [2]. Additional analyses [3] revealed that caregivers reporting anxiety or depression at 6 months continued to be anxious and depressed up to 2 years post-diagnosis. To help partners and caregivers tackle cancer challenges in a way that optimizes their and the patients’ health and functioning, much attention has been given to developing coping skills and self-management interventions to (a) address caregivers’ information needs, (b) equip them with the adaptive strategies and behaviors they need to curtail the impact of cancer on their daily lives (e.g., problem-solving), (c) strengthen the patientcaregiver relationship (e.g., communication skills training), and/or (d) connect them to other resources/services [5, 6]. A number of trials have substantiated the efficacy of these interventions in reducing caregivers’ burden and improving their ability to cope, relationship functioning, and aspects of quality of life (QOL) [5, 6]. Furthermore, studies have found that when interventions engage patients and caregivers (as a dyad), important synergies are achieved that contribute significantly to each person’s well-being outcomes [7]. Although the sizeable benefits of coping skills and selfmanagement interventions are well-documented, these are typically not part of routine cancer care. Most often, these interventions are delivered by highly trained health professionals through one-on-one sessions or workshops, which raises two major barriers. First, costs tend to be high and demand can easily exceed the availability of qualified professionals. Second, these interventions are often not accessed due to the additional demands they impose (e.g., travel) and personal preferences [8]. The challenge then is to use alternate delivery formats that provide ongoing support in a way that is cost-effective and, at the same time, offer caregivers the flexibility to choose when and where to engage in the intervention. The recent urgency to find sustainable modes to deliver coping skills and self-management interventions has contributed to an exponential increase in the evidence supporting the efficacy and cost-effectiveness of a selfdirected (or self-administered) format [9, 10]. Although self-directed interventions are promising [9, 10], most of these still do not include patients’ partners. To address this gap in the literature, our team has recently developed Coping-Together, a self-directed coping skills intervention for patients diagnosed with cancer and their partners [11]. A qualitative evaluation of Coping-Together supported its practical approach and potential to facilitate independent
coping [11]. The present pilot study builds on this study to further (a) examine the feasibility of a trial to evaluate Coping-Together among couples facing prostate cancer and (b) collect preliminary efficacy data.
Methods Design This pilot is a multicenter, stratified, double-blind, two-group, parallel, randomized controlled trial to compare CopingTogether to a minimal ethical care (control) group [12]. The design of this study was guided by the CONSORT statement [13]. The development of Coping-Together has been described elsewhere [11, 12]. Sample A convenience sample of men diagnosed with early-stage prostate cancer and their partners were invited to participate in the study by their clinicians across six recruiting sites. Patient inclusion criteria were diagnosed in the past 4 months, receiving or planning to receive treatment (including active surveillance), having no previous cancer diagnosis, and having a partner (spouse, boy/girlfriend, or de facto) willing to participate in the study. In addition, to be eligible for this study, the patient or their partner had to score four or more on the distress thermometer (DT) at the time of recruitment and both needed to be sufficiently fluent in English and cognitively able to participate in the study. Procedures Most participants were recruited through urologists’ private practices in Australia. Eligible patients were invited to meet with the on-site research assistant (RA) to further discuss study participation and obtain their DT score. If the patient scored less than four on the DT, and their partner was present, the DT was then administered to them. If the partner was not present, consent was obtained from the patient to contact them and screen for distress by phone. The RA then gave or mailed a study pack to eligible couples. If the RA was not present at the time of recruitment, the urologists gave interested patients a study pamphlet and obtained verbal consent for the RA to contact them within the following week. For these patients, all additional eligibility assessment was conducted over the phone. The study was also advertised through a range of media outlets (e.g., newspaper). Once patients’ and partners’ consent forms and baseline surveys were returned, the couple was randomized. This study was approved by the relevant ethics committees.
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Randomization and group assignment A computer-generated randomization schedule with block lengths of variable size (4 and 6) and stratified by recruitment source was accessible to the study coordinator. Couples were randomized to Coping-Together or the minimal ethical care (MEC) control condition. Intervention couples received the four Coping-Together booklets that propose specific coping strategies to address the following challenges: (a) symptom management (coping with common treatment side effects), (b) communicating effectively with health-care professionals (tips to enhancing communication with the health-care team), (c) supporting your partner (focused on enhancing the patients’ and their partners’ communication skills and tips to adjusting to changes in the relationship), and (d) managing worries and emotions (suggestions to address the emotional reactions to the diagnosis and treatment) [18]. Couples were not expected to read each booklet cover-to-cover. Rather, the couples were encouraged to review the content of the booklets and the suggested strategies together to select those that were most appropriate to address current challenges. Across the booklets, the proposed strategies were aimed at either the individuals’ coping ability (e.g., tips to deal with a symptom, relaxation strategies) or the couple’s dyadic coping skills (e.g., strategies to talk about difficult topics, conflict resolution skills, active listening strategies). The booklets were complemented by a relaxation CD and a DVD, which featured clinicians who delivered key content of the second booklet and included scenarios with couples (actors) to demonstrate specific coping skills (e.g., use of a question prompt list). One to two weeks after receiving Coping-Together, all couples participated in an orientation phone call conducted by the RA to review the material received. Couples were able to use Coping-Together at their own discretion and pace for 2 months. Couples also received, fortnightly, a ‘Top Tips’ newsletter highlighting timely content of Coping-Together and a follow-up telephone call from a RA to monitor the use of Coping-Together (Mean duration of call 1=27 min, SD= 15.35; call 2 duration=21 min, SD=12.95; call 3=16 min, SD=12.72). MEC couples were mailed the Cancer Council New South Wales Understanding Prostate Cancer and Caring for Someone with Cancer booklets and the Helpline brochure. They also received initial and follow-up phone calls comparable in intent and content to the Coping-Together couples. All phone calls were audio-recorded and reviewed to ensure that counseling was not inadvertently provided.
included to reflect all methods that would be part of a larger trial to evaluate the efficacy and cost-effectiveness of CopingTogether. However, as the present study is a pilot, the feasibility of using a cost diary is presented and discussed, but not the actual cost data. Distress screening at the time of recruitment The DT asked individuals to select a number, from 0=‘no distress’ to 10=‘extreme distress,’ that best described their overall distress in the past week [14]. A DT cutoff point of four has typically been found to result in optimal sensitivity and specificity [15]. Primary and secondary outcomes The measures used are summarized below, and further details are provided in the protocol [12]. &
& &
&
&
&
& Data collection Data collection included distress screening at recruitment, a baseline and follow-up survey, a health service-use diary, and a process evaluation interview. A health service-use diary was
Anxiety and depression were measured using the corresponding subscales on the Hospital Anxiety and Depression Scale (HADS) [16]. The Cronbach’s alpha for the HADS subscales ranges from 0.68 to 0.93 [17]. Cancer-specific distress was measured by the Impact of Event Scale-Revised (IES-R [18], α=0.78–0.96 [19]). QOL was measured with the physical and mental subscales of the Assessment of Quality of Life - 8 Dimensions (AQoL8D) [20]. Caregivers also completed the four subscales (burden, disruptiveness, positive adaptation, financial concerns) of the QOL Index-Cancer (CQOLC, α=0.91) [21]. Relationship satisfaction was measured using the Revised-Dyadic Adjustment Scale (R-DAS [22], α= 0.89–0.95 [23]), which is comprised of three subscales: consensus, satisfaction, and cohesion. Illness appraisal was measured by Kessler’s Cognitive Appraisal of Health Scale (CAHS, α>0.70) [24], Mishel’s Uncertainty in Illness Scale (MUIS, α=0.64–0.92) [25], and the Appraisal of Caregiving Scale (ACS, α>0.85) [26]. The ACS measures two types of stressful appraisals, threat and general stressfulness, and one type of positive appraisal (benefit) [26]. Self-efficacy was measured by the Lewis Cancer SelfEfficacy Scale (LCSES [27], α=0.97 [28]) and the three subscales (understand and participate in care, maintain a positive attitude, and seek and obtain information) of the Communication and Attitudinal Self-Efficacy for Cancer (CASE-Cancer, α=0.76–0.77 [29]). Individual coping strategies were assessed by the Brief COPE (α=0.60–0.90) [30]. Items were combined according to the structure proposed by Cooper et al. [31]: emotion-focused, problem-focused, and dysfunctional coping. The nine subscales of the Dyadic Coping Inventory (DCI, α=0.63–0.93) [32, 33] were used to
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measure dyadic coping: stress communication by oneself, supportive dyadic coping by oneself, delegated dyadic coping by oneself, negative dyadic coping by oneself, stress communication of the partner, supportive dyadic coping of partner, delegated dyadic coping of partner, negative dyadic coping by the partner, and common dyadic coping.
Results Sample Table 1 details participants’ demographic and treatment variables by group. Referral
Health service-use diary A BMy Cancer Care Diary^ [34] was also completed by patients and their partners, separately, to record their own costs related to (a) care from health-care professionals, (b) hospital or respite care, (c) medication use, (d) community services or pastoral care, (e) additional costs, and (f) time off from usual activities.
During the recruitment period, 170 patients were referred to the study (see Fig. 1). Of these, 57 couples did not meet all eligibility criteria, and 51 couples declined study participation. Ineligible dyads mainly had no willing partner (n=16), the patient was more than 4 months post-diagnosis (n=11), or the patient and partner scored less than four on the DT (n= 11). The top reason for refusal was not interested (n=31). As a result, 42 couples were randomized. Retention
Feasibility and acceptability of study methods Feasibility and acceptability data included response and accrual rates as well as attrition. At the end of the surveys, participants were also asked to indicate how much time it took to complete the survey, whether the survey was too long (yes/ no), and preferences for completing the survey in the future (online, pen and paper, or over the phone). Last, the process evaluation interview served as an exit interview for those couples who consented (21 patients and 17 partners) and focused on summarizing use of the resources they were randomized to as well as the acceptability of the methods.
Demographic information In addition, demographic information was collected at the time of the orientation phone call.
Data analysis Data were analyzed using Stata v13 and SAS v9.3. Means, standard deviations, and proportions were calculated to describe the sample and flow of participants. For the primary and secondary outcomes, intention-to-treat analysis was conducted separately for patients and partners. The primary outcome, anxiety at 2 months post-baseline, was analyzed using analysis of covariance (ANCOVA). The main predictor variable in the ANCOVA model was treatment group, and the participants’ baseline score was included as a covariate. ANCOVA was also used to explore the secondary outcomes. As this is a pilot study, p≤0.30 was taken to be indicative of an efficacy trend in the data.
Of the 42 couples enrolled, 32 patients and 32 partners returned a follow-up survey. Two couples withdrew from MEC (see Fig. 1), and four patients and five partners were considered lost to follow-up. No couples withdrew from Coping-Together; however, four patients and three partners were lost to follow-up. Feasibility and acceptability of data collection methods Distress screening None of the participants refused to provide a DT score. However, only one clinic had in place distress screening procedures, and having to screen for distress was a deterrent for clinicians to recruit. This led to a change in the procedures whereby the RA would screen once patients were referred to the study. The average score on the HADS-Anxiety subscale at baseline for patients was 4.9 (SD=3.6) and for partners was 6.7 (SD=4.4) (p=0.045). Surveys At baseline, patients took 98.7 min (SD=47.6 min) to complete the survey, and 55 % felt the survey was too long. Similarly, partners took an average 99.2 min to complete the survey (SD=52.8 min), with 60 % feeling the survey was too long. At follow-up, the survey was five pages shorter (from 30 to 25 pages); however, 60 % of patients and 65 % of partners still felt the survey was too long. Almost a third of participants in the process evaluation said the survey was the aspect of the study they liked least (29.7 %). In general, both patients and partners preferred to complete the survey using pen and paper
Support Care Cancer Table 1 Participant characteristics
Patients MEC (n=19)
Partners CT (n=23)
MEC (n=19)
CT (n=23)
59.4 (6.7)
60.3 (8.2)
Age, years (SD)
63.1 (5.6)
64.3 (7.7)
Length of relationship: years (SD) Relationship status Married/defacto Boyfriend/girlfriend Education Primary/secondary Trade qualification University Employment Full-time/self-employed Part-time Pensioner Volunteer/household Weekly income $300–$499 $500–$799 $800–$1000 >$1000 Prefer not to answer
33.6 (14.6)
33.7 (13.1)
17 (94 %) 1 (6 %)
23 (100 %) 0 (0 %)
7 (39 %) 5 (28 %) 6 (33 %)
3 (13 %) 12 (52 %) 8 (35 %)
10 (55 %) 3 (17 %) 5 (28 %)
11 (48 %) 8 (35 %) 4 (17 %)
8 (44 %) 1 (6 %) 9 (50 %)
9 (39 %) 3 (13 %) 10 (44 %) 1 (4 %)
2 (11 %) 1 (6 %) 9 (50 %) 6 (33 %)
5 (22 %) 3 (13 %) 10 (43 %) 5 (22 %)
1 (6 %) 5 (28 %) 2 (11 %) 10 (55 %) 0 (0 %)
3 (13 %) 5 (22 %) 11 (48 %) 4 (17 %)
Treatment Surgery Radiotherapy Hormone treatment Brachytherapy Watchful waiting or active surveillance
5 (26 %) 3 (16 %) 0 (0 %) 1 (5.3 %) 3 (16 %)
8 (35 %) 2 (8.7 %) 2 (8.7 %) 1 (4.3 %) 2 (8.7 %)
SD standard deviation, MEC minimal ethical care condition, CT Coping-Together
(87.8 % patients and 84.2 % partners) compared to other means (by phone and online). Cost diary Of the 84 cost diaries sent, 23 patient and 24 partner diaries were returned. However, 10 of these were blank (i.e., 44 % returned a completed diary). This occurred despite 83 % of participants in the process evaluation reporting that the diaries were not burdensome to complete. Orientation and follow-up phone calls Across the 164 follow-up calls, only 46 (28 %) were conducted with patients and partners together. The main reasons for not conducting these as a couple were: available at different times due to work and other commitments, not having a speaker phone, participants preferring to be interviewed separately, and patient and partner living separately. In the
process evaluation interviews, the orientation call was felt necessary by 65 % of participants. Similarly, the frequency (86 %), length (79 %), and topics (61 %) discussed were found to be acceptable.
Primary and secondary outcome data As indicated in Table 2, a number of differences at baseline between patients and partners on primary and secondary outcomes are noteworthy. For patients, results suggest that Coping-Together might improve distress (intrusion and avoidance) and contribute to potentially appraising cancer as less challenging. Although both groups reported a decrease in consensus, Coping-Together couples’ decline was smaller than MEC participants’. Some improvements in the MEC group were also noted in terms of mental quality of life, uncertainty, harm/loss appraisal, and supportive dyadic coping by oneself.
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Paents not enrolled (n=128, 75.3%) • Ineligible (n=57, 44.5%)
Paents referred to the study N=170
- No willing partner (n=16, 28.1%) - >4 months since diagnosis (n=11, 19.3%) - Distress thermometer score <4 (n=11, 19.3%) - No treatment received (n=7, 12.3%) - Prostate cancer diagnosis not confirmed (n=3, 5.2%) - Cancer not localised (n=2, 3.5%) - Not fluent in English (n=2, 3.5%) - Other (n=5, 8.8%; having alternave treatment n=1, previous cancer diagnosis n=3, passed away n=1)
Consent received=42 (uptake rate= 37.2%)
• Refused (n=51, 39.9%) -
Not interested (n=31, 60.7%) Too busy (n=9, 17.5%) Did not give reason (n=2, 3.9%) Too ill (n=1, 2.0%) Study too personal (n=1, 2.0%) Survey frustrang/too repeve/long (n=2, 3.9%) Didn’t want ca info (n = 1, 2.0%) Treatment and acon regarding prostate cancer on hold (n = 1, 2.0%) - Parcipang in another trial (n = 1, 2.0%) - Study irrelevant due to acve surveillance (n = 1, 2.0%) - Study not what thought it would be (n = 1, 2.0%)
• Non-response (n = 20, 15.6%)
Couples enrolled and randomised (N=42)
Couples randomised to Coping-Together (n=23)
Couples randomised to MEC (n=19)
Orientaon Call Completed (n= 21) Not conducted (n= 2, both conducted at the same me as follow-up #1 call)
Orientaon Call Completed (n= 17) Not conducted (n= 2, one was subsequently conducted at the me of the follow-up 1 call and the other couple withdrew)
Follow-up phone call #1 4984 Completed (n= 23 paents & 22 partners) Not conducted (n= 1 partner, away)
Follow-up phone call #1 Completed (n= 16) Not conducted (n= 2, one couple facing extreme external circumstances and the other couple withdrew)
Follow-up phone call #2 Completed (n= 23 paents & partners) Not conducted (n= 0)
Follow-up phone call #2 Completed (n= 14) Not conducted (n=3; 1 couple facing extreme external circumstances, 1 couple away, 1 couple unable to establish contact)
Follow-up phone call #3 Completed (n= 23 paents & 21 partners) Not conducted (n= 2 partners; 1 unable to establish contact and 1 unwell)
Follow-up phone call #3 Completed (n= 15) Not conducted (n=2, 1 couple facing extreme external circumstances, 1 couple unable to establish contact)
Two-month follow-up Completed (n= 19 paents & 20 partners) Not completed (n=4 paents and 3 partners unable to establish contact)
Two-month follow-up Completed (n= 13 paents & 12 partners) Not completed (n=4 paents and n= 5 partners; 3 paents/4 partners unable to establish contact, 1 couple facing new cancer diagnosis)
Final sample Paents (n = 32) Partners (n = 32) Fig. 1 Flow diagram of a participant’s involvement in the randomized pilot study of Coping-Together for couples facing prostate cancer
Support Care Cancer Table 2 Comparison of the primary and secondary outcomes between patients and their partners at baseline
Variables
Patient (n=42)
Partner (n=42)
P value
Anxiety (HADS-A)
4.9 (3.6)
6.7 (4.4)
0.0450
Depression (HADS-D)
2.1 (2.6)
3.1 (3.6)
0.1425 0.4694
Self-efficacy Self-efficacy (LCSES)
140 (21)
136 (30)
Understand and participate in care (CASE)
14.4 (1.7)
14.2 (2.6)
0.6523
Maintain a positive attitude (CASE)
14.0 (2.2)
13.2 (2.4)
0.1240
Seek and obtain information (CASE)
14.7 (1.9)
14.2 (2.6)
0.3331
Mental health
0.6 (0.2)
0.5 (0.2)
0.0183
Physical health
0.8 (0.1)
0.7 (0.2)
0.0097
Intrusion
0.6 (0.6)
0.7 (0.8)
0.3507
Avoidance
0.6 (0.7)
0.7 (0.8)
0.6195
Hyper-arousal
0.4 (0.4)
0.7 (0.9)
0.0391
Quality of life (AQoL)
Cancer-specific distress (IES-R)
Relationship satisfaction (DAS) Consensus
24.6 (3.5)
24.9 (3.8)
0.8015
Satisfaction
17.0 (1.6)
16.3 (2.0)
0.1180
Cohesion
12.2 (3.5)
12.5 (3.3)
0.6205
Stress communication by oneself
12.5 (2.9)
14.3 (3.1)
0.0083
Stress communication by partner
14.0 (2.5)
12.7 (2.8)
0.0231
Supportive dyadic coping by oneself
18.3 (3.3)
18.2 (3.5)
0.8841
Supportive dyadic coping of partner
20.0 (3.5)
18.2 (4.0)
0.0319
Delegated dyadic coping by oneself
3.7 (0.8)
3.6 (0.8)
0.4610
Delegated dyadic coping of partner
3.5 (0.8)
3.7 (0.9)
0.5061
Dyadic coping (DCI)
Negative dyadic coping by oneself
6.8 (2.9)
5.9 (2.2)
0.1333
Negative dyadic coping of partner
6.2 (2.4)
7.4 (3.1)
0.0440
17.0 (4.2)
18.0 (4.2)
0.3024
Common dyadic coping Illness appraisal Threat (CAHS)
12.2 (3.7)
11.6 (4.6)
0.5537
Challenge (CAHS)
23.5 (3.0)
19.2 (3.2)
<0.0001
Harm/loss (CAHS)
14.9 (4.8)
13.6 (4.7)
0.2179
Benign/irrelevant (CAHS)
11.4 (3.1)
8.7 (2.7)
<0.0001
Mishel’s uncertainty in illness scale (MUIS)
79.4 (14.0)
78.3 (13.0)
0.7147
Individual coping (Brief COPE) Emotion-focused
2.1 (0.5)
1.9 (0.5)
0.2260
Problem-focused
2.3 (0.8)
1.9 (0.7)
0.0092
Dysfunctional
1.3 (0.3)
1.3 (0.3)
0.6144
All differences that have a p<0.05 are bolded
For partners (see Tables 3 and 4), results suggest that Coping-Together might lower caregiver burden, general stress, and financial strain. Changes in illness and caregiving appraisal potentially in favor of Coping-Together were also noted for the benign/irrelevant and benefitfinding subscales. The Coping-Together partners also appeared to maintain their perceived level of cohesion with their partners, whereas this decreased for MEC partners. A similar pattern of findings is noted for emotion-focused coping strategies. In contrast, trends
favoring the MEC partners were noted for appraising the cancer as less challenging and using fewer dysfunctional coping strategies.
Discussion In the past 5 years, there has been considerable interest in couple-based interventions, including using a selfdirected format to increase reach and accessibility [6].
Support Care Cancer Table 3
Primary and secondary outcome across groups and time for patients Baseline
Follow-up
Mean change (SD)
MEC patient CT patient MEC patient CT patient MEC (n=19) (n=23) (n=13) (n=19)
CT
Difference (95 % CI) in means between groups at follow-up adjusted for baseline values
Anxiety (HADS-A)
5.3 (3.5)
4.6 (3.7)
4.4 (4.1)
3.2 (3.4)
−0.85 (3.65)
−0.72 (2.35)
−0.28 (−2.41 to 1.84)
Depression (HADS-D)
2.7 (2.9)
1.6 (2.3)
2.6 (3.5)
2.3 (3.2)
0.08 (3.01)
0.94 (2.04)
0.71 (−1.22 to 2.63)
2.89 (11.02) −4.41 (−14.92 to 6.10)
Self-efficacy Self-efficacy (LCSES)
139 (20)
141 (22)
145 (18)
145 (24)
7.92 (17.16)
Understand and participate in care (CASE) 14.1 (1.7)
14.7 (1.7)
14.8 (1.6)
15.0 (1.4)
0.62 (2.18)
0.11 (1.57)
0.01 (−1.07 to 1.09)
Maintain a positive attitude (CASE)
14.3 (2.1)
13.7 (2.3)
14.2 (2.6)
13.9 (2.2)
0.15 (3.02)
0.22 (1.00)
−0.04 (−1.50 to 1.41)
Seek and obtain information (CASE)
14.9 (1.6)
14.5 (2.2)
15.2 (1.5)
15.0 (1.9)
0.31 (1.55)
0.67 (1.57)
0.12 (−0.89 to 1.14)
Mental health (AQoL)
0.56 (0.16)
0.57 (0.20) 0.60 (0.22)
0.60 (0.18)
0.06 (0.10)
0.00 (0.13)
−0.05 (−0.14 to 0.04)**
Physical health (AQoL)
0.86 (0.13)
0.83 (0.14) 0.84 (0.14)
0.81 (0.13) −0.03 (0.13)
−0.04 (0.10)
−0.02 (−0.10 to 0.06)
Intrusion
0.54 (0.65)
0.61 (0.57) 0.54 (0.72)
0.31 (0.40) −0.05 (1.07)
−0.23 (0.37)
−0.22 (−0.63 to 0.18)**
Avoidance
0.63 (0.77)
0.61 (0.71) 0.65 (0.91)
0.35 (0.50)
0.11 (1.10)
−0.15 (0.51)
−0.29 (−0.78 to 0.20)**
Hyper-arousal
0.41 (0.52)
0.31 (0.38) 0.45 (0.77)
0.26 (0.37)
0.08 (0.85)
−0.06 (0.30)
−0.16 (−0.56 to 0.23)
Quality of life
Cancer-specific distress (IES-R)
Relationship satisfaction (DAS) Consensus
24.8 (3.0)
24.5 (3.9)
20.0 (2.5)
20.4 (3.6)
−5.00 (2.04)
−3.94 (2.54)
Satisfaction
16.8 (2.0)
17.1 (1.4)
17.4 (1.3)
17.1 (1.7)
0.42 (0.79)
0.11 (0.88)
−0.30 (−0.92 to 0.33)
Cohesion
13.3 (3.5)
11.2 (3.2)
13.2 (2.2)
11.7 (3.6)
0.69 (2.06)
0.68 (1.80)
−0.23 (−1.66 to 1.21) −0.73 (−2.19 to 0.72)
0.93 (−0.60 to 2.46)**
Dyadic coping (DCI) Stress communication by oneself
13.1 (2.6)
12.0 (3.2)
13.1 (1.2)
11.5 (2.7)
−0.31 (2.43)
−0.11 (2.40)
Supporting dyadic coping of partner
20.9 (2.9)
19.2 (3.9)
20.2 (2.4)
18.5 (3.8)
−1.15 (1.95)
−0.06 (2.21)
0.65 (−1.02 to 2.32)
Delegated dyadic coping of partner
3.8 (0.8)
3.3 (0.8)
6.9 (1.4)
5.8 (1.5)
3.12 (1.14)
2.78 (1.15)
−0.14 (−1.10 to 0.82)
Negative dyadic coping of partner
5.9 (2.3)
6.4 (2.6)
5.5 (1.6)
5.7 (2.4)
0.00 (2.31)
−0.78 (2.13)
−0.15 (−1.57 to 1.27)
Stress communication by partner
13.8 (2.8)
14.1 (2.2)
14.5 (1.7)
13.5 (2.6)
0.23 (2.17)
−0.26 (2.00)
−0.71 (−2.15 to 0.73)
Supportive dyadic coping by oneself
18.5 (3.5)
18.2 (3.2)
19.2 (2.9)
17.6 (3.0)
0.62 (3.31)
−0.42 (1.95)
−1.27 (−2.91 to 0.38)**
Delegated dyadic coping by oneself
3.8 (0.8)
3.6 (0.7)
7.6 (1.0)
7.4 (1.2)
3.81 (0.60)
3.89 (1.23)
0.01 (−0.76 to 0.77)
Negative dyadic coping by oneself
6.5 (2.6)
7.0 (3.1)
6.4 (2.0)
7.3 (2.6)
0.38 (3.12)
0.32 (1.86)
0.46 (−0.98 to 1.90)
17.3 (4.2)
16.9 (4.2)
17.2 (3.9)
17.0 (3.7)
−0.46 (3.67)
0.21 (3.07)
0.35 (−1.86 to 2.55)
Common dyadic coping Illness appraisal Threat (CAHS)
13.0 (3.7)
11.5 (3.6)
11.6 (3.9)
10.2 (4.3)
−2.00 (3.37)
−0.89 (3.38)
0.52 (−2.12 to 3.15)
Challenge (CAHS)
22.6 (2.7)
24.2 (3.1)
23.4 (2.8)
23.9 (3.2)
0.62 (2.10)
−0.58 (2.06)
−0.82 (−2.38 to 0.73)**
Harm/loss (CAHS)
16.2 (4.6)
13.9 (4.7)
16.6 (4.4)
15.8 (6.5)
−0.23 (4.09)
2.63 (4.68)
2.18 (−1.35 to 5.71)**
Benign/irrelevant (CAHS)
11.2 (3.4)
11.5 (3.0)
11.6 (2.9)
11.6 (3.4)
0.00 (2.58)
0.11 (2.90)
0.05 (−1.85 to 1.96)
81 (11)
78 (16)
71 (10)
75 (17)
Emotion-focused
2.1 (0.4)
2.1 (0.5)
2.1 (0.5)
2.0 (0.5)
0.03 (0.42)
−0.07 (0.38)
−0.10 (−0.37 to 0.18)
Problem-focused
2.3 (0.8)
2.4 (0.8)
2.0 (0.6)
1.9 (0.6)
−0.15 (0.50)
−0.40 (0.63)
−0.16 (−0.51 to 0.20)
Dysfunctional
1.4 (0.4)
1.3 (0.3)
1.3 (0.3)
1.3 (0.3)
0.01 (0.31)
0.03 (0.24)
0.00 (−0.19 to 0.19)
Uncertainty (MUIS)
−8.00 (13.02) −2.84 (9.65)
4.60 (−2.93 to 12.13)**
Individual coping (Brief COPE)
No symbol=p>0.30—need to insert SD standard deviation, MEC minimal ethical care condition, CT Coping-Together *p<0.05; **p≤0.30
However, the resources required to conduct dyadic research are often underestimated [35]. The current pilot identified some challenges in evaluating CopingTogether, and each is discussed in turn.
Patient refusal and ineligibility The refusal rate was slightly higher than expected (expected= 30 % [12], actual=39.9 %), but still lower than other trials
Support Care Cancer Table 4
Primary and secondary outcome across groups and time for partners Baseline
Follow-up
Mean change (SD)
MEC partner CT partner MEC partner CT partner MEC (n=19) (n=23) (n=12) (n=20)
CT
Difference (95 % CI) in means between groups at follow-up adjusted for baseline values
Anxiety (HADS-A)
8.0 (5.0)
5.7 (3.5)
4.3 (3.0)
4.5 (3.5)
−2.09 (2.39)
−1.21 (3.41)
0.62 (−1.49 to 2.73)
Depression (HADS-D)
4.7 (4.4)
1.8 (2.1)
2.1 (2.3)
2.1 (3.8)
−1.00 (2.28)
0.42 (3.15)
1.17 (−1.17 to 3.51)
Self-efficacy 127 (39)
143 (19)
141 (26)
146 (20)
3.30 (11.58)
Understand and participate in care (CASE) 13.2 (3.4)
Self-efficacy (LCSES)
15.0 (1.3)
14.6 (1.6)
14.7 (1.7)
0.18 (1.66)
3.21 (15.99) −0.05 (0.91)
2.17 (−9.25 to 13.60) −0.10 (−0.98 to 0.77)
Maintain a positive attitude (CASE)
12.7 (3.1)
13.6 (1.6)
13.8 (2.0)
13.9 (2.2)
0.36 (2.11)
0.47 (1.81)
0.03 (−1.39 to 1.45)
Seek and obtain information (CASE)
14.1 (3.0)
14.3 (2.2)
15.3 (1.2)
14.5 (2.1)
0.36 (2.11)
0.21 (2.37)
−0.58 (−1.93 to 0.78)
Mental health (AQoL)
0.43 (0.22)
0.48 (0.17)
0.53 (0.17)
0.51 (0.18)
0.07 (0.06)
0.02 (0.12)
−0.04 (−0.14 to 0.05)
Physical health (AQoL)
0.74 (0.22)
0.72 (0.22)
0.73 (0.19)
0.61 (0.25)
−0.10 (0.07)
−0.13 (0.14)
−0.04 (−0.14 to 0.07)
Burden (CQOLC)
13.6 (11.2)
10.2 (7.0)
8.7 (7.3)
5.8 (6.1)
−2.40 (2.46)
−4.55 (5.42)
−1.77 (−5.02 to 1.49)**
3.9 (6.8)
2.0 (3.0)
1.2 (2.4)
1.7 (4.5)
−0.45 (1.92)
0.06 (4.61)
0.57 (−2.40 to 3.54)
Positive adaption (CQOLC)
15.4 (6.7)
15.1 (5.2)
14.3 (6.5)
14.1 (6.3)
−0.65 (3.80)
−1.32 (4.90)
−0.76 (−4.10 to 2.58)
Financial concerns (CQOLC)
1.0 (1.8)
2.0 (3.1)
0.7 (2.3)
0.5 (1.2)
0.00 (0.89)
−0.71 (1.53)
−0.56 (−1.55 to 0.44)**
Quality of life
Disruptiveness (CQOLC)
Cancer-specific distress (IES-R) Intrusion
0.95 (1.03)
0.54 (0.47)
0.30 (0.28)
0.29 (0.28)
−0.41 (0.57)
−0.28 (0.39)
0.05 (−0.14 to 0.25)
Avoidance
1.03 (1.03)
0.44 (0.35)
0.26 (0.30)
0.29 (0.52)
−0.40 (0.52)
−0.14 (0.60)
0.08 (−0.31 to 0.46)
Hyper-arousal
0.97 (1.13)
0.43 (0.48)
0.26 (0.49)
0.23 (0.37)
−0.35 (0.31)
−0.20 (0.36)
0.07 (−0.14 to 0.28)
Relationship satisfaction (DAS) Consensus
25.8 (3.3)
24.0 (4.0)
21.3 (1.9)
19.2 (4.0)
−4.83 (3.07)
−4.47 (3.42)
−0.83 (−3.24 to 1.58)
Satisfaction
16.1 (2.6)
16.5 (1.4)
16.7 (0.9)
16.5 (2.0)
0.27 (1.79)
0.00 (1.91)
−0.32 (−1.53 to 0.89)
Cohesion
13.4 (2.5)
11.8 (3.7)
12.8 (2.8)
11.8 (3.7)
−0.64 (1.50)
0.34 (1.78)
0.86 (−0.53 to 2.26)**
Dyadic coping (DCI) Stress communication by oneself
14.3 (3.0)
14.4 (3.2)
13.2 (2.6)
14.1 (4.4)
−0.09 (2.47)
0.37 (2.85)
0.46 (−1.67 to 2.59)
Supporting dyadic coping of partner
18.2 (3.4)
18.1 (4.4)
17.2 (3.7)
17.7 (4.5)
−0.09 (2.34)
−0.47 (2.37)
−0.31 (−2.11 to 1.50)
Delegated dyadic coping of partner
3.7 (1.0)
3.6 (0.9)
3.4 (0.7)
3.6 (1.0)
−0.27 (0.85)
0.03 (0.74)
0.26 (−0.31 to 0.82)
Negative dyadic coping of partner
6.9 (2.4)
7.9 (3.5)
6.8 (2.7)
7.4 (3.7)
0.00 (2.14)
−0.16 (1.80)
−0.12 (−1.65 to 1.41)
Stress communication by partner
13.2 (3.0)
12.2 (2.7)
12.7 (1.7)
12.5 (3.7)
1.09 (1.45)
0.47 (2.14)
−0.61 (−2.12 to 0.91)
Supportive dyadic coping by oneself
18.1 (3.3)
18.3 (3.7)
19.3 (2.3)
18.3 (3.9)
0.64 (1.75)
0.53 (3.13)
−0.28 (−2.20 to 1.64)
Delegated dyadic coping by oneself
3.6 (0.8)
3.5 (0.8)
3.8 (0.7)
3.7 (0.8)
0.23 (0.65)
0.16 (0.60)
−0.09 (−0.51 to 0.34)
Negative dyadic coping by oneself
6.2 (2.6)
5.6 (1.9)
5.7 (2.0)
5.8 (1.9)
−0.09 (1.58)
0.11 (2.11)
0.25 (−1.07 to 1.56)
19.3 (3.3)
17.0 (4.5)
17.3 (3.2)
16.7 (4.9)
−1.64 (4.50)
0.21 (3.08)
0.96 (−1.83 to 3.76)
Threat (CAHS)
12.9 (5.6)
10.6 (3.5)
11.5 (4.2)
9.9 (3.2)
0.50 (4.01)
−0.37 (2.61)
−1.13 (−3.35 to 1.09)
Challenge (CAHS)
19.0 (4.1)
19.4 (2.3)
16.7 (3.3)
19.8 (3.3)
−2.00 (4.74)
0.21 (3.52)
2.94 (0.29 to 5.58)*
Harm/loss (CAHS)
14.9 (5.8)
12.6 (3.5)
13.3 (4.2)
13.2 (4.7)
0.60 (4.12)
1.11 (4.37)
0.26 (−3.16 to 3.69)
Benign/irrelevant (CAHS)
9.0 (3.4)
8.4 (2.1)
9.3 (2.4)
10.6 (2.6)
0.50 (4.30)
2.00 (2.29)
1.05 (−1.00 to 3.11)**
Uncertainty (MUIS)
78 (14)
78 (12)
71 (15)
70 (18)
Common dyadic coping Illness appraisal
−3.80 (13.31) −7.83 (13.99) −3.51 (−14.82 to 7.80)
Appraisal of caregiving (ACS) General stress
0.7 (0.7)
0.7 (0.6)
0.7 (0.7)
0.5 (0.8)
0.18 (0.93)
−0.19 (0.52)
Threat
2.5 (0.9)
2.3 (0.6)
2.2 (0.8)
2.3 (0.7)
−0.10 (0.26)
0.00 (0.46)
−0.31 (−0.83 to 0.21)** 0.10 (−0.22 to 0.41)
Benefit
3.0 (0.6)
3.0 (0.6)
3.0 (0.7)
3.3 (0.5)
−0.02 (0.46)
0.38 (0.60)
0.30 (−0.06 to 0.66)**
Emotion-focused
1.9 (0.5)
2.0 (0.5)
1.6 (0.5)
1.9 (0.5)
−0.35 (0.37)
−0.11 (0.42)
0.27 (−0.03 to 0.57)**
Problem-focused
1.8 (0.7)
2.0 (0.7)
1.5 (0.4)
1.8 (0.6)
−0.17 (0.57)
−0.29 (0.35)
0.08 (−0.23 to 0.38)
Dysfunctional
1.4 (0.3)
1.2 (0.2)
1.1 (0.2)
1.2 (0.2)
−0.19 (0.16)
−0.03 (0.18)
0.13 (−0.00 to 0.25)*
Individual coping
No symbol=p>0.30—need to insert SD standard deviation, MEC minimal ethical care condition, CT Coping-Together *p≤0.05; **p≤0.30
Support Care Cancer
with men with prostate cancer [36, 37]. However, the uptake rate of 37.2 % in this study is lower than what has been reported in a review of couple-based interventions [8]. Although the self-directed format was acceptable, the dyadic focus might have adversely impacted the level of interest. A review by Regan et al. [8] found that among couple-based interventions, uptake rates did vary according to the intervention’s focus, whereby coaching and individual-based interventions (patient and partner receive the same intervention separately) had higher uptake rates than dyadic interventions. The ineligibility rate was estimated at 60 %, which was mainly based on the expected prevalence of distress [38]. Although the actual ineligibility rate was lower, one of the main reasons for ineligibility was a patient or partner scoring less than four on the DT. The DT inclusion criterion was set because it is well-recognized that ignoring patients’ baseline distress and the potential for floor effects can undermine the efficacy of psychosocial interventions [39]. Despite screening, in our study, patients’ baseline HADS-anxiety score might still be too low to overcome any floor effect. A recent meta-analysis found that the efficacy of an intervention was zero for a baseline HADS-anxiety score of 4.20; however, significantly positive outcomes were predicted for baseline scores of 5.85 or more [40]. Hence, consideration might be given to increasing the DT cutoff score used [38]. Another suggestion is to consider level of distress in the context of need for additional services [41]. However, in a study by van Scheppingen et al. [42], including only distressed patients who also indicated a need for additional help resulted in halving the pool of eligible patients. Survey burden Although the evidence remains equivocal on whether survey length has an impact on response rate [43], the survey was nevertheless the most burdensome aspect of this study. Culling five pages from the follow-up survey did not increase acceptability. No study has documented the impact of survey length on response rate among individuals with cancer or their caregivers. However, in other contexts, studies have suggested that a 13- to 15-page survey was significantly more acceptable than a 23- to 24-page survey [44, 45]. Mond et al. [46] found no difference between an 8- and 14-page survey in terms of response. It has also been suggested that survey length is a factor when it takes more than 20 minutes to complete [47]. Cost diary Increasingly, including cost-effectiveness analyses in psychosocial research is advocated. Common self-report methods for health-care data include questionnaires or cost diaries [48]. In this pilot, a health service-use diary was used, as this method is generally reported to reduce recall bias [48], but a high proportion of missing data was noted. Among patients with
rectal cancer, van den Brink et al. [48] found that for the assessment of health-care utilization, a cost questionnaire with structured closed questions might replace a diary for recall periods up to 6 months. Conceptual and methodological questions about Coping-Together This pilot study was not powered to examine the efficacy of Coping-Together. Nevertheless, some trends in favor of the intervention were noted, particularly for partners. This is similar to a study by Northouse et al. [27] that found partners and caregivers benefited more from a dyadic intervention than patients in the outcomes of quality of life, appraisal, self-efficacy, and symptoms. The 2 months post-baseline data collection time point might have been too soon to detect the potential efficacy of an intervention that requires patients and partners to identify, learn, and apply skills on their own. One outcome that might reflect this limitation is supportive dyadic coping by oneself. Although relationship satisfaction trends were in favor of Coping-Together, MEC patients reported a slight increase in supportive dyadic coping by oneself. It can be posited that CopingTogether exposed patients to gaps in their supportive behaviors, which in turn might have negatively impacted on their frame of reference. However, with time, if dyadic coping skills are learned and applied, the intended positive impact of CopingTogether on this outcome might be noted. Another question raised by this pilot is whether choosing an attention control group was appropriate. Providing the Cancer Council booklets was in the end an intervention in and of itself, as few MEC participants received these booklets as part of ‘usual care.’ The Cancer Council booklets focus on factual information about diagnosis and treatment and might have met participants’ most proximal information needs [49], which is particularly reflected in the impact of the booklets on patients’ uncertainty. Hence, future studies might examine the impact of providing the Cancer Council booklets initially and then tailoring the content of Coping-Together to match patients’ and partners’ specific needs related to coping. Strengths and limitations Notwithstanding the exploratory nature of this pilot study, results lay some groundwork to further develop and test interventions for couples facing prostate cancer. A potential bias relating to participants who declined because their partner was not interested in the study is acknowledged. It may be the case that these couples simply did not feel they needed an intervention or conversely that these couples might have been too distressed. In addition, the sample was largely homogenous, limiting generalizability of the findings. Some scales (e.g., CAHS) were adapted for partners, and due to the small sample size, their psychometric properties cannot be tested.
Support Care Cancer
Conclusion 13.
This study reported on the feasibility of evaluating one of the first self-directed coping skills intervention for couples facing cancer. This study highlighted a number of challenges, including patient refusal and ineligibility and survey burden. Findings contribute to the growing evidence for couple-focus psychosocial interventions, and a number of suggestions have been put forward for future studies.
14.
Acknowledgments This study was funded by a Clinical Oncological Society of Australia/Sanofi Aventis Advancing the Care for Prostate Care Patients Research Grant 2010.
16.
Conflict of interest The authors declare that they have no competing interests.
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