This discussion of treatment fidelity will use as illustration an RCT that tested a Web-based CBSM intervention for improving coping skills in breast cancer survivors. As there existed no formalized treatment fidelity plan at the start of the RCT, this guideline is now used to guide future studies and can be used to assist others in doing so.
The Web-based CBSM intervention delivered in the RCT was based on an empirically supported in-person group treatment for psychosocial distress. It included training in cognitive behavioral therapy techniques, coping skills, social support, anger management and assertiveness, and a variety of relaxation techniques. In-person CBSM has been reported to be effective for early stage breast cancer patients, HIV-positive men and women, and prostate cancer patients (Andersen et al., 2004
; Antoni et al., 2009
; Antoni et al., 2006
; McGregor et al., 2004
). It can also be an appropriate Web-based intervention: coping skills and relaxation techniques can be taught and social support accessed, via the Internet (Cuijpers, van Straten, & Andersson, 2008
Human subjects protection review and approval was obtained from the appropriate institutional review board. Study participants were women within 18 months of a stage I–III breast cancer diagnosis who reported a moderate to severe level of distress as indicated by one of three distress measures. Participants had to have a telephone, an e-mail account, and access to a computer with an Internet connection for 2 hours a week. Study participants were recruited and self-selected primarily through the Army of Women's Website (www.armyofwomen.org
). Women volunteered to be notified about breast cancer research studies and were sent an e-mail describing the study. Interested women provided their contact information to the Army of Women, who forwarded the information to the research team. The research team called the women to provide further information about the study, answer questions, and to screen for eligibility. The women were informed that their participation was purely voluntary and they could withdraw from the study at any time without penalty. An online consent process was used.
During the 10-week experimental phase, participants randomized to the intervention group (n
= 62) used the Web-based CBSM intervention Coping with Cancer Workbook
, completing one chapter each week (see Table, Supplemental Digital Content 1
, which contains workbook content, http://links.lww.com/NRES/A62
). Besides presenting didactic information in an intuitive, easy-to-access manner, the workbook provided self-assessments with tailored feedback, interactive activities and problem-solving exercises that encouraged self-reflection, and relaxation exercises. Participants were provided with a MP3 player preloaded with the relaxation exercises so they could use them at any time. Participants were able to print a hard copy of the workbook to review or reinforce what was learned. The last chapter of the workbook provided an opportunity for the participant to set future goals related to coping with cancer. Communication among intervention participants was made possible through the workbook's discussion board feature, a social support tool that allowed participants to discuss questions related to diagnosis, treatment, and other issues relevant to women with breast cancer.
The control group participants (n = 61) were on a wait list during the 10-week experimental phase, after which they received uncontrolled access to the online workbook. Both intervention and control participants had contact with the research team by phone for screening, biweekly check-in calls during the 10-week experimental phase, and a follow-up interview.
The study's primary outcome variables were self-efficacy for coping with cancer and benefit finding (i.e., perceived benefits from the breast cancer experience such as an enhanced sense of purpose, changes in life priorities). Secondary outcome variables included impact on health-related quality of life, cancer-related intrusive thoughts, and positive mood states. Assessments of outcome variables were completed online at baseline, midstudy (week 10), and follow-up (week 20). Preliminary analysis of the first 74 women (30 intervention, 44 control) who completed the baseline and 10-week follow-up indicated that women in the intervention group reported significantly decreased depression (Center for Epidemiological Studies Depression Scale, F(2,74) = 6.3, p
= .01), confusion (Profile of Mood States confusion, F(2,74) = 6.3, p
= .01), negative mood regulation (NMR; F(2,70) = 9.01, p
= .004), and avoidance of stressful thoughts or stimuli (Impact of Event Scale, avoidance subscale, F(2,74) = 4.62, p
= .035). Intervention participants also reported significant increases in finding benefit in having had breast cancer (Benefit Finding Scale, F(2,74) = 5.6, p
= .021; Carpenter, McGregor, Schmitz & Doorenbos, 2011