br Fig Flow diagram of the progress
Fig. 1. Flow diagram of the progress of intervention and control group through the phases of the randomised controlled trial.
hypothesized that participants in the NuCare group would report improvements in empowerment and quality of life, decreases in distress and avoidant coping, and increases in approach coping (i.e., seeking and using social support) – when compared to the control group.
2.1. Study design, participants, and procedures
A mixed-method study was conducted, which included a parallel group randomized controlled trial (RCT) testing the efficacy of a self-help workbook (ClinicalTrials.gov identifier: NCT01718574) and a qualitative inquiry regarding the participants experiences of the intervention (see Fig. 1). Results of the latter have been reported elsewhere . Our trial report adheres to the CONSORT 2010 Statement – Updated guidelines for reporting parallel group randomized trials . Upon ethics approval by the two participat-ing hospitals in Montreal, Canada, adult cancer patients were recruited from hospital-based psychosocial support services via email invitation, flyers, and handouts at the two cancer centers. Participants were excluded if they indicated at the time of recruitment that they were currently participating or intended to participate in a workshop covering the material of the NuCare workbook. Eligible, consenting patients were informed verbally about the study protocol, signed the consent form, completed a socio-demographic questionnaire and baseline measures (week 0), and were randomized into the INTERVENTION GROUP (IG), i.e., receiving the workbook in addition to having access to usual care, or the CONTROL GROUP (CG), i.e., receiving usual care. We used random allocation in blocks of 4, 6, and 8 with Fluxametamide in order to prevent the prediction of group allocation by project staff. A research assistant accessed www.randomization.com to create sequentially numbered, opaque, sealed envelopes containing group allocation for participants. As such, the recruiter was blinded to the allocation until they assigned the intervention to the participant. Given the nature of this psychosocial intervention, it was not possible to blind the participants or the interviewer regarding the study arm to which a participant was assigned. Participants in the intervention group received the published version of the NuCare intervention, i.e., a hard copy of the 174-page workbook Mastering the art of coping in good times and bad . The workbook emphasizes training in 7 skills: mindfulness, cognitive coping skills, relaxation techniques, goal setting, problem solving, communication, and social support. The 12 book chapters also address the link between body and stress, the importance of practice for the learning of new behavior, and what is involved in coping and a healthy life style. Participants were advised to work through approximately two chapters per week over the 6-week intervention period. Participants had no contact with the research staff during the intervention/ waiting period. Upon completion of the intervention period, a subgroup of IG participants (n = 18) was interviewed via telephone for 20–30 min regarding their experience with the workbook. Participants in the control arm received Usual Care, i.e., they had access to a variety of hospital-based as well as community resources, which include one-to-one peer counseling, self-help groups, physical activities, creative courses, and more. The comprehensive clinical care approach at the participating hospital comprises Psychosocial Oncology Pro-grams, which offers patients (limited) access to professionals in the fields of social work, psychology, psychiatry, nursing, and pastoral services. Intervention group participants had access to the same hospital-based and community resources as the control group. At post-intervention/ post waiting (week 6) and at the 1-month follow-up (week 10), participants received the paper-pencil version of the study measures via letter mail including a pre-addressed, stamped return envelope.