ProtocolInternational Journal of Clinical Trials
Publication: Examining the effecting of a life-coaching intervention on breast cancer survivors’ post treatment adjustment: protocol of a parallel group randomized controlled trial
Int J Clin Trials. 2021;8(4):278-284.DOI10.18203/2349-3259.ijct20214035
Abstract
Background The growing number of breast cancer survivors in the country has warranted health interventions targeted to mitigate the bio-psychosocial impact associated with a cancer diagnosis and the toxicities of oncological treatments. Life coaching is a widely adopted intervention strategy to promote an individual’s positive psychological adaptation, self-management, and self-confidence. This present study will investigate whether a life coaching intervention with group and individual coaching components can significantly improve quality of life (QoL) and post traumatic growth among breast cancer survivors.
Methods This study is a randomized controlled trial with three parallel study arms. A prospective sample size of 120 adult breast cancer survivors will be randomized into one of the three study groups either to receive: 1) group coaching following by individual coaching sessions; 2) group coaching sessions only; or 3) routine care. The primary outcome evaluates post traumatic growth and secondary outcomes assess QoL and fear of cancer recurrence (FCR). Data collection will occur at baseline (T0) and at 3 weeks (T1), and at 18 weeks (T2). A follow-up assessment will occur at 30 weeks (T3).
Conclusions This is the first randomized control trial to address post traumatic growth among breast cancer survivors using a life coaching intervention. If positive, the results of this study could inform intervention development that benefits the health of cancer survivors.Trial registration: This trial is ethically approved and registered with clinical trial registry (NCT05020561).
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Affiliations
- Breast Centre, Department of Surgery, McGill University Health Centre-Montreal, QC, Canada
- Supportive and Palliative Care Programs and Services, Department of Nursing, McGill University Health Centre-Montreal, QC, Canada
- Ingram School of Nursing, Faculty of Medicine and Health Sciences, McGill University-Montreal, QC, Canada
