Study Protocol of CBT-AP Trial: A Randomized Controlled Trial of Cognitive Behavioral Therapy Integrated with Activity Pacing for Fatigued Breast Cancer Patients Undergoing Chemotherapy

PURPOSE: This paper reports the methodology for undertaking a randomized controlled trial to assess the combined effect of cognitive behavioral therapy (CBT) and activity pacing on fatigue experienced by breast cancer patients undergoing chemotherapy. METHOD: Fifty-eight patients experiencing severe fatigue will be randomized to a CBT group or usual care group. The intervention will be given for 6 sessions by a trained oncology nurse. Primary and secondary outcome measures will be assessed at baseline, the sixth week of intervention and at the third month post intervention. The primary outcome measure is fatigue (Brief Fatigue Inventory) and secondary outcome measures include depression (Patient Health Questionnaire) and quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire). The protocol is designed using the SPIRIT guidelines which is one of the EQUATOR checklists. DISCUSSION: This is the first RCT that will determine the efficacy of CBT by integrating with activity pacing to reduce fatigue among breast cancer patients receiving chemotherapy. The intervention design is novel in addressing multiple precipitating and perpetuating factors of fatigue and integrated with activity pacing in CBT. CONCLUSION: If the intervention is effective, this therapeutic approach can be incorporated into a routine health care for breast cancer patients receiving chemotherapy. TRIAL REGISTRATION: The study have been registered in Pan-African Clinical Trial Registry (website) on August 24, 2020. The trial registration number is PACTR202008881026130.