Introduction Many women in rural Ethiopia do not receive adjuvant therapy following breast cancer surgery despite the majority being diagnosed with estrogen-receptor-positive breast cancer and tamoxifen being available in the country. We aimed to compare a breast nurse intervention to improve adherence to tamoxifen therapy for breast cancer patients. Methods and Materials The 8 hospitals were randomized to intervention and control sites. Between February 2018 and December 2019, patients with breast cancer were recruited after their initial surgery. The primary outcome of the study was adherence to tamoxifen therapy by evaluating 12-month medication-refill data with medication possession ratio (MPR) and using a simplified medication adherence scale (SMAQ) in a subjective assessment. Results A total of 162 patients were recruited (87 intervention and 75 control). Trained nurses delivered education and provided literacy material, gave additional empathetic counselling, phone call reminders, and monitoring of medication refill at the intervention hospitals. Adherence according to MPR at 12 months was high in both the intervention (90%) and control sites (79.3%) (P = .302). The SMAQ revealed that adherence at intervention sites was 70% compared with 44.8% in the control sites (P = .036) at 12 months. Persistence to therapy was found to be 91.2% in the intervention and 77.8% in the control sites during the one-year period (P = .010). Conclusion Breast nurses can improve cost-effective endocrine therapy adherence at peripheral hospitals in low-resource settings. We recommend such task sharing to overcome the shortage of oncologists and distances to central cancer centers.
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.
BackgroundFatigue is a common symptom in breast cancer patients, and it is one of the major factors that influence the quality of life (QoL). Cognitive behavioural therapy (CBT) has been recommended to manage cancer-related fatigue. In this study, CBT will be integrated with activity pacing (AP), which can help breast cancer patients achieve a balance between activity and rest. Therefore, this pilot study aimed to investigate the acceptability, feasibility, and efficacy of the CBT-AP intervention.MethodsA total of 10 fatigued breast cancer patients undergoing chemotherapy were included in the study. The acceptability and feasibility of the study were measured by the patient recruitment rate, attrition rate, intervention fidelity, intervention compliance, and therapist’s and participant’s evaluations of the intervention. The outcomes were measured at baseline and at 6 weeks of intervention.ResultsThe pre–post study suggested that CBT-AP was found to be acceptable and feasible for fatigued breast cancer patients undergoing chemotherapy. Among 27 eligible participants, 10 (37.03%) participants accepted our invitation to participate in the study. One participant dropped out from the intervention because of serious illness, and the dropout rate was 10%.Both the intervention fidelity and intervention compliance were found to be satisfactory.Fatigue severity [Brief Fatigue Inventory (BFI)] was reduced in 77.77% of participants from baseline to 6 weeks of intervention. The global health status/QoL scale and physical, emotional, and social functioning scales were improved from baseline to 6 weeks of intervention. All symptom scales, except constipation, diarrhea, and financial difficulties, were decreased after the intervention. Depression [Public Health Questionnaire (PHQ)-9] was reduced in 55.55% of participants.ConclusionThis study suggested that CBT-AP is an acceptable, feasible, and potentially efficacious intervention to reduce fatigue and improve the QoL of breast cancer patients. The efficacy of a CBT-AP programme is going to be investigated in subsequent larger randomized clinical trials.
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