BREATH: Web-Based Self-Management for Psychological Adjustment After Primary Breast Cancer—Results of a Multicenter Randomized Controlled Trial

Abstract

Purpose Early breast cancer survivors (BCSs) report high unmet care needs, and easily accessible care is not routinely available for this growing population. The Breast Cancer E-Health (BREATH) trial is a Web-based self-management intervention to support the psychological adjustment of women after primary treatment, by reducing distress and improving empowerment. Patients and Methods This multicenter, randomized, controlled, parallel-group trial evaluated whether care as usual (CAU) plus BREATH is superior to CAU alone. BREATH is delivered in sixteen fully automated weekly modules covering early survivorship issues. Two to 4 months post-treatment, BCSs were randomly assigned to receive CAU + BREATH (n = 70) or CAU alone (n = 80) using a stratified block design (ratio 1:1). Primary outcomes were distress (Symptom Checklist-90) and empowerment (Cancer Empowerment Questionnaire), assessed before random assignment (baseline, T0) and after 4 (T1), 6 (T2), and 10 months (T3) of follow-up. Statistical (analysis of covariance) and clinical effects (reliable change index) were tested in an intention-to-treat analysis (T0 to T1). Follow-up effects (T0 to T3) were assessed in assessment completers. Results CAU + BREATH participants reported significantly less distress than CAU-alone participants (−7.79; 95% CI, −14.31 to −1.27; P = .02) with a small-to-medium effect size (d = 0.33), but empowerment was not affected (−1.71; 95% CI, 5.20 to −1.79; P = .34). More CAU + BREATH participants (39 of 70 [56%]; 95% CI, 44.1 to 66.8) than CAU-alone participants (32 of 80 [40%]; 95% CI, 30.0 to 51.0) showed clinically significant improvement (P = .03). This clinical effect was most prominent in low-distress BCSs. Secondary outcomes confirmed primary outcomes. There were no between-group differences in primary outcomes during follow-up. Conclusion Access to BREATH reduced distress among BCSs, but this effect was not sustained during follow-up.

Empowerment in adolescents and young adults with cancer: Relationship with health‐related quality of life

“…There was a wide range of levels of empowerment, indicating room for improvement. Empowerment levels in the current study were comparable to those in a previous study in patients with breast cancer; however, this study only included female patients who were older than patients in the current study sample 21. The results of the current study demonstrated that the most important factors associated with empowerment in AYA patients were autonomy, sex, social support and coping.…”

One way or another: The opportunities and pitfalls of self‐referral and consecutive sampling as recruitment strategies for psycho‐oncology intervention trials

“…Our BREATH RCT of a low‐intensity online CBT‐based self‐management intervention for breast cancer survivors used clinic‐based consecutive sampling 6. RCT participants were a representative clinic sample with 68% reporting low‐medium distress.…”

“…Our experience of using self‐referral recruitment in 2 RCTs8, 9 has resulted in relatively short inclusion periods, attainment of target recruitment, and high participation rates relative to our other RCTs not using self‐referral as a recruitment strategy6, 10, 11, 12 (see Table 1). This provides preliminary support for the feasibility of self‐referral in POI RCTs.…”

Uptake and adherence to an online intervention for cancer-related distress: older age is not a barrier to adherence but may be a barrier to uptake

“…While reports of online interventions for cancer report on overall uptake (e.g. [7][8][9]), little research examines characteristics that predict uptake.…”

“…Barriers to accessing therapist-based interventions include limited availability [3], travel distances [4], reluctance to disclose distress [3], and concerns about stigma [3]. In response, online self-help interventions are being increasingly explored [5][6][7][8][9].…”