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Randomized Controlled Trial
. 2015 Sep 1;33(25):2763-71.
doi: 10.1200/JCO.2013.54.9386. Epub 2015 Jul 13.

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

Sanne W van den Berg  1 , Marieke F M Gielissen  2 , José A E Custers  2 , Winette T A van der Graaf  2 , Petronella B Ottevanger  2 , Judith B Prins  2
Affiliations
Randomized Controlled Trial

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

Sanne W van den Berg et al. J Clin Oncol. .

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.

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