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) plusBREATH 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.
RCT Entities:
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.
Authors: Karen L Syrjala; Jean C Yi; Samantha B Artherholt; Joan M Romano; Marie-Laure Crouch; Allison S Fiscalini; Mark T Hegel; Mary E D Flowers; Paul J Martin; Wendy M Leisenring Journal: J Cancer Surviv Date: 2018-05-05 Impact factor: 4.442
Authors: Lisa Beatty; Emma Kemp; Claire Binnion; Jane Turner; Donna Milne; Phyllis Butow; Sylvie Lambert; Patsy Yates; Desmond Yip; Bogda Koczwara Journal: Support Care Cancer Date: 2017-02-02 Impact factor: 3.603
Authors: N Fridriksdottir; S Gunnarsdottir; S Zoëga; B Ingadottir; E J G Hafsteinsdottir Journal: Support Care Cancer Date: 2017-09-18 Impact factor: 3.603
Authors: Joseph A Greer; Jamie Jacobs; Nicole Pensak; James J MacDonald; Charn-Xin Fuh; Giselle K Perez; Alina Ward; Colleen Tallen; Alona Muzikansky; Lara Traeger; Frank J Penedo; Areej El-Jawahri; Steven A Safren; William F Pirl; Jennifer S Temel Journal: Oncologist Date: 2019-01-25