Mobile Breast Cancer e-Support Program for Chinese Women With Breast Cancer Undergoing Chemotherapy (Part 2): Multicenter Randomized Controlled Trial

Abstract

Background: Women undergoing chemotherapy for the treatment of breast cancer have frequently reported unmet supportive care needs. Moreover, easily accessible and innovative support is lacking.

Objective: The purpose of this trial was to determine the effectiveness of an app-based breast cancer e-support program to address women's self-efficacy (primary outcome), social support, symptom distress, quality of life, anxiety, and depression. Secondary objectives included exploring the association between women's health outcomes and the breast cancer e-support usage data.

Methods: A multicenter, single-blinded, randomized controlled trial was conducted. A total of 114 women with breast cancer, who were commencing chemotherapy and were able to access internet through a mobile phone, were recruited in the clinics from 2 university-affiliated hospitals in China. Women were randomized either to the intervention group (n=57) receiving breast cancer e-support plus care as usual or the control group (n=57) receiving care as usual alone. The health care team and research assistants collecting data were blinded to the women's group allocation. Bandura's self-efficacy theory and the social exchange theory guided the development of the breast cancer e-support program, which has 4 components: (1) a Learning forum, (2) a Discussion forum, (3) an Ask-the-Expert forum, and (4) a Personal Stories forum. Moderated by an experienced health care professional, the breast cancer e-support program supported women for 12 weeks covering 4 cycles of chemotherapy. Health outcomes were self-assessed through paper questionnaires in clinics at baseline before randomization (T0), after 3 (T1), and 6 months (T2) of follow-ups.

Results: Fifty-five participants in the intervention group and 49 in the control group completed the follow-up assessments (response rate: 91.2%). During the 12-week intervention, the log-in frequency ranged from 0 to 774 times (mean 54.7; SD 131.4; median 11; interquartile range, IQR 5-27), and the total usage duration ranged from 0 to 9371 min (mean 1072.3; SD 2359.5; median 100; IQR 27-279). Repeated measures multivariate analysis of covariance (intention-to-treat) found that breast cancer e-support + care as usual participants had significant better health outcomes at 3 months regarding self-efficacy (21.05; 95% CI 1.87-40.22; P=.03; d=0.53), symptom interference (-0.73; 95% CI -1.35 to -.11; P=.02; d=-0.51), and quality of life (6.64; 95% CI 0.77-12.50; P=.03, d=0.46) but not regarding social support, symptom severity, anxiety, and depression compared with care as usual participants. These beneficial effects were not sustained at 6 months. Spearman rank-order correlation showed that the breast cancer e-support usage duration was positively correlated with self-efficacy (r=.290, P=.03), social support (r=.320, P=.02), and quality of life (r=.273, P=.04) at 3 months.

Conclusions: The breast cancer e-support program demonstrated its potential as an effective and easily accessible intervention to promote women's self-efficacy, symptom interference, and quality of life during chemotherapy.

Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616000639426; www.ANZCTR.org.au/ACTRN12616000639426.aspx (Archived by Webcite at http://www.webcitation.org/6v1n9hGZq).

Keywords: breast cancer; chemotherapy; mobile app; self-efficacy; social support.

Figure 1

Screenshots of the breast cancer e-support (BCS) program home page and the 4s forums.

Figure 2

Consolidated Standard of Reporting Trials (CONSORT) diagram of Breast Cancer e-Support program (BCS) program. HCH: Central South University affiliated Hunan Cancer Hospital; ZSH: Xiamen University affiliated Zhong Shan Hospital.

Figure 3

Mean percentage changes of health outcomes from baseline to posttests (n=114). Score at 3 months percentage change=(score at 3 months-score at baseline)/score at baseline; Score at 6 months percentage change=(score at 6 months-score at baseline)/score at baseline.