JMIR Publications

ABSTRACT

Background:

Women with gynecological cancer receiving chemotherapy often report unmet supportive care needs. Compared with traditional face-to-face clinical interventions, mobile health (M-health) can increase access to supportive care and may address women’s needs. Although app-based support programs have been constantly developed to support women with gynecological cancers, their effectiveness has not been adequately tested.

Objective:

The aim of this study is to examine the effectiveness of a Mobile application (app) of Gynecological Cancer Support (MGCS) program for women with gynecological cancer receiving chemotherapy.

Methods:

A multi-center randomized controlled trial was conducted. A total of 168 Chinese women with gynecological cancer from two university-affiliated hospitals were recruited and randomized to receive routine care or MGCS program plus routine care for 24 weeks. Mishel’s uncertainty in illness theory guided the development of MGCS program, which has four modules: weekly topics, emotional care, discussion center, and health consultation. Uncertainty in illness (two subsales measuring ambiguity and complexity) and quality of life (four subscales measuring physical, social/family, emotional, and functional well-being) are the primary outcomes. Symptom distress and social support are secondary outcomes. All health outcomes were evaluated at baseline (T0), 12 weeks (T1), and 24 weeks (T2). Repeated-measures analysis of covariance was used to assess the effectiveness of MGCS.

Results:

Sixty-seven women in the control group and 69 in the intervention group completed two follow-up assessments (response rate: 81.0%). At 24 weeks, compared to women in the control group, women in the intervention group reported significant decreased ambiguity (P < .001; d = -0.55; adjusted mean difference = -5.10; 95% CI -7.62 to -2.57) and complexity (P = .001; d = -0.45; adjusted mean difference = -2.50; 95% CI -3.95 to -1.05) subscale scores in uncertainty in illness, and improved physical well-being (P = .027, d = 0.27; adjusted mean difference = 1.92; 95% CI 0.22 to 3.63) and emotional well-being (P = .016, d = 0.36; adjusted mean difference = 1.54; 95% CI 0.29 to 2.80) subscale scores in QoL. At 12 weeks, no significant differences existed in any health outcomes between two groups.

Conclusions:

The MGCS program demonstrated effectiveness in supporting women with gynecological cancers receiving chemotherapy. The trial illustrates how an app-based program can be incorporated into routine care to support cancer groups. This trial suggests that the allocation of greater resources to M-health in clinics is warranted. Clinical Trial: Chinese Clinical Trial Registry: ChiCTR2000033678, registered 08 June, 2020. The trial is firstly mentioned in the methods.