Abstract
IMPORTANCE: Fatigue is a burdensome effect of ovarian cancer that is associated with poor sleep and quality of life. Self-acupressure is recommended in clinical guidelines but has substantial barriers to implementation. Use of a mobile app may address these barriers. OBJECTIVE: To investigate whether 6 weeks of true self-acupressure (TSA), learned via a mobile app, improves cancer fatigue, sleep, and quality of life in women with ovarian cancer compared with sham self-acupressure (SSA) and usual care (UC) and whether changes are sustained during an 18-week washout period. DESIGN, SETTING, AND PARTICIPANTS: This phase 3 single-blind randomized clinical trial was conducted from October 2019 to December 2023. Data collection ended in November 2024. Participants included ovarian cancer survivors who were fatigued (based on a Brief Fatigue Inventory [BFI] score ≥4) and who were recruited from tumor registries and social media. INTERVENTION: Randomization (1:1:1) to 6 weeks of TSA or SSA, taught via mobile app, or UC. MAIN OUTCOMES AND MEASURES: The primary outcome was the change in the BFI from baseline to week 6. Secondary analyses were the BFI score at week 24 and sleep disturbance (based on the Pittsburgh Sleep Quality Index) and quality of life (based on the Functional Assessment of Cancer Therapy-Ovarian) administered at baseline and at weeks 6, 12, and 24. RESULTS: Among the 360 participants who were screened, 171 women were randomized (mean [SD] age, 56 [12] years). Of the 160 participants who were allocated to the arms, 53 (33.1%) received TSA, 56 (35.0%) received SSA, and 51 (31.9%) received UC. Of these, the proportion achieving a clinically normal fatigue level at the end of treatment was 58.5% for the TSA arm, 51.1% for the SSA arm, and 17.6% for the UC arm. At 6 weeks, the BFI change scores were significantly better in the TSA arm but not in the SSA arm when they were compared with the UC-only arm (TSA vs UC: adjusted mean difference, -1.23 [95% CI, -2.17 to -0.29] and SSA vs UC: adjusted mean difference, -0.91 [95% CI, -1.83 to 0.02]). TSA and SSA change scores did not differ significantly from one another. The relative benefit of self-acupressure compared with UC on fatigue persisted at 24 weeks (TSA vs UC: mean difference, -1.38 [95% CI, -2.36 to -0.41] and SSA vs UC: mean difference, -0.97 [95% CI, -1.93 to -0.02]). Neither TSA nor SSA was significantly different than UC or each other for sleep quality. Only TSA significantly improved quality of life vs UC (odds ratio, 2.85 [95% CI, 1.20 to 6.80]). Neither true nor sham self-acupressure led to any adverse events. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, TSA and SSA significantly reduced fatigue compared with UC, and these changes were both clinically meaningful and sustained. No impact was observed on sleep quality. Self-acupressure, taught via a mobile app, offered a safe and low-cost option for managing cancer fatigue. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03763838.