Effects of a nurse-led yoga program on cancer-related fatigue, psychological distress, and health-related quality of life among women with gynecological cancer: A single-blind randomized controlled trial.

[BACKGROUND] Cancer-related fatigue and psychological distress are highly prevalent and impose a substantial burden on women with gynecological cancer receiving chemotherapy or chemoradiotherapy, yet they are often undertreated. Yoga, as a holistic intervention, has shown promise in alleviating these burdens and enhancing health-related quality of life among patients with breast cancer. However, evidence supporting its effectiveness in women with gynecological cancer remains limited.

[OBJECTIVE] To evaluate the effects of a nurse-led yoga program, compared with usual care, on cancer-related fatigue, psychological distress, and health-related quality of life among women with gynecological cancer undergoing chemotherapy or chemoradiotherapy.

[DESIGN] An assessor-blinded, two-arm randomized controlled trial with a 1:1 parallel-group design.

[SETTING AND PARTICIPANTS] Women with gynecological cancer receiving chemotherapy or chemoradiotherapy were recruited from a tertiary cancer hospital in Jinan, China.

[METHODS] Participants were randomly assigned to receive either a 6-week nurse-led yoga program plus usual care (intervention group) or usual care alone (control group). The primary outcome was cancer-related fatigue, and the secondary outcomes were psychological distress (distress, anxiety, and depressive symptoms) and health-related quality of life. Outcomes were assessed at baseline (T0), immediately after the 6-week intervention (T1), and 1 month after the 6-week intervention (T2). The effects of the intervention were analyzed using generalized estimating equations models.

[RESULTS] Participants in the intervention group reported significantly greater reductions in cancer-related fatigue (T1: β: -0.92, 95% CI: -1.50, -0.35, p = 0.002; T2: β: -0.71, 95% CI: -1.40, -0.03, p = 0.042) and distress (T1: β: -1.20, 95% CI: -2.05, -0.34, p = 0.006; T2: β: -1.19, 95% CI: -2.23, -0.16, p = 0.024) compared with the control group at T1 and T2. Despite no significant between-group differences being observed in overall health-related quality of life, significant improvements were noted in the subscales of physical well-being at T1 (β: 1.89, 95% CI: 0.31, 3.47, p = 0.019) and functional well-being at T2 (β: 2.67, 95% CI: 0.34, 5.00, p = 0.025) in the intervention group relative to the control group.

[CONCLUSIONS] The nurse-led yoga program was effective in alleviating cancer-related fatigue and distress in women with gynecological cancer undergoing chemotherapy or chemoradiotherapy. Yoga may be considered a part of routine care for this population where resources permit.

[REGISTRATION] Chinese Clinical Trial Registry (ChiCTR2400083352, registration date: 22/04/2024, first recruitment: 29/04/2024).