Can Guolin Qigong (mind-body exercise) intervention improve fatigue in cancer survivors? A randomized controlled feasibility trial

ABSTRACT: Interventions: This will be a randomized controlled trial to evaluate the feasibility and effects of a 12-week Guolin Qigong (GQ) intervention (compared to usual care) on fatigue, depression, sleep quality and diurnal cortisol slope of 60 breast, lung and colorectal cancer survivors who meet the inclusion and exclusion criteria and provide written consent. All outcomes will be assessed at Week-1 (baseline), Week-6 (mid-intervention), Week-12 (post-intervention) and Week-16 (4 weeks post- intervention). At baseline (Week-1), participants will undergo a baseline assessment of questionnaires, and provide urinary samples (for 24-hour urinary cortisol test) a day prior to enrolment date to assess urinary cortisol and complete Brief Fatigue Inventory (BFI), Pittsburgh Sleep Quality Index (PSQI) and Centre for Epidemiologic Studies Depression (CES-D). At mid-intervention (week-6) and 4 weeks after completion of intervention (Week-16) BFI, PSQI and CES-D will be collected. Post-intervention (week-12) data collection will include both the three patient reported outcomes and urinary cortisol outcome. Adherence, attendance, and any adverse event will be recorded throughout the intervention period from Week-1 to Week-12 in the practice diary by the participants randomised to GQ group. The GQ intervention will include 12 weeks of face-to-face (F2F) training class in the hospital with home practice on non-class days. There will be two F2F training classes/ week of two hours each for the first two weeks to intensify the opportunity to learn the practice well and once a week for the remaining period. The frequency of home practice will be three to four times a week over the 12-week intervention period with one and a half hours to 2 hours a day of training recommended to have efficacy. Primary outcome(s): Feasibility of GQ intervention as a composite primary outcome assessed by recruitment, retention, adherence rate and adverse events (for safety) if any, using a practice diary. However, we do not anticipate any serious adverse events based on past studies of Qigong intervention conducted to improve cancer symptoms or side effects of cancer survivors.[End of Week-12 intervention.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy

DISEASE(S): Mental Health-depression,Lung Cancer,Cancer-lung-mesothelioma,Fatigue,Depression,Physical Medicine / Rehabilitation-other Physical Medicine / Rehabilitation,Alternative And Complementary Medicine-other Alternative And Complementary Medicine,Breast Cancer,Cancer-breast,Mental Health-other Mental Health Disorders,Cancer-lung-non Small Cell,Colon Cancer,Cancer-lung-small Cell,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2754737 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR