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Qigong Mind-Body Exercise as a Biopsychosocial Therapy for Persistent Post-Surgical Pain in Breast Cancer: A Pilot Study.

ABSTRACT: Purpose: To assess the feasibility, safety, and preliminary effectiveness of a 12-week multimodal Qigong Mind-Body Exercise (QMBE) program for breast cancer survivors with persistent post-surgical pain (PPSP). Methods: This was a single-arm mixed-methods pilot study. Primary outcome measures were feasibility (recruitment, adherence) and safety. Validated self-report questionnaires were used to evaluate a constellation of interdependent symptoms, including pain, fatigue, mood, exercise, interoceptive awareness, and health-related quality of life at baseline and 12 weeks. A subset of the instruments was administered 6 months postintervention. Shoulder range of motion and grip strength were objectively assessed at baseline and 12 weeks. Qualitative interviews were conducted at baseline and 12 weeks. Results: Twenty-one participants were enrolled; 18 and 17 participants, respectively, completed the 12-week and 6-month outcome assessment. No serious adverse events were reported. Statistically significant improvements were observed at 12 weeks in pain severity and interference, fatigue, anxiety, depression, perceived stress, self-esteem, pain catastrophizing, and several subdomains of quality of life, interoceptive awareness, and shoulder range of motion. Changes in pain, fatigue, pain catastrophizing, anxiety, depression, and quality of life were clinically meaningful. Postintervention effects were sustained at 6 months. Conclusions: QMBE is a safe and gentle multimodal intervention that shows promise in conferring a broad range of psychosocial and physical benefits for breast cancer survivors with PPSP. Results support the value of future studies evaluating the impact of QMBE on multiple outcomes relevant to breast cancer survivors with PPSP.

SUBMITTER: Osypiuk K

PROVIDER: S-EPMC7050958 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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

Project description:The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes.In this trial, we will randomize 397 adults with nonspecific chronic back pain to CBT, MBSR or usual care arms (99 per group). Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice. The MBSR protocol also includes an optional 6-hour retreat. Interviewers masked to treatment assignments will assess outcomes 5, 10, 26 and 52 weeks postrandomization. The primary outcomes will be pain-related functional limitations (based on the Roland Disability Questionnaire) and symptom bothersomeness (rated on a 0 to 10 numerical rating scale) at 26 weeks.If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain.Clinicaltrials.gov Identifier: NCT01467843.

Project description:Background: Although traditional Chinese Yijinjing Qigong Exercise (YJJQE) is popularly used in China, to alleviate symptoms of people with knee osteoarthritis (KOA), no randomized controlled trials (RCTs) are available to evaluate the effects of YJJQE in patients with KOA. The purpose of this trial is to assess the clinical efficacy of YJJQE for patients with KOA. Methods: A total of 50 participants clinically diagnosed with KOA are randomly (1:1) assigned to the YJJQE group (n = 25) and to the stretching training exercise (STE) group (n = 25), for a 40-min exercise session twice a week for 12 weeks. All outcome measures are collected at baseline and at 12-week ending intervention, which includes the primary outcomes of Western Ontario and McMaster Universities Osteoarthritis Index Scale (WOMAC), the secondary outcomes of visual analog scale (VAS), mental component summary (MCS), physical component summary (PCS), Beck depression inventory (BDI), perceived stress scale (PSS), Berg balance scale (BBS), and the Gait functional mobility data. Results: The YJJQE group did not have any significant changes compared to the control group on the WOMAC score after the 12-week intervention (P > 0.05), though the YJJQE group demonstrated better performance in MCS, BDI, and PSS (P = 0.002, P = 0.001, and P = 0.026, respectively) than the control group. No serious adverse events occurred in either group, and only mild muscle soreness was reported during both exercise treatments. Conclusion: Because no difference between both groups was shown, with regards to the primary outcome measurement (WOMAC), it can hardly explain that the YJJQE had an advantageous effect on patients experiencing the pain and dysfunction of knee osteoarthritis. However, compared to the control group, YJJQE appeared to be associated with improvements in psychological well-being including reduced stress, anxiety, depression, and mood disturbance to manage KOA. Further trials with larger sample sizes and follow-up studies will be required. Clinical Trial Registration: https://www.chictr.org.cn/edit.aspx?pid=60357&htm=4, ChiCTR2000037256.

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Qigong Mind-Body Exercise as a Biopsychosocial Therapy for Persistent Post-Surgical Pain in Breast Cancer: A Pilot Study.

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