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Qigong and cancer survivors - a three-armed randomized controlled study

Introduction:
For decades, Qigong, a Chinese form of exercise, has been widely acknowledged by many Asian cancer survivors as a potent health-promoting physical activity. However, there is a lack of evidence on its effectiveness. In addition, lifestyle factors including physical activity participation is now a recommended guideline in cancer survivors care plan, to optimize potential benefits in reducing cancer recurrence and mortality.

Thus, the aim of this RCT is to investigate the hypothesis that QoL in the Qigong group is better than the placebo (aerobic) or usual care group

The Null Hypothesis: there is no difference in the QOL (measured with Fact G) amongst women who participate in the 8 weeks QiGong compared to the placebo or control group.

Research Plan:
Design:
A prospective randomized controlled (3-armed), single blind study was conducted from March 2010-June 2011 at University Malaya Medical Centre (UMMC). The intervention period was over eight weeks, with measurement taken at baseline and post-intervention.

Subject:
197 participants were randomly assigned to Qigong, Placebo or Usual care (control) group.
Inclusion criteria were: a) aged between 18 to 65 years; b) be first time diagnosis of breast cancer; c) be diagnosed with early stage breast cancer (stage I-II); d) had completed primary treatment with no metastasis; e) at least one year post diagnosis.
Exclusion Criteria were: a) having medical contraindications for exercise b) having major medical condition like epilepsy, uncontrolled hypertension, or cardiovascular diseases; c) currently (already) engaging in Qigong or structured aerobic exercises; and d) engaging in more than four hours in vigorous physical activities (score high in International Physical Activity Questionnaire, IPAQ).
Sample size was calculated based on an earlier study done by Saxton [17] whereby, to obtain a between-group mean-difference of 10 units SD (standard deviation) on the FACT-G score, at least 38 participants in each group were required for 80% power and at p< 0.05.

Outcome measures:
The primary outcome is QoL as measured with FACT G FACT-G is a 27-item self-report instrument designed to measure multidimensional QoL in patients with cancer. FACT-G documented a high internal coefficient (α = 0.89) for total score and its subscale alpha coefficients ranging from 0.69- 0.82. [19] The alpha coefficient (internal consistency) for the FACT-B total score was high (α =0.90) as well. [20]

The secondary outcomes are
i) distress (measured with DASS-21) , a 21 items scale measuring depression, anxiety and stress level of the subjects. The internal consistency, estimated using Cronbach's alpha ranges from 0.82 (95% CI=0.80- 0.83) for anxiety scale to 0.88 (95% CI= 0.87- 0.89) for the depression scale and 0.90 (95% CI= 0.89-0.91) for the depression scale. The reliability for the total score was 0.93 (95% CI=0.93-0.94). [22]
ii) fatigue (measured with FACT_F). FACIT-Fatigue, a 13-item with test-retest r= 0.90 and internally consistent (α range = 0.93-0.95). [21]

Statistical Analysis:
Analysis of variance, Analysis of Covariance and Kruskal Wallis were used to examine for differences between groups of the measurements.

Results:
Ninety five participants completed the trial. Qigong group demonstrated significant marginal improvement in QoL scores compared to placebo (mean difference = 7.3 unit; p=0.036) and, compared to usual care (mean difference = 6.7 unit; p = 0.048) on Functional Assessment Cancer Therapy-Breast measure. There is no significant change in QoL scores between the placebo and usual care groups. All the three groups showed no significant differences in the fatigue scores or in the distress scores at post intervention (8-week).

Conclusion:
Cancer survivors who participated in Qigong had significantly better QoL than placebo group or control group.



Trial Registration: ACTRN12611000093987
Pub 1. The QiGong protocol The Journal of Cancer Therapy 2011

For more information on the research, Please contact:
 Dr. Loh Siew Yim

Research viewed : 3224 times (22-Nov-11)
Copyright 2011 University of Malaya.