Donnelly, C. M., Blaney, J. M., Lowe-Strong, A., Rankin, J. P., Campbell, A., McCrum-Gardner, E., . . . Gracey, J. H. (2011). A randomised controlled trial testing the feasibility and efficacy of a physical activity behavioural change intervention in managing fatigue with gynaecological cancer survivors. Gynecologic Oncology, 122, 618–624.
To determine the feasibility and efficacy of a physical activity (PA) behavioral change intervention on managing cancer-related fatigue among gynecological cancer survivors during and after anticancer treatments.
After telephone screening and written informed consent, blinded baseline assessments were conducted prior to randomization via a computer-generated random numbers table. Participant randomization was stratified according to treatment status (i.e., currently in treatment versus posttreatment). The intervention included an initial personal consultation with a physiotherapist who educated patients about the benefits of PA and discussed behavioral change strategies. Weekly telephone calls were used to reinforce education, identify barriers to PA, and set activity goals. A final consultation was held to establish longer-term goals and review the program. The control group also received weekly telephone calls for the duration of the intervention in order to match the attention provided to the experimental group.
The study was a two-arm, single-blind, randomized, control trial comparing a 12-week, home-based, moderate intensity, PA behavioral change intervention to a contact control (CC) group.
Four of 16 women in the PA group did not receive the intervention. The primary outcome, MFSI-SF, showed that the PA group had a significant decrease in fatigue postintervention (week 12) and at six-month follow-up compared to the CC group, with moderate to large effect sizes (d = 0.2; p = 0.001). The largest effect size on the MFSI-SF was on follow-up, suggesting that the benefits increased after completion of the 12-week intervention. No significant differences were found on any other secondary outcomes. The adjusted difference between means at follow-up for quality of life was clinically significant in favor of the PA group. No measurement tool for quality of life was specified by the authors. A mean of 10 telephone calls was made to both the PA and CC groups, with positive perception of the intervention based on exit questionnaires and focus group findings.
A PA behavioral change intervention is feasible with regard to program adherence and evaluation. The intervention may be helpful in improving fatigue.
Suggestions for further study include