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.

• In total, 33 participants (100% female) were included.    
• Age was 18 years or older.
• Participants had ovarian (n = 12) and endometrial (n = 11) tumors, and the remaining participants (n = 10) had uterine, cervical, and mixed gynecological tumors. Participants were diagnosed with gynecological cancer stage I to III, had completed surgery, and were currently undergoing treatment or were postanticancer treatment within three years of diagnosis (average of nine months postdiagnosis).
• Interested participants were screened for eligibility via the telephone.
• Participants reported mild to moderate fatigue (1–10 numeric rating scale) and were currently sedentary (vigorous PA less than 20 minutes/week or moderate PA less than 60 minutes/week, for the past six months).

• Single site  
• Northern Ireland regional Cancer Centre

• Patients were undergoing multiple phases of care.
• The study has clinical applicability for late effects and survivorship.

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.

• Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)
• Functional Assessment in Chronic Illness Therapy-Fatigue (FACIT-F) subscale
• Functional Assessment of Cancer Therapy-General (FACT-G) scale
• Beck Depression Inventory II (BDI-II)
• Positive and Negative Affect Schedule (PANAS)
• Body mass index (BMI)
• Waist circumference
• 12-minute Walk Test
• Pittsburg Sleep Quality Index (PSQI)
• Self-reported Seven-Day Physical Activity Recall

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.

• The study had a small sample size.
• The study lacked statistical power.
• The results were not generalizable.
• No standardized objective measure of PA was used.
• The high rate of ineligibility among women screened limited the sample size.
• There was a 25% drop-out rate for participants assigned to intervention group.
   

Suggestions for further study include

• Larger randomized, controlled trials to confirm the effects of the PA behavioral change intervention on fatigue
• Follow-up beyond six months
• The high rate of ineligibility suggests a need to investigate interventions for those ineligible due to comorbidities and advanced disease; one might question if an activity intervention in these subgroups would be advisable and if one would see a difference in participation/adherence to the program and similar benefits to the participants in this intervention group.
• Stratification according to tumor type may reveal differences between and among groups. 
• Encouraging  findings, both quantitative and qualitative, for eligible participants suggests efficacy and implies a need for testing in a larger multicenter study. The question remains as to whether time may be all that is necessary to modify cancer-related fatigue in this population.