A study to evaluate the effect of a home-based exercise programme to manage cancer-related fatigue and improve quality of life for women recently diagnosed with gynaecological cancer

Completed

• Conditions: Gynaecological cancer; Cancer

• Registration Number: ISRCTN93279771
• Lead Sponsor: niversity of Ulster (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-25
• Last Update Posted: 30 October 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Women aged 18 years old or over
2. Recently diagnosed with stages 0 - III gynaecological cancer
3. Completed surgery and are currently receiving radiotherapy or chemotherapy or have completed anti-cancer treatment and are less than one year post anti-cancer treatment
4. Reporting mild, moderate or severe fatigue based on a numeric rating scale (where 0 = no fatigue and 10 = worst fatigue you can imagine)
5. Currently sedentary (exercising less than once a week for 20 minutes at a vigorous intensity or less than two times per week for 30 minutes at moderate intensity or less than 20 minutes three times per week, for the past six months)
6. Ambulatory and without use of a walking aid
7. Willing to be randomised

Exclusion Criteria

1. Have any medical or current psychiatric illness that could make compliance with the study protocol difficult or dangerous (e.g., unstable cardiovascular disease, hypertension, diabetes, respiratory disease, severe mental illness, cognitive dysfunction or orthopaedic problems that would limit exercise training)
2. Previously diagnosed with a fatigue-related co-morbid medical condition (fibromyalgia, chronic fatigue syndrome, multiple sclerosis (MS), myalgic encephalopathy (ME), lupus or arthritis)
3. History of cancer, i.e., not treatment naive
4. Participating in other intervention trials

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue: the Multi-dimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) and Functional Assessment of Cancer Therapy - Fatigue Subscale (FACT-F). Outcome measures will be taken at four timepoints including, baseline, 6 weeks, 12 weeks and 3 months post-intervention.

Secondary Outcome Measures

Name	Time	Method
1. Quality of life: Functional Assessment of Cancer Therapy - General (FACT-G)<br>2. Cardiorespiratory fitness: 12-minute walk test <br>3. Physical activity questionnaire: Seven- Day Physical Activity Recall (7-Day PAR) <br>4. Stage of motivational readiness for PA<br>5. Self-efficacy to exercise: Self-Efficacy Scale<br>6. Decisional balance for PA<br>7. Processes of change for PA<br>8. Mood: Positive And Negative Affects Scale (PANAS)<br>9. Sleep hygiene: Pittsburgh Sleep Disturbance Scale<br>10. Depression: Beck Depression Inventory<br>11. Functional assessment: timed sit to stand<br><br>Outcome measures will be taken at four timepoints including, baseline, 6 weeks, 12 weeks and 3 months post-intervention.