None listed
Conditions
Brief summary
Some people have problems with a profound lack of energy (fatigue) after finishing cancer treatment known as post cancer fatigue. They also commonly have difficulties in concentration, sleep disturbance and low mood. The experts in the Lifestyle Clinic have developed an exercise and support program for people with post cancer fatigue which will now be evaluated in a trial. Who are the clinicians? The exercise physiologist helps with: - Activity pacing - helping to better manage day to day symptoms and activity levels; - Graded exercise therapy - increasing capacity for activity to improve health. The clinical psychologist helps with: - Memory, concentration and attention problems; - Sleep issues ; - Anxiety, mood and coping. What is involved? Those eligible will be randomized into either a simple education group or an intervention group. Regardless of what group you are allocated to you will be interviewed and asked to complete a series of questionnaires about your health and lifestyle at the beginning, at 12weeks and then 3 months later. Participation is free of charge. The education group will receive a booklet describing the principles of the treatment program and will meet with the clinicians to ensure they understand the plan. They will provide clear advice on how to implement these principles yourself at home over the 12 weeks. Those in the intervention group will receive this booklet but will also participate in regular sessions implementing the 12 week program. What is the 12 week intervention? The 12 week program is run by an exercise physiologist and clinical psychologist, designed to better manage your fatigue and related symptoms and to increase your day to day function. The program includes: - Assessment of symptoms and activity patterns with an exercise physiologist. - Assessment of your well-being with a clinical psychologist The treatment program is ‘home-based’ and is designed to suit your individual needs and current level of activity. This includes fortnightly consults either in the Clinic or by phone with your clinicians to review your progress. What happens after the trial if I get randomized into the education group? If the intervention proves to be effective and you were allocated to the education group you will be offered the intervention without cost to you. Who can participate? - People who have completed adjuvant treatment (chemotherapy, radiotherapy or hormonal treatment) for breast or bowel cancer, who have symptoms of unexplained fatigue reducing activity levels. - People who have finished treatment at least 3 months ago but less than 12 months ago. -Aged at least 18 years
Interventions
This randomized control trial will assign patients to receive either:
Arm 1: a simple education intervention - consisting of patient information booklet outlining the principles of the management program implemented in the CBT intervention and will meet with the clinicians (both the exercise physiologist and clinical psychologist) once, for approximately 45 mins, to further discuss the principles of the intervention.
Arm 2: a 12-week supervised, graded exercise program (GET) and cognitive beha
This randomized control trial will assign patients to receive either: Arm 1: a simple education intervention - consisting of patient information booklet outlining the principles of the management program implemented in the CBT intervention and will meet with the clinicians (both the exercise physiologist and clinical psychologist) once, for approximately 45 mins, to further discuss the principles of the intervention. Arm 2: a 12-week supervised, graded exercise program (GET) and cognitive behavioral therapy (CBT) intervention aimed at managing the fatigue state and improving functional status. The program consists of exercise / activity and psychological interventions and is conducted by trained exercise physiologists and clinical psychologists, based on consultations of 45mins each. In week 1, before commencing any exercise program the participants’ current exercise / activity capacity will be assessed by interview and by completion of a diary. The planned exercise / activity program will be tailored to the subjects’ capacity. Progress will be reviewed at weeks 2, 3, 5 and 7, either in person or by telephone, each consultation taking approximately 45mins. At the end of 12 weeks and again at 24 weeks, subjects in both arms of the study will be interviewed (for approximately one hour) and have their exercise capacity reassessed via a consultation of approximately one hour.
Sponsors
University of NSW
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
report clinically significant fatigue (i.e. ‘SOMA positive’ status on the SPHERE questionnaire); be at least 18 years of age; have completed adjuvant therapy for cancer at least three months prior; be free of co-morbid medical or psychiatric conditions which explain ongoing fatigue, or preclude participation in an exercise/activities program (e.g. organ dysfunction such as cardiac, renal or liver disease); be free of clinical or laboratory evidence of cancer recurrence; are within 12 months of finishing adjuvant therapy for either breast or colon cancer.
Exclusion criteria
they are unable to adequately speak or understand or read English; they have significant co-morbid conditions precluding participation; their primary physician declines their participation on clinical grounds; are unable to attend the face-to-face sessions of the program.
Outcome results
None listed