None listed
Conditions
Brief summary
Persistent cancer-related fatigue affects many cancer survivors and can have impacts on their physical, psychological and emotional wellbeing. Cognitive Behaviour Therapy (CBT) is a recommended treatment for persistent cancer fatigue in survivors. CBT focuses on changing unhelpful ways of thinking and modifying learned patterns of unhelpful behaviour, but traditional CBT programs are often provided over a long period of time (more than 6 months). This study aims to determine if a stepped-care model of behavioural care that involves patient self-management of fatigue symptoms followed by a shorter course of CBT is feasible and acceptable to cancer patients. Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed and finished treatment for any cancer type within 3 months, and you report moderate to severe fatigue based on a series of screening questions (asked prior to enrolment). Additional eligibility criteria may apply to patients with melanoma and/or blood cancers, we recommend you contact the Public queries person listed below to see if you are eligible for this study. Study details All participants who choose to enrol in this study will be given a self-management cognitive behaviour therapy (CBT) work booklet that contains activities and educational materials (Step 1). Participants will be asked to work through the booklet at their own pace over a 5 week period, and will have access to telephone and email support after the first week. Participants who do not have any change in their fatigue levels after completing this 5-week program will then be offered Step 2, which involves an additional 4 x 50 minute face-to-face/Telehealth individual or group CBT sessions with a Clinical Psychologist. It is hoped this research will determine whether it is possible and acceptable to cancer patients to deliver behavioural therapy in a stepped-care manner rather than a standard 12-week program. If this stepped-care model is acceptable to patients, it may be delivered as part of a larger trial that could help future cancer patients with their fatigue as well.
Interventions
Stepped-care cognitive behaviour therapy (CBT) for cancer survivors with persistent fatigue.
STEP 1: Participants who are experiencing moderate to severe fatigue are provided with a self-management CBT booklet to assist them with managing symptoms of fatigue and increasing energy. The booklet was designed specifically for this study and includes 17 tasks e.g. activity diary, fatigue diary, relaxation practice, thinking traps. Participants work through the booklet independently for 5 weeks, for 1
Stepped-care cognitive behaviour therapy (CBT) for cancer survivors with persistent fatigue. STEP 1: Participants who are experiencing moderate to severe fatigue are provided with a self-management CBT booklet to assist them with managing symptoms of fatigue and increasing energy. The booklet was designed specifically for this study and includes 17 tasks e.g. activity diary, fatigue diary, relaxation practice, thinking traps. Participants work through the booklet independently for 5 weeks, for 15-20 minutes a day. Telephone support from a Psychologist for 10-15 mins at weeks 2 and 5 and email support (psychologist) at weeks 1, 3 and 4 will be provided to support and monitor adherence, and to address any concerns raised. At the completion of 5 weeks, participants’ fatigue symptoms and adherence to the program will be reassessed. Those whose fatigue level does not improve significantly are referred to STEP 2. STEP 2: 4 x 50 minute face-to-face/Telehealth individual or group CBT sessions with a Clinical Psychologist will be offered commencing within 4 weeks of completing STEP 1, depending on group and participant availability. Sessions will occur weekly with up to 4 participants. Topics covered in CBT sessions will align with booklet chapters: Fatigue and your feelings, Behaviours to help fatigue, Your thoughts about fatigue, Moving on. Activities include relaxation, group discussion and worksheets. Adherence will be monitored using attendance records.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged 18 years or older at the time of recruitment • Reports moderate to severe fatigue based on a series of screening questions administered on the phone prior to recruitment • Is English speaking and able to read English (the intervention is only available in English) • Cancer criteria: EITHER i. Completed primary treatment for any cancer at least 3 months prior (to allow natural recovery) OR ii. Diagnosed with stage III or stage IV melanoma AND • is receiving maintenance treatment using a single-agent immune checkpoint inhibitor (immunotherapy) or targeted therapy AND • has an objective partial or complete tumour response by computed-tomography based imaging, or partial or complete metabolic response by positron emission tomography for a duration greater than 3 months OR iii. Diagnosed with a haematological cancer AND • a partial or complete response as demonstrated by routine response assessment (ie Imaging or pathology) after at least 3 months treatment with long term therapy OR • have previously demonstrated partial or complete response by routine response assessment post intensive treatment and have completed at least 3 months of maintenance therapy or observation OR • has not received treatment for a chronic blood cancer due to being below treatment threshold (e.g. indolent disease)
Exclusion criteria
• Insufficient English • At clinical screening interview is identified as o likely experiencing a significant sleep disorder and would better benefit from our usual care CBT sleep intervention (CAN-Sleep) and/or o experiencing psychosis, significant psychological distress or risk of suicide or self-harm o not been experiencing persistent fatigue (i.e., symptom duration too brief)
Outcome results
None listed