None listed
Conditions
Brief summary
The current study aims to deliver and evaluate a new telehealth, psychologist-led cancer-related fatigue ) treatment program in women with ovarian cancer, called REFRESH-Ovarian. Who is it for? You may be eligible for this study if you are an adult female with ovarian cancer who lives in a rural and remote area of Australia, and are experiencing mild-to-severe levels of cancer-related fatigue. Study details The program will screen and offer treatment to people with ovarian cancer experiencing mild-to-severe levels of cancer-related fatigue, in the form of a (i) workbook based on cognitive behavioural therapy (CBT) principles and (ii) psychologist support (e.g., phone-coaching and/or group CBT). Data on the acceptability, feasibility and appropriateness of the study will be collected. It is hoped that findings from this study will help inform future interventions for cancer-related fatigue and also address the health disparities faced by people with ovarian cancer and people living in rural and remote areas.
Interventions
The Refresh-Ovarian program is cost-free, telehealth, stratified, stepped-care cognitive behavioural therapy (CBT) for cancer-related fatigue (CRF) tailored to people with ovarian cancer. The program aims to screen and offer referral to CBT treatment.
Participants enrolled in the program will receive:
(i) the REFRESH-Ovarian CBT workbook. This workbook has been specifically designed for this study and consists of five chapters designed to be completed over five weeks, It includes short readi
The Refresh-Ovarian program is cost-free, telehealth, stratified, stepped-care cognitive behavioural therapy (CBT) for cancer-related fatigue (CRF) tailored to people with ovarian cancer. The program aims to screen and offer referral to CBT treatment. Participants enrolled in the program will receive: (i) the REFRESH-Ovarian CBT workbook. This workbook has been specifically designed for this study and consists of five chapters designed to be completed over five weeks, It includes short readings and 20 tasks based on CBT for fatigue (e.g. activity diary, pacing, relaxation practice, thinking traps). Chapter summary: (1) About cancer-related fatigue (overview of CRF, factors contributing to CRF, and ways to manage CRF) , (2) Behaviours to help fatigue (how behaviours impact fatigue, behavioural activation, physical activity and exercise, energy management, pacing, effective rest); (3) Fatigue and your feelings (how feelings, including stress and anxiety contribute to fatigue, relaxation and mindfulness skills), (4) Your thoughts about fatigue (thought-feeling connection, identifying/reframing unhelpful thoughts, self-compassion, managing worries, coping statements) , (5) Moving on (coping card summarising skills, information on how sleep, mood, pain and diet can impact fatigue, further supports and resources). (ii) psychologist support (e.g., phone-coaching or group CBT) based on a person's baseline level of CRF (i.e. mild-to-severe). There is an option to for participants who are initially recommended Step 2 to start with Step 1 if they prefer. STEP 1 – Self-Management (for mild-to moderate fatigue): 2x Coaching Calls (approx. 30mins duration, at Week 2-3, and Week 5-6) with a clinical psychologist over five weeks to provide tailored support (e.g., psychoeducation, problem-solving, goal-setting), monitor adherence (e.g., completion of relevant chapter reading and tasks), and address any concerns raised while independently completing the CBT workbook. Participants' will be rescreened for CRF at the completion of 5 weeks. STEP 2 – Group CBT (for severe fatigue) 5x Group CBT sessions with a clinical psychologist (approximately 60 minutes long, online via telehealth) over six weeks. Sessions will run weekly, with a one-week break between session 3 and session 4 to support consolidation of CBT skills. Groups will be small (around 2-6 people) to ensure each person can receive tailored support (e.g., psychoeducation, problem-solving, goal-setting). Topics covered in CBT sessions will align with booklet chapters. All participants will be rescreened for CRF after completing their initial intervention step. Those whose CRF levels remain unchanged or worsened from screening will have a treatment planning discussion of further needs and treatment options (e.g. referral to STEP 2, community support services and/or their GP for follow-up).
Sponsors
Ovarian Cancer Australia
Study design
Allocation
Non-randomised trial
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 time of recruitment • Confirmed diagnosis of ovarian cancer and being supported by Ovarian Cancer Australia • Is English speaking and able to read English (the screening measures and the intervention are only available in English for this study). • Reports mild to severe fatigue based on a series of screening questions administered via phone prior to recruitment • Phase 1 recruitment only: Residing in rural and remote areas of Australia based on residential postcodes with Modified Monash Model (MMM) 2 or above
Exclusion criteria
At clinical screening interview is identified as: • Likely experiencing a significant sleep disorder and would better benefit from usual care CBT sleep intervention (CAN-Sleep) • Experiencing psychosis, significant psychological distress or risk of suicide or self-harm • Not experiencing persistent fatigue (i.e., symptom duration too brief)
Outcome results
None listed