Skip to content

A Telehealth Cancer-Related Fatigue Clinic Model for Cancer Survivors: A Pilot Randomised Controlled Trial (The T-CRF Trial)

A Telehealth Cancer-Related Fatigue Clinic Model for Cancer Survivors: A Pilot Randomised Controlled Trial (The T-CRF Trial)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001334998
Acronym
T-CRF
Enrollment
60
Registered
2020-12-10
Start date
2021-01-14
Completion date
2022-06-28
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to test the feasibility and impact of a telehealth cancer-related fatigue clinic model of care. Who is it for? You may be eligible for this study if you are aged 18 or older, you have completed your primary cancer treatment (including surgery, radiotherapy or chemotherapy) at least 6 weeks ago, or you have completed at least 3-months of maintenance treatment (ongoing cancer therapy, such as hormone therapy, immunotherapy, chemotherapy) at Princess Alexandra Hospital (PAH) Outpatient Clinics. Study details Participants in this study will be randomised by chance (like flipping a coin) into two groups. One group will receive standard follow-up care as determined by their treating cancer specialists as well as a booklet on cancer-related fatigue. The other group will undergo the telehealth fatigue clinic model of care. This involves three telehealth appointments (up to 60 minutes) with a specialist nurse at 2, 14 and 26 weeks after you have been enrolled. Participants in the second group will also be offered follow-up phone calls in between the telehealth appointments to check their progress. As part of the study all participants will answer a series of questionnaires at 3, 6 and 12 months after enrolment. It is hoped this research will demonstrate the feasibility and usefulness of the new telehealth model of care which could influence future cancer-related fatigue care.

Interventions

Group 1 (The T-CRF group) Group 1 will be offered 3 x telehealth clinics (up to one-hour each) led by a trained nurse from the Cancer Council Queensland (CCQ) at week 2, week 14 and week 26 post-baseline to: 1) conduct a cancer-related fatigue (CRF) assessment; 2) provide verbal patient education on fatigue management addressing: physical activity, current symptoms and/or general coping plus a written 3-page booklet on “Fatigue and Cancer” published by Cancer Council Australia; 3) co-develop a C

Group 1 (The T-CRF group) Group 1 will be offered 3 x telehealth clinics (up to one-hour each) led by a trained nurse from the Cancer Council Queensland (CCQ) at week 2, week 14 and week 26 post-baseline to: 1) conduct a cancer-related fatigue (CRF) assessment; 2) provide verbal patient education on fatigue management addressing: physical activity, current symptoms and/or general coping plus a written 3-page booklet on “Fatigue and Cancer” published by Cancer Council Australia; 3) co-develop a CRF Management Plan (FMP) including SMART goals (using motivational interviewing and self-efficacy techniques); and 4) facilitate referrals (including to the hospital physiotherapist), as required. Patient participants will be provided with an emailed/mailed copy of their CRF Management Plan. The CCQ nurse will action any referrals to other health professionals agreed upon during the consultation (e.g., e.g. pharmacist, dietitian, social work, physiotherapist, occupational therapist, psychologist, psychiatrist, palliative care, GP for blood tests) including one to the intervention physiotherapist, if indicated. Where referral pathways at Princess Alexandra Hospital are not available/not appropriate, participants will be referred to community organisations or to their GP to coordinate community referrals (e.g. chronic disease management plan referral to access community dietitian). CCQ nurses will also provide 10-20min follow-up phone calls to participants at three time points between the nurse led clinics (approximately once per month) to check-in with the participant and ask about their progress and offer support. Adherence to the intervention will be monitored using clinic and phone review checklists. Patients who are referred to the hospital physiotherapist will be stratified to an exercise intervention of varying exercise intensity levels and supervision based on an adapted algorithm. This framework for clinical decision making enables personalized condition assessment, risk stratification and referral to optimal settings for exercise promotion in cancer survivors. Consideration will also be given to patient preference and availability of cancer physiotherapy resources. A thorough assessment will be conducted by the intervention physiotherapist to ensure all participants are safe to exercise. All participants referred to the Physiotherapy Cancer Exercise Classes at PAH require medical clearance from treating specialists. Contraindications to the exercise class include: unstable diabetes, unstable angina, chest discomfort and shortness of breath on low activity, uncontrolled cardiac failure, severe aortic stenosis, uncontrolled hypertension (i.e. Systole > 160 and Diastole > 90 mm Hg), acute infection/fever/ feeling unwell, resting tachycardia with or without arrhythmias, and change in clinical status (e.g. symptoms occurring at lower levels of exertion or at rest). Additional contradictions to exercise relate to weight gain with signs of fluid overload, low haemoglobin, white blood cells, platelets and blood sugar, as well as low oxygen saturation. Criteria also exists for stopping exercise and when to call for rapid response. Interventions with the physiotherapist will depend on outcomes from the initial assessment (in Physiotherapy Outpatients at PAH) and patients will either attend PAH Physiotherapy exercise interventions or be referred to a community exercise program. Face-to-face (at PAH Physiotherapy Outpatients) or telehealth individual/group exercise sessions with PAH Physiotherapists will be offered over 12 weeks (once weekly) or 6 weeks (twice weekly) and may include , for example, treadmill, exercise bike, leg press, shoulder press, bicep curls or boxing depending on individual need and available equipment (if telehealth). Group exercise allows for eight participants supervised by two physiotherapists. Attendance at supervised exercise sessions or referrals to community exercise will be recorded as a measure of adherence to the intervention.

Sponsors

Professor Raymond Chan
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- At least 6-weeks after completion of their primary cancer treatment (a modality or multimodality of therapy designated to treat cancer by the oncologist/haematologist that has a definitive end point, such as surgery, radiotherapy, chemotherapy) or completed at least 3-months of maintenance treatment (ongoing cancer therapy, such as hormone therapy, immunotherapy, chemotherapy) - Receiving care at Princess Alexandra Hospital (PAH) Outpatient Clinics - Adults patients (equal to or greater than 18 years of age) - Definitive diagnosis of solid tumour or haematological cancer - equal to or greater than 4 on the global fatigue score of the Brief Fatigue Inventory (BFI) - Eastern Cooperative Oncology Group performance status of < /=2 - Not currently receiving specialist palliative care - Access to a telephone

Exclusion criteria

- Presence of severe mental, cognitive or physical conditions that would limit the patient’s ability to participate. This ensures patients have the capacity to provide informed consent, and participation in the study will not pose unethical burden on patients. - Known prognosis of <6 months at the discretion of the treating clinician. This ensures participation in this study will not pose unethical burden on patients nearing end of life. - Any other reason that deems the participant to be unsuitable to participate at the discretion of their treating clinicians/investigators. This includes any medical conditions or circumstances (e.g. active infections) where participation in this study may pose unethical burden on the patient and/or hinder their ability to provide informed consent/participate.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 12, 2026