Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001334998
Ethics application status
Approved
Date submitted
7/10/2020
Date registered
10/12/2020
Date last updated
5/10/2024
Date data sharing statement initially provided
10/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Telehealth Cancer-Related Fatigue Clinic Model for Cancer Survivors: A Pilot Randomised Controlled Trial (The T-CRF Trial)
Scientific title
A Telehealth Cancer-Related Fatigue Clinic Model for Cancer Survivors: A Pilot Randomised Controlled Trial (The T-CRF Trial)
Secondary ID [1] 302214 0
Nil
Universal Trial Number (UTN)
U1111-1257-8104
Trial acronym
T-CRF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer Related Fatigue 318910 0
Condition category
Condition code
Cancer 316889 316889 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 318506 0
Behaviour
Comparator / control treatment
Group 2. (Usual Care)
Group 2 will be offered standard follow-up care plus a written 3-page booklet on “Fatigue and Cancer” published by Cancer Council Australia. The current follow-up arrangement is a specialist-led model as determined by the treating surgeons, medical oncologist, and/or radiation oncologist. Patients from Group 2 will not be denied any usual care currently offered to patients which may include referral to PAH Physiotherapy for exercise prescription.
Control group
Active

Outcomes
Primary outcome [1] 325697 0
Patient fatigue as measured by composite Brief Fatigue Inventory (BFI) Global fatigue score
Timepoint [1] 325697 0
Measured at: baseline, 3 months, 6 months and 12 months.
Secondary outcome [1] 386474 0
Patient incidence of fatigue as measured by a single item (Y/N) on the the Brief Fatigue Inventory (BFI)
Timepoint [1] 386474 0
Measured at: baseline, 3 months, 6 months and 12 months,
Secondary outcome [2] 386475 0
Patient severity of fatigue as measured by the composite Brief Fatigue Inventory (BFI) fatigue severity score
Timepoint [2] 386475 0
Measured at: baseline, 3 months, 6 months and 12 months,
Secondary outcome [3] 386477 0
Patient fatigue interference as measured by the composite Brief Fatigue Inventory (BFI) fatigue interference score.
Timepoint [3] 386477 0
Measured at: baseline, 3 months, 6 months and 12 months,
Secondary outcome [4] 386478 0
Patient distress from symptoms as measured by the composite Memorial Symptom Assessment Scale Global Distress Index (MSAS-GDI)
Timepoint [4] 386478 0
Measured at: baseline, 3 months, 6 months and 12 months,
Secondary outcome [5] 388704 0
Patient symptom burden as measured by the composite Memorial Symptom Assessment Scale (MSAS) Total score.
Timepoint [5] 388704 0
Measured at: baseline, 3 months, 6 months and 12 months,
Secondary outcome [6] 388705 0
Patient average frequency, severity and distress associated with physical symptoms as measured by the composite Memorial Symptom Assessment Scale physical symptom subscale score (MSAS-PHYS)
Timepoint [6] 388705 0
Measured at: baseline, 3 months, 6 months and 12 months,
Secondary outcome [7] 388706 0
Patient average frequency, severity and distress associated with psychological symptoms as measured by the composite Memorial Symptom Assessment Scale psychological symptom subscale score (MSAS-PSYCH)
Timepoint [7] 388706 0
Measured at: baseline, 3 months, 6 months and 12 months,
Secondary outcome [8] 388707 0
Patient total physical activity time as measured in minutes by the composite Active Australia Survey (AAS)
Timepoint [8] 388707 0
Measured at: baseline, 3 months, 6 months and 12 months,
Secondary outcome [9] 388708 0
Patient total moderate activity time as measured as measured in minutes by the composite Active Australia Survey (AAS)
Timepoint [9] 388708 0
Measured at: baseline, 3 months, 6 months and 12 months,
Secondary outcome [10] 388709 0
Patient total vigorous activity time as measured in minutes by the composite Active Australia Survey (AAS)
Timepoint [10] 388709 0
Measured at: baseline, 3 months, 6 months and 12 months,
Secondary outcome [11] 388710 0
Patient average weekday sitting time as measured in hours by a single item from the International Physical Activity Questionnaire short-form (IPAQ-S).
Timepoint [11] 388710 0
Measured at: baseline, 3 months, 6 months and 12 months,
Secondary outcome [12] 388714 0
Patient emergency presentations (incidence and presenting issue) as recorded from electronic medical records
Timepoint [12] 388714 0
Collected retrospectively from Baseline to 12 months.
Secondary outcome [13] 388715 0
Patient hospital admissions (incidence, diagnosis, and length of stay) as recorded from electronic medical records
Timepoint [13] 388715 0
Collected retrospectively from Baseline to 12 months
Secondary outcome [14] 388716 0
Completion (Y/N) of the nurse-led clinic and percentage completion of items covered during the nurse-led clinic as measured by nurse clinic checklists
Timepoint [14] 388716 0
Measured at Nurse-led clinic 1, 2 and 3.
Secondary outcome [15] 388767 0
Patient apathy as measured by the cumulative total score of the Self-Reported Apathy Evaluation Scale AES-S.
Timepoint [15] 388767 0
Measured at: baseline, 3 months, 6 months and 12 months,
Secondary outcome [16] 388768 0
Carer incidence of fatigue as measured by a single item (Y/N) on the the Brief Fatigue Inventory (BFI)
Timepoint [16] 388768 0
Measured at: baseline, 3 months, 6 months and 12 months
Secondary outcome [17] 388769 0
Carer severity of fatigue as measured by the composite Brief Fatigue Inventory (BFI) fatigue severity score
Timepoint [17] 388769 0
Measured at: baseline, 3 months, 6 months and 12 months
Secondary outcome [18] 388770 0
Carer fatigue interference as measured by the composite Brief Fatigue Inventory (BFI) fatigue interference score.
Timepoint [18] 388770 0
Measured at: baseline, 3 months, 6 months and 12 months
Secondary outcome [19] 388771 0
Carer productivity loss measured by a composite modified version of the Institute for Medical Technology Assessment Valuation of Informal Care Questionnaire (iVICQ)
Timepoint [19] 388771 0
Measured at: baseline, 3 months, 6 months and 12 months
Secondary outcome [20] 388778 0
Number and type of referrals to allied health and community services as recorded from electronic hospital medical records, nurse record in research database and participant interviews.
Timepoint [20] 388778 0
Retrospectively from baseline to 12 months
Secondary outcome [21] 388779 0
Number of referrals to allied health and community services actioned as recorded from electronic hospital medical records, nurse record in research database and participant interviews.
Timepoint [21] 388779 0
Retrospectively from baseline to 12 months
Secondary outcome [22] 388780 0
Number of referrals to allied health and community services attended by patients as recorded from electronic hospital medical records, nurse record in research database and participant interviews.
Timepoint [22] 388780 0
Retrospectively from baseline to 12 months
Secondary outcome [23] 388781 0
Acceptability of the intervention as measured by one-off individual, semi-structured interview with patients, carers and health professionals involved in participant care
Timepoint [23] 388781 0
As measured at 48 weeks post-baseline.
Secondary outcome [24] 388787 0
Recruitment rate as recorded in research database
Timepoint [24] 388787 0
Prospectively throughout the recruitment period
Secondary outcome [25] 388788 0
Retention rates as recorded in research database
Timepoint [25] 388788 0
Prospectively from first recruit to completion of final participant.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation code will be kept in a sealed opaque envelope. Allocation will remain concealed from the research nurse and patient until after the patient is consented and baseline data collected.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation (using blocks of 4 and 8) will be conducted to assign participants to the control or intervention arms. To ensure equal distribution of patients with different levels of fatigue , patients will be stratified by fatigue severity (moderate: 4-6 on the BFI vs severe 7-10 on the BFI) and current cancer treatment (yes vs no).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The aim of this study is not hypothesis testing, the power level is therefore not a valid consideration for sample size. The sample size for this study (N=60) falls within the range of sample size recommendations for pilot studies of this nature. Our service data have indicated that we can expect >30 cancer survivors per week who would be eligible for this study.
Descriptive statistics will be used to report on feasibility and process-related elements (e.g., recruitment, intervention, retention rates) as well as clinical and resource outcomes. Preliminary effect size estimates for patient and resource use outcomes will be calculated following intention-to-treat principles using linear mixed models. Models will include group, time and their interaction and be adjusted by fatigue severity and current cancer treatment. Balance of demographic variables between the usual care and intervention group will be investigated using chi-square and t-test and will be included in the final model if found to be both significantly associated with the outcome and confounding the intervention. Assumptions of all models (normality, linearity, homoscedasticity) will be examined using the residuals of the model and will be described using mean, median, skewness, kurtosis and plots such as histograms and QQ-plots. If assumptions are violated, models will be either bootstrapped or log transformation as appropriate

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/12/2020
Actual
14/01/2021
Date of last participant enrolment
Anticipated
31/05/2021
Actual
28/06/2022
Date of last data collection
Anticipated
28/06/2023
Actual
28/06/2023
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17421 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 31149 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 306634 0
Charities/Societies/Foundations
Name [1] 306634 0
Princess Alexandra Research Foundation (PARF)
Country [1] 306634 0
Australia
Primary sponsor type
Individual
Name
Professor Raymond Chan
Address
Division of Cancer Services
Level 2
199 Ipswich Road
Princess Alexandra Hospital
Woolloongabba
QLD 4102

School of Nursing
N Block Level 3 342
Victoria Park Road
Queensland University of Technology
Kelvin Grove
QLD 4059
Country
Australia
Secondary sponsor category [1] 307472 0
None
Name [1] 307472 0
Address [1] 307472 0
Country [1] 307472 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306820 0
Metro South Human Research Ethics Commitee
Ethics committee address [1] 306820 0
Ethics committee country [1] 306820 0
Australia
Date submitted for ethics approval [1] 306820 0
29/06/2020
Approval date [1] 306820 0
09/07/2020
Ethics approval number [1] 306820 0
HREC/2020/QMS/63495

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105122 0
Prof Raymond Chan
Address 105122 0
Division of Cancer Services
Level 2
199 Ipswich Road
Princess Alexandra Hospital
Woolloongabba
QLD 4102

School of Nursing
N Block Level 3 342
Victoria Park Road
Queensland University of Technology
Kelvin Grove
QLD 4059
Country 105122 0
Australia
Phone 105122 0
+61731387311
Fax 105122 0
Email 105122 0
[email protected]
Contact person for public queries
Name 105123 0
Raymond Chan
Address 105123 0
Division of Cancer Services
Level 2
199 Ipswich Road
Princess Alexandra Hospital
Woolloongabba
QLD 4102

School of Nursing
N Block Level 3 342
Victoria Park Road
Queensland University of Technology
Kelvin Grove
QLD 4059
Country 105123 0
Australia
Phone 105123 0
+61731387311
Fax 105123 0
Email 105123 0
[email protected]
Contact person for scientific queries
Name 105124 0
Raymond Chan
Address 105124 0
Division of Cancer Services
Level 2
199 Ipswich Road
Princess Alexandra Hospital
Woolloongabba
QLD 4102

School of Nursing
N Block Level 3 342
Victoria Park Road
Queensland University of Technology
Kelvin Grove
QLD 4059
Country 105124 0
Australia
Phone 105124 0
+61731387311
Fax 105124 0
Email 105124 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.