Plain English Summary
Background and study aims
About four-in-ten of the 1,700 women in Wales who undergo radiotherapy for curable breast cancer every year experience extreme tiredness. Patients who experience cancer-related fatigue describe great difficulty in doing their usual activities and distressing changes in how they think and feel. As fatigue at the end of radiotherapy predicts reduced quality of life, it is vital that the symptom is managed effectively. Research shows that psychological and educational support is effective at reducing cancer-related fatigue. The patient can use this support to motivate targeted behaviours that are useful for minimising fatigue. What remains unclear is the best way to deliver this support, the active ingredients of interventions aimed at changing behaviour and an understanding of why they only work for some. This study aims to test an existing behaviour change intervention that has been adapted to help women receiving radiotherapy for breast cancer self-manage their fatigue.
Who can participate?
Woman aged 16 and older who are diagnosed with breast cancer and who have cancer related fatigue.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the behavioural programme about how to motivate helpful behaviour. Those in the second group receive the Macmillan Cancer Support booklet called ‘Coping with Fatigue’. Participants are assessed to see if their symptoms have improved.
What are the possible benefits and risks of participating?
We cannot promise taking part will help participants, but the information we get from this study could help improve the recovery of future patients who have had treatment for breast cancer. The behaviours that people develop through the self-help intervention may help some women stay active and feel more in control of their lives. We do not expect there are any disadvantages or risks from participating. To minimise the potential for mixed therapeutic messages, the local psychology team will contact trial participants who have accessed psychological support or similar services outside of the study to discuss the priority of interventions. Any additional travel costs incurred from study related visits will be reimbursed.
Where is the study run from?
Velindre Cancer Centre (UK)
When is the study starting and how long is it expected to run for?
July 2016 to April 2018
Who is funding the study?
Tenovus (UK)
Who is the main contact?
1. Ms Sarah Gaze (Public)
sarahg@cardiff.ac.uk
2. Dr Nick Courtier (Scientific)
courtierN@cardiff.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Ms Sarah Gaze
ORCID ID
Contact details
13.18 Eastgate House
35-43 Newport Road
Cardiff
CF24 0AB
United Kingdom
+44 (0)29 206 88572
sarahg@cardiff.ac.uk
Type
Scientific
Additional contact
Dr Nick Courtier
ORCID ID
Contact details
13.18 Eastgate House
35-43 Newport Road
Cardiff
CF24 0AB
United Kingdom
+44 (0)29 206 87566
courtierN@cardiff.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
31419
Study information
Scientific title
ACTIVE: A randomised feasibility trial of a behavioural intervention versus information alone to reduce fatigue in women undergoing radiotherapy for early breast cancer
Acronym
ACTIVE
Study hypothesis
Feasibility trial to evaluate processes and test the acceptability of a behavioural intervention to reduce fatigue in women prescribed radical radiotherapy for early breast cancer.
Ethics approval
Wales Research Ethics Committee 3, 30/08/2016, ref: 16/WA/0205
Study design
Pragmatic non-blinded parallel-group single-centre randomised feasibility trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Fatigue related to radiotherapy treatment for early breast cancer and the primary disease
Intervention
A prediction of the risk of fatigue will be made at baseline to allocate participants into a high or low risk group. The high risk group will be eligible for the feasibility trial. Randomised allocation within the trial and retention of randomisation codes will be via a central online database (www.sealedenvelope.com). Allocation to a behavioral intervention arm will be in the ratio 2:1 using a permuted block protocol. Participant age (≤57 years and >57 years) will be a stratification variable.
20 participants will be allocated to the behavioural intervention. This comprises three 60-minute sessions per participant. The sessions will be delivered face-to-face during the first, second and third weeks of treatment. The function of the behavioural intervention is to motivate helpful behaviour change. It is informed by a CBT model of symptom management with elements of motivational interviewing (MI) incorporated. The intervention is built on four main components: education; motivation to change; goal setting and monitoring; emotional support.
Participants allocated to the control (‘education alone’) arm will be given the Macmillan Cancer Support booklet called 'Coping with Fatigue'.
Approximately 45 participants who are predicted to be at a low risk of fatigue will be eligible to be included in a fatigue risk score validation sub study group. These participants will not enter the trial part of the study, but will complete the Functional Assessment of Chronic Illness Therapy fatigue subscale (FACIT-F) on the last day of their treatment and 10 days after their radiotherapy finishes. This will be used to enable an assessment of the accuracy of the fatigue risk score prediction tool.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Fatigue, measured by the FACIT-F 10 days after the completion of radiotherapy
Secondary outcome measures
1. Anxiety, measured using the hospital anxiety and depression scale (HADS) anxiety scale at baseline and 10 days after radiotherapy
2. Physical activity, measured by the Fitbit Alta activity tracker (minutes active and asleep, daily steps taken, distance covered, calories burned if required) during radiotherapy
3. Physical functioning, measured using the European organization for research and treatment of cancer quality of life physical functioning subscale (EORTC-QLQc30 version 3.0) at baseline, end of radiotherapy and 10 days after completion of radiotherapy
4. Self-efficacy, measured using Amy Hoffman’s measure of self-efficacy for fatigue self-management, at baseline, end of radiotherapy and 10 days after completion of radiotherapy
Overall trial start date
15/07/2016
Overall trial end date
04/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Females > 16 years
2. Diagnosis of Stage 0–IIIA breast carcinoma
3. Standard 4000cGy in 15 fractions over three weeks ± nodal irradiation, ± boost
4. Able to complete outcome measures
5. Patients will be eligible if they are receiving monoclonal antibodies or endocrine treatment as maintenance therapy
6. A score of ≥ 5 on the fatigue risk score tool to enter the trial study
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
30 participants in the trial and 45 in the fatigue risk score validation sub study group
Total final enrolment
86
Participant exclusion criteria
1. Not prescribed radical radiotherapy
2. Psychiatric illness requiring secondary care intervention
3. Serious comorbidity causing chronic fatigue
4. Too ill to engage with the intervention in the opinion of the clinical care team
Recruitment start date
03/11/2016
Recruitment end date
30/09/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Velindre Cancer Centre
Velindre Road
Whitchurch
Cardiff
CF14 2TL
United Kingdom
Sponsor information
Organisation
Cardiff University
Sponsor details
Research and Innovation Servies
Governance & Contracts
Cardiff University
30-35 Newport Road
Cardiff
CF24 0DE
United Kingdom
+44 (0)29 20875834
resgov@cardiff.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Tenovus
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Plan to be developed by the rial management group, however, the aim is to publish the protocol and study results in a peer reviewed journal in late 2018.
IPD sharing statement
The datasets generated during and/or analysed during the current study will be available upon consideration by the TMG. Contact Dr Nick Courtier(courtierN@cardiff.ac.uk). The data will contain no personal identifiable information and will not be available until after publication of the main findings in a high-quality journal. Individual consent from participants was not required as confirmed by the HRA REC approval.
Intention to publish date
01/10/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29992037