Condition category
Cancer
Date applied
24/08/2017
Date assigned
11/09/2017
Last edited
29/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

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 measures

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

30/04/2018

Reason abandoned

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes