Reducing fatigue in women undergoing radiotherapy for breast cancer

ACTIVE: A randomised feasibility trial of a behavioural intervention versus information alone to reduce fatigue in women undergoing radiotherapy for early breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10303368

Enrollment

Registered

2017-09-11

Start date

2016-11-03

Completion date

Unknown

Last updated

2021-08-10

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

Conditions

Fatigue related to radiotherapy treatment for early breast cancer and the primary disease Cancer

Interventions

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 allocati

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'. Appr

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Fatigue, measured by the FACIT-F 10 days after the completion of radiotherapy	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

United Kingdom

Contacts

Public ContactSarah Gaze

sarahg@cardiff.ac.uk+44 (0)29 206 88572

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026