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REFRESH: Recovery from Cancer-Related Fatigue Trial

REFRESH: Recovery from Cancer-Related Fatigue - a pilot randomised trial of an Internet-based self-management cognitive-behavioural therapy intervention to enable self-management of fatigue in post-treatment cancer survivors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN55763085
Enrollment
60
Registered
2015-10-06
Start date
2015-10-08
Completion date
Unknown
Last updated
2018-02-12

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

Conditions

Cancer-related fatigue Signs and Symptoms

Interventions

The control group will receive a PDF copy of information with brief general recommendations about fatigue management that was designed by the Irish Cancer Society. The REFRESH online intervention gro

Sponsors

National University of Ireland (Ireland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Over 18 years of age 2. Experiencing fatigue defined as scoring =4 on a unidimensional 11-point numeric rate scale for fatigue as suggested by the National Comprehensive Cancer Network (1) 3. Able to complete written records in English 4. Have or are willing to create an email account and have access to the internet 5. Have basic ability to use a computer 6. Have completed primary treatment for cancer (patients are eligible for the study if they are receiving maintenance therapy such as hormone therapies) at least 3 months prior to baseline assessment;Inclusion criteria: 1. Over 18 years of age 2. Experiencing fatigue defined as scoring =4 on a unidimensional 11-point numeric rate scale for fatigue as suggested by the National Comprehensive Cancer Network (1) 3. Able to complete written records in English 4. Have or are willing to create an email account and have access to the internet 5. Have basic ability to use a computer 6. Have completed primary treatment for cancer (patients are eligible for the study if they are receiving maintenance therapy such as hormone therapies) at least 3 months prior to baseline assessment

Exclusion criteria

Exclusion criteria: 1. Do not provide informed consent or refuse to be randomised 2. Have history of cancer recurrence 3. Do not confirm that they have received medical clearance for participation 4. Are currently participating in any other psychosocial intervention ;Exclusion criteria: 1. Do not provide informed consent or refuse to be randomised 2. Have history of cancer recurrence 3. Do not confirm that they have received medical clearance for participation 4. Are currently participating in any other psychosocial intervention

Design outcomes

Primary

MeasureTime frame
1. Feasibility and functionality outcomes will be assessed throughout the duration of the trial: 1.1. Recruitment and uptake 1.2. Adherence and attrition 1.3. Trial procedures and process analysis: functionality and usability of website 1.4. Participant satisfaction with website 2. To assess the efficacy of the “Refresh: Recovery from Cancer-Related Fatigue intervention” in long-term adult survivors of cancer, by comparing intervention and wait-list control groups: Functional impact of fatigue (primary outcome): Piper Fatigue Scale, assessed at baseline (prior to randomisation) and at 8 week follow-up;1. Feasibility and functionality outcomes will be assessed throughout the duration of the trial: 1.1. Recruitment and uptake 1.2. Adherence and attrition 1.3. Trial procedures and process analysis: functionality and usability of website 1.4. Participant satisfaction with website 2. To assess the efficacy of the “Refresh: Recovery from Cancer-Related Fatigue intervention” in long-term adult survivors of cancer, by comparing intervention and wait-list control groups: Functional impact of fatigue (primary outcome): Piper Fatigue Scale, assessed at baseline (prior to randomisation) and at 8 week follow-up

Secondary

MeasureTime frame
1. Quality of life will be assessed using the Quality of Life in Adult Cancer Survivors (QLACS) measure at baseline (prior to randomisation) and at 8 week follow-up 2. The Illness Perceptions Questionnaire for CrF will be used to assess perceptions relating to CrF Cognitive and Emotional Representations, assessed at baseline (prior to randomisation) and at 8 week follow-up 3. The Cognitive and Behavioural Responses to Symptoms Questionnaire (CBSQ) will be used to assess which cognitions and behaviours mediate the effect of cognitive behavioural therapy on fatigue, assessed at baseline (prior to randomisation) and at 8 week follow-up;1. Quality of life will be assessed using the Quality of Life in Adult Cancer Survivors (QLACS) measure at baseline (prior to randomisation) and at 8 week follow-up 2. The Illness Perceptions Questionnaire for CrF will be used to assess perceptions relating to CrF Cognitive and Emotional Representations, assessed at baseline (prior to randomisation) and at 8 week follow-up 3. The Cognitive and Behavioural Responses to Symptoms Questionnaire (CBSQ) will be used to assess which cognitions and behaviours mediate the effect of cognitive behavioural therapy on fatigue, assessed at baseline (prior to randomisation) and at 8 week follow-up

Countries

Ireland

Contacts

Public ContactTeresa;Teresa Corbett;Corbett

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Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026