Condition category
Cancer
Date applied
24/05/2017
Date assigned
08/06/2017
Last edited
08/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cancer related fatigue (CRF) is a debilitating side effect reported among cancer survivors, often lasting years following treatment, causing them to experience low energy and tiredness. There is some evidence of a small to moderate effect of exercise training on fatigue, however these studies have typically been undertaken in mixed populations, including those with and without documented fatigue. In addition, there is often a lack of a proper comparison condition to provide a matched degree of group support and investigator attention. The aim of overall purpose of this study is to develop and evaluate a sustainable semi-supervised exercise training programme to reduce cancer-related fatigue in survivors with fatigue and compare changes to those of a health education comparison group.

Who can participate?
Adults aged 18 and older who are either breast, colorectal or prostate cancer survivors with ongoing fatigue.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group undertake two one hour sessions of exercise weekly for five weeks and then one session of exercise for the next five weeks. The exercise bouts are both gentle and short to begin with participants are assisted in gradually increasing exercise intensity and duration as the ten weeks progress. The programme combines both group-based and home-based exercise. Participants are free to bring an exercise buddy with them to all classes. Those in the second group meet once per week for ten weeks for one hour sessions that focus on strategies other than exercise to manage fatigue, such as food and nutrition, cognitive behaviour therapy (a type of talking therapy) and sleep management. After this, those in the education group receive the exercise programme as well. Participants fill out questionnaires before and after the 10 week programme period to assess fatigue, fear of exercise, quality of sleep and quality of life. Their fitness and the stiffness of their arteries (measure of their heart health) are also measured. Blood and saliva samples are taken to measure markers that are believed to influence fatigue. Participants are followed up again six months after the programmes are finished to assess their quality of life, fatigue, exercise, physical fitness, arterial stiffness and markers in the blood.

What are the possible benefits and risks of participating?
Participants may benefit from the health education they receive free of charge, and from receiving a copy of their personal results including changes in your fatigue and fitness profile upon request. Participants may benefit from being part of a network of individuals with similar health issues and they may find the peer support beneficial. There are risks involved with exercising, such as risks of heart problems, loss of sensation in feet, hot flushes, suppressed immune systems and lymphedema (swelling in the arms and legs). Participants may also experience extra fatigue on exercise days. Participants may experience discomfort while providing blood samples.

Where is the study run from?
1. University Hospital Waterford (Ireland)
2. Solas Cancer Support Centre (Ireland)
3. Solas Cancer Support Centre West Waterford (Ireland)

When is the study starting and how long is it expected to run for?
September 2014 to March 2018

Who is funding the study?
Waterford Institute of Technology (Ireland)

Who is the main contact?
1. Ms Patricia Sheehan (Scientific)
patricia.sheehan@postgrad.wit.ie
2. Dr Michael Harrisson (Scientific)
mharrison@wit.ie
3. Dr Suzanne Denieffe (Scientific)
sdenieffe@wit.ie

Trial website

Contact information

Type

Scientific

Primary contact

Ms Patricia Sheehan

ORCID ID

Contact details

Desk 4 Postgrad Room
Entrance level
Luke Wadding Library
Waterford Institute of Technology
Cork Road
Waterford
-
Ireland
+353 87 9670735
patricia.sheehan@postgrad.wit.ie

Type

Scientific

Additional contact

Dr Michael Harrisson

ORCID ID

Contact details

School of Science and Computing
Waterford Institute of Technology
Waterford
Waterford
-
Ireland
+353 51 302027
mharrison@wit.ie

Type

Scientific

Additional contact

Dr Suzanne Denieffe

ORCID ID

http://orcid.org/0000-0003-0238-4645

Contact details

Department of Nursing and Health Care
Waterford Institute of Technology
Waterford
-
Ireland
+353 51302473
SDENIEFFE@wit.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1725

Study information

Scientific title

Evaluation of a Sustainable Intervention using Exercise - for Cancer Fatigue (ESIE-CF Trial)

Acronym

ESIE-CF Trial

Study hypothesis

Research questions:
1. Does exercise/health education promote positive changes in fatigue, physical fitness, sleep, cognitive functioning and quality of life in cancer survivors following a 10 week exercise/health education program?
2. Are there greater positive changes in fatigue, physical fitness, sleep, cognitive functioning and quality of life in cancer survivors who participate in an exercise intervention compared to those in a health education intervention?
3. Is exercise more effective than health education in reducing cancer related fatigue in fatigued post treatment cancer survivors?

Ethics approval

Waterford Institute of Technology, The Health Service Executive South East and University Hospital Waterford, 10/06/2015

Study design

Interventional non randomised multi-centre cross over study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cancer related fatigue in post treatment cancer survivors

Intervention

This study is a quasi-experimental multi centre trial. A repeated measures design is being used comparing a ten week semi-supervised progressive exercise intervention to a non-exercise health education comparison condition, with crossover from the comparison (health education) to the exercise arm of the study at the end of the comparison period. Those who express interest are either sent or given an information letter. After providing written informed consent, participants obtain medical clearance from their general practitioner and complete baseline assessments. Participants are allocated to either the non-exercise health education or the progressive arm consecutively.

Arm 1: Exercisers meet twice per week (p/w) for the first five weeks reducing to once p/w for the remaining five weeks to enable sustainability of exercise on intervention completion. Classes are one-hour sessions and can include brisk walking, indoor circuits, flexibility and mobility. The classes include progressive aerobic exercise (both in volume and intensity) starting with low-moderate intensity. Exercise principally group based and supervised though allowing for individual differences in fitness and energy levels. Some home-based, potentially buddied activity included as intervention progresses. They include a combination of walking and indoor exercise classes as primary exercise mode. Walking sessions can include some interval work towards end of intervention to increase intensity intermittently as needed to ensure progression

Arm 2: The health education group meet once per week for ten weeks. One-hour sessions focus on strategies other than exercise to manage fatigue, such as food and nutrition, cognitive behaviour therapy and sleep management. Meetings emphasis positive health focus and peer support. The cognitive behaviour therapy includes structured briefing/induction session, study booklet particularly emphasizing exercise, cancer and fatigue, evidence, benefits, barriers, misconceptions, goal setting and review, session reviews (in diaries),monitoring and recording of intensity and volume (diaries),ongoing fitness and functional assessments (e.g. six min walk), one-to-one and group exercise counselling/motivational interviewing centered on fatigue, phone support in the case of non-attendance, study materials needed for self-monitoring and the identification of primary exercise buddy who can attend all sessions with study participant. Participants in this group have the option to crossover to the first group.

Participants are assessed for their fatigue using the FACT-F scale at baseline, week four, week eight, post intervention and at six month follow up. Blood and saliva samples are taken to measure markers that are believed to influence fatigue. Participants are only included in the study if they have a score of < 45. All other assessments take place at baseline, post intervention and at the six month follow up. Sustainability is measured at 6 months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Fatigue is measured using the FACT-F measured at baseline, week four, week eight, post intervention and at six month follow up.

Secondary outcome measures

1. Quality of life is measured using Quality of life (EORTC) questionnaire at baseline, post intervention, and at six month follow up
2. Fear of Physical Activity among breast cancer survivors is measured using Fear of Physical Activity and Exercise in Survivors of Breast Cancer questionnaire at baseline, post intervention, and at six month follow up
3. Sleep difficulties are measured using Insomnia Severity Index at post intervention, and at six month follow up
4. Self-efficacy in general health management is measured using the Perceived Health Competency questionnaire at baseline, post intervention, and at six month follow up
5. Fitness is measured using the six minute walk/run test, handgrip dynamometer, sit to stand test, sit & reach test and the one legged balance test at baseline, post intervention, and at six month follow up
6. Vascular function is measured using the arterial stiffness via pulse wave velocity at baseline, post intervention, and at six month follow up
7. Body weight, height and blood pressure are measured at baseline, post intervention, and at six month follow up
8. Physical activity levels are measured using the International Physical Activity Questionnaire (IPAQ) at baseline, post intervention, and at six month follow up
9. Salivary cortisol are measured using saliva samples at baseline and post intervention
10. Cytokines are measured using blood samples at baseline, post intervention, and at six month follow up

Overall trial start date

29/09/2014

Overall trial end date

01/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women and men
2. Aged 18 or older
3. Breast, colorectal and prostate cancer survivors
4. At least 6 weeks but not more than 10 years following the completion of surgery, radiotherapy and chemotherapy (to allow for stabilisation of fatigue following treatment) but not excluding those on ongoing hormonal therapy
5. Ongoing fatigue (FACT-F score <45) (the lower the score the higher the fatigue)
6. Currently undertaking less than 90 min or more of moderate intensity exercise weekly

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Inability to travel for testing and to group exercise/health education sites
2. GP unwilling to provide medical clearance for moderate intensity exercise
3. Orthopaedic limitations that render participant unable to participate in a class-based moderate intensity exercise programme
4. Currently undertaking 90 min or more of moderate intensity exercise weekly

Recruitment start date

26/06/2015

Recruitment end date

26/01/2017

Locations

Countries of recruitment

Ireland

Trial participating centre

University Hospital Waterford
Dunmore Road
Waterford
X91 ER8E
Ireland

Trial participating centre

Solas Cancer Support Centre
Williamstown
Waterford
-
Ireland

Trial participating centre

Solas Cancer Support Centre West Waterford
Main street, Dungarvan
Co. Waterford
-

Sponsor information

Organisation

Waterford Institute of Technology

Sponsor details

Cork Road
Waterford
-
Ireland
+ 353 51306260
scullinane@wit.ie

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Waterford Institute of Technology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository https://www.researchgate.net/project/Evaluation-of-a-Sustainable-Intervention-using-Exercise-for-Cancer-Fatigue-ESIE-CF-Trial. They will also be will be included in the subsequent results publication and will be available upon request from [patricia.sheehan@postgrad.wit.ie]

Intention to publish date

01/01/2018

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes