Condition category
Cancer
Date applied
14/01/2015
Date assigned
15/01/2015
Last edited
15/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Joanne Fisher

ORCID ID

Contact details

University of Warwick
Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15361

Study information

Scientific title

PRO-REHAB - The development and pilot trial of two programmes of rehabilitation for cancer patients: a pilot randomised controlled trial

Acronym

PRO-REHAB

Study hypothesis

What effect on participants’ quality of life, well-being, physical and psychological functioning and perception of distress does: (i) an individualised home-based rehabilitation programme, facilitated by allied health professionals or (ii) a group-based rehabilitation programme, facilitated by a multidisciplinary team of allied health professionals have, compared to usual care?

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=15361

Ethics approval

NRES Committee West Midlands, Solihull, ref: 13/WM/0340

Study design

Randomised; Interventional and Observational

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

Rehabilitation for cancer patients following the end of their treatment

Intervention

The two intervention arms of this three-arm randomised control trial are home-based rehabilitation and group-based rehabilitation programmes.

The home-based programme is an individualised holistic rehabilitaion programme, developed jointly by the participant and a personal allied health professional and delivered over 10 weeks. Particpants can choose from a wide range of areas, activities and topics that they would like to improve or change in their lives. Participants who would like to improve activity will recieive an individualised exercise programme, developed by specialist exercise physiologists. The programme will be supported by a workbook with a goal diary and CD-based relaxation.

The group-based programme is an holistic rehabilitaion prgramme, developed jointly by the group (maximum 10 people) and a multi-disciplinary team of allied health professionals and delivered over 10 weeks. Participants can choose from a wide range of areas, activities and topics that they would like to improve or change in their lives. Participants who would like to improve activity will recieive an individualised exercise programme, developed by specialist exercise physiologists. The programme will be supported by a workbook with a goal diary and CD-based relaxation.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Identification and recruitment of participants, and recruitment strategies
2. Sample size calculations for a future multi-centre trial

Secondary outcome measures

1. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-EORTC QLQ-C30 (version 3)
2. Generalised Anxiety Disorder Assessment (GAD-7)
3. Euroqol quality of life questionnaire (5 item) - EQ5D-5L
4. Patient Health Questionnaire (PHQ-9)
5. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
6. The Distress Thermometer
7. Incremental Shuttle Walk Test (ISWT) score
8. Joint British Societies recommendations on the prevention of Cardiovascular Disease (JBS3) score
9. Malnutrition Universal Screening Tools score (MUST)

Overall trial start date

02/07/2014

Overall trial end date

31/08/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Patients:
1. With cancer (breast, colorectal, head and neck, lung and prostate) of any stage, will be invited to participate along with their carers
2. Who have completed the initial phase of intensive intervention (surgery, chemotherapy and/or radiotherapy)
3. Are able to read written and comprehend spoken English
4. Are aged 18 years and over
5. Are able and willing to give informed consent; Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 170; UK Sample Size: 170; Description: A sample size of 150 patients (50 patients on each arm) in the pilot trial will be sufficient to give an indication of the feasibility of the full trial. This sample size will allow the mean difference in pre and post intervention scores on the global quality of life scale from the EORTC QLQ-C30 questionnaire to be estimated to within 6% with 95% confidence, i.e. 95% confidence interval (CI) width of 12%, for each arm, assuming a standard deviation of 20.

Participant exclusion criteria

Patients:
1. Aged less than 18 years
2. With a history of severe psychiatric disorder

Recruitment start date

02/07/2014

Recruitment end date

31/08/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Warwick
Clinical Trials Unit Warwick Medical School Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

University of Warwick

Sponsor details

Warwick Medical School
Coventry
CV4 7AL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Fisher JD, Furze, G, Marshall, A, Young A. The development and pilot trial of two programmes of rehabilitation for cancer patients. 18th International Society of Nurses in Cancer Care: Panama City, Panama 2014.

Publication citations

Additional files

Editorial Notes