Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jeff White
ORCID ID
Contact details
The Beatson West of Scotland Cancer Centre
Level 3
1053 Great Western Road
Glasgow
G11 6NT
United Kingdom
+44 (0)141 301 7060
jeffwhite@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RESTART-2011
Study information
Scientific title
RESTART: Rehabilitation Evaluation in Survivors of Testicular Cancer After Radical Treatment: a pilot study
Acronym
RESTART
Study hypothesis
The primary aim is to establish the components of a rehabilitation programme for testis cancer. In addition, we wish to measure the magnitude of effect using the change in Hospital Anxiety and Depression Scale (HADS) anxiety sub-score from pre to post the programme.
The median return to work/education time will also be estimated for the participants as background information for designing any subsequent phase III study.
The aim is to then set up a phase III trial to definitively investigate if such a programme may influence early reduction in treatment related anxiety and the time to return to employment following radical treatment of testis cancer compared to the current standard of care.
Secondary aims are assessment of the effect of the rehabilitation programme on Quality of Life (QOL), HAD depression sub-score, fatigue, exercise capacity and body mass index (BMI).
Ethics approval
West of Scotland REC 1, 18/08/2011, REC Ref: 11/WS/0007
Study design
Phase II non-randomised feasibility study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Testicular cancer
Intervention
All patients who enter the study will take part in a six week rehabilitation programme in order to facilitate improvement in functional ability and psychological well being following treatment of testicular cancer. Specific components will be introduced to address the needs of this particular population group.
In addition to the exercise component, recreational and social elements to the programme, topics that will be included are:-
1. Healthy living advice (alcohol, diet, exercise, sun awareness)
2. Return to work
3. Role of Occupational Health Physician or Nurse
4. Financial issues
5. Insurance
6. Advice on recognising recurrence
7. Accessing more information and support service for testis cancer
8. Coping with life after a serious illness how to be positive
9. Fertility
As part of the exercise component, participants will wear a pedometer for the 6 weeks the rehabilitation programme takes place. They will record readings in an exercise diary each night. In addition they will record daily exercise activity.
Each of the components will be delivered by a specialist in that field. In addition, the course will be lead by co-ordinator with background experience in cancer rehabilitation.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Pilot study to establish the components of a rehabilitation programme for testis cancer and the effect of the programme by measuring change in the HADS anxiety sub score-from pre to post participation.
The aim is to then set up a phase III trial to definitively investigate if such a programme may influence early reduction in treatment related anxiety and the time to return to employment following radical treatment of testis cancer compared to the current standard of care.
Secondary outcome measures
Assessment of the effect of the rehabilitation programme on:
1. Fatigue
2. Exercise capacity
3. HADS depression sub score
4. BMI
Measured pre and post rehabilitation programme.
Overall trial start date
19/01/2012
Overall trial end date
01/01/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Ability to commence rehabilitation programme within 8 weeks of confirmed completion of all radical treatment for testis cancer ((including all surgical procedures, such as retroperitoneal lymph node dissection) If surveillance, the date this is confirmed as their management / Date of recovery from last surgical procedure or chemotherapy).
2. No major cardio-respiratory problems, which would influence participation in an exercise programme.
3. Male aged 16 or over
4. Ability to provide written informed consent
5. Geographically close enough to site of rehabilitation programme or prepared to travel necessary distances involved
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
32
Participant exclusion criteria
1. Alcohol / drug dependency
2. Cognitive dysfunction
3. Psychological distress that the referring clinician feels may make the individual not suitable for trial
Recruitment start date
19/01/2012
Recruitment end date
01/01/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Beatson West of Scotland Cancer Centre
Glasgow
G11 6NT
United Kingdom
Sponsor information
Organisation
NHS Greater Glasgow and Clyde (UK)
Sponsor details
c/o Dr Nathaniel Brittain
Research and Development Central Office
The Tennent Institute
1st Floor
Western Infirmary
38 Church Street
Glasgow
G11 6NT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Macmillan Cancer Support (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Institute for Health Research Cancer Research Network (NCRN)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in http://ascopubs.org/doi/abs/10.1200/jco.2013.31.15_suppl.9590