Rehabilitation evaluation in survivors of testicular cancer after radical treatment

ISRCTN	ISRCTN77608320
DOI	https://doi.org/10.1186/ISRCTN77608320
Secondary identifying numbers	RESTART-2011

Submission date: 15/01/2013
Registration date: 29/01/2013
Last edited: 21/02/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-rehabilitation-programme-men-completed-treatment-testicular-cancer-restart

Contact information

Dr Jeff White
Scientific

The Beatson West of Scotland Cancer Centre
Level 3
1053 Great Western Road
Glasgow
G11 6NT
United Kingdom

Phone	+44 (0)141 301 7060
Email	jeffwhite@nhs.net

Study information

Study design	Phase II non-randomised feasibility study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	RESTART: Rehabilitation Evaluation in Survivors of Testicular Cancer After Radical Treatment: a pilot study
Study acronym	RESTART
Study objectives	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(s)	West of Scotland REC 1, 18/08/2011, REC Ref: 11/WS/0007
Health condition(s) or problem(s) studied	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
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 study start date	19/01/2012
Completion date	01/01/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	32
Total final enrolment	35
Key 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
Key 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
Date of first enrolment	19/01/2012
Date of final enrolment	01/01/2014

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

The Beatson West of Scotland Cancer Centre

Glasgow
G11 6NT
United Kingdom

Sponsor information

NHS Greater Glasgow and Clyde (UK)
Hospital/treatment centre

c/o Dr Nathaniel Brittain
Research and Development Central Office
The Tennent Institute, 1st Floor
Western Infirmary
38 Church Street
Glasgow
G11 6NT
Scotland
United Kingdom

Website	http://www.nhsggc.org.uk/r&d
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Charity

Macmillan Cancer Support (UK)

No information available

National Institute for Health Research Cancer Research Network (NCRN)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Plain English results			No	Yes
Results article	results	20/05/2013	Yes	No
Abstract results	results	04/11/2013	No	No

Editorial Notes

21/02/2020: Publication reference and total final enrolment number added.
06/08/2019: A link to results (plain English) was added.
06/07/2018: Publication reference added.
23/05/2016: No publications found, verifying study status with principal investigator.