Condition category
Cancer
Date applied
15/01/2013
Date assigned
29/01/2013
Last edited
23/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.nhsggc.org.uk/r&d

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

23/05/2016: No publications found, verifying study status with principal investigator.