Vocational rehabilitation services for patients with cancer: a feasibility study for a randomised controlled trial
| ISRCTN | ISRCTN29666484 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29666484 |
| Protocol serial number | N/A |
| Sponsor | University of Stirling (UK) |
| Funders | Macmillan Cancer Support (UK), Scottish Centre for Healthy Working Lives (UK) |
- Submission date
- 10/09/2010
- Registration date
- 07/10/2010
- Last edited
- 21/06/2013
- 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
Not provided at time of registration
Contact information
Dr Gill Hubbard
Scientific
Scientific
Cancer Care Research Centre
Department of Nursing and Midwifery
University of Stirling
Unit 1 Scion House
Stirling University Innovation Park
Stirling
FK9 4NF
United Kingdom
| Phone | +44 (0)1786 849260 |
|---|---|
| gill.hubbard@stir.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional single-blind randomised controlled multicentre feasibility study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A feasibility study for a single-blind, randomised controlled trial of vocational rehabilitation services for patients with cancer |
| Study objectives | This study aims to determine whether a single-blind randomised controlled trial of vocational rehabilitation services is feasible and the intervention acceptable among patients living with cancer. |
| Ethics approval(s) | Tayside Committee on Medical Research Ethics A approved on the 26th March 2010 (ref: 10/S1401/15) |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | The intervention is referral to a vocational rehabilitation service compared with usual care. Intervention: All participants allocated to the Intervention arm of the trial will be contacted by a vocational rehabilitation service by telephone within 10 days following recruitment to the study. The case manager will conduct a telephone assessment of supportive care needs to facilitate remaining in or returning to work. The case manager will signpost participants to support services including physiotherapy, occupational therapy, occupational health nurse, occupational health doctor, counsellor/psychological therapy, complementary therapy. Usual Care: Usual care following surgery involves no formal employment support. Questionnaires will be administered to participants in both the Intervention and Usual Care arms on entry to the trial and again following 6 and 12 months of follow-up. |
| Intervention type | Other |
| Primary outcome measure(s) |
Self-reported sickness absence within the first six months post-surgery |
| Key secondary outcome measure(s) |
1. Quality of life measured using the FACT-B questionnaire at baseline, 6 and 12 months of follow-up |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 66 |
| Key inclusion criteria | 1. Adults aged between 18 and 65 years old who are diagnosed with an invasive breast cancer tumour whose first treatment is surgery 2. In paid employment 3. Live or work in Lothian or Tayside, Scotland |
| Key exclusion criteria | 1. Anyone under the age of 18 years or over 65 years old 2. Anyone not in paid employment or self-employed 3. Does not live or work in Lothian or Tayside, Scotland |
| Date of first enrolment | 01/03/2010 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Cancer Care Research Centre
Stirling
FK9 4NF
United Kingdom
FK9 4NF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/06/2013 | Yes | No | |
| Protocol article | protocol | 30/03/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
