Vocational rehabilitation services for patients with cancer: a feasibility study for a randomised controlled trial

ISRCTN	ISRCTN29666484
DOI	https://doi.org/10.1186/ISRCTN29666484
Secondary identifying numbers	N/A

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

Not provided at time of registration

Contact information

Dr Gill Hubbard
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
Email	gill.hubbard@stir.ac.uk

Study information

Study design	Interventional single-blind randomised controlled multicentre feasibility study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
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	A feasibility study for a single-blind, randomised controlled trial of vocational rehabilitation services for patients with cancer
Study hypothesis	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)
Condition	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	Self-reported sickness absence within the first six months post-surgery
Secondary outcome measures	1. Quality of life measured using the FACT-B questionnaire at baseline, 6 and 12 months of follow-up 2. Fatigue measured using the FACT-F questionnaire at baseline, 6 and 12 months of follow-up 3. Change in employment status measured at baseline, 6 and 12 months of follow-up
Overall study start date	01/03/2010
Overall study end date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	66
Participant 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
Participant 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
Recruitment start date	01/03/2010
Recruitment end date	31/12/2011

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Cancer Care Research Centre

Stirling
FK9 4NF
United Kingdom

Sponsor information

University of Stirling (UK)
University/education

Research and Enterprise Office
3B1 Cottrell Building
Stirling
FK9 4LA
Scotland
United Kingdom

Phone	+44 (0)1786 466690
Email	carol.johnstone@stir.ac.uk
Website	http://www.stir.ac.uk/
"ROR"	https://ror.org/045wgfr59

Funders

Funder type

Charity

Macmillan Cancer Support (UK)

No information available

Scottish Centre for Healthy Working Lives (UK)

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	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	30/03/2011		Yes	No
Results article	results	14/06/2013		Yes	No