Condition category
Cancer
Date applied
10/09/2010
Date assigned
07/10/2010
Last edited
21/06/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gill Hubbard

ORCID ID

Contact details

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
+44 (0)1786 849260
gill.hubbard@stir.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A feasibility study for a single-blind, randomised controlled trial of vocational rehabilitation services for patients with cancer

Acronym

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

Tayside Committee on Medical Research Ethics A approved on the 26th March 2010 (ref: 10/S1401/15)

Study design

Interventional single-blind randomised controlled multicentre feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

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

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/03/2010

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

66

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

United Kingdom

Trial participating centre

Cancer Care Research Centre
Stirling
FK9 4NF
United Kingdom

Sponsor information

Organisation

University of Stirling (UK)

Sponsor details

Research and Enterprise Office
3B1 Cottrell Building
Stirling
FK9 4LA
United Kingdom
+44 (0)1786 466690
carol.johnstone@stir.ac.uk

Sponsor type

University/education

Website

http://www.stir.ac.uk/

Funders

Funder type

Charity

Funder name

Macmillan Cancer Support (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Scottish Centre for Healthy Working Lives (UK)

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

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21450089
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23768153

Publication citations

  1. Protocol

    Kyle RG, Culbard B, Evans J, Gray NM, Ayansina D, Hubbard G, Vocational rehabilitation services for patients with cancer: design of a feasibility study incorporating a pilot randomised controlled trial among women with breast cancer following surgery., Trials, 2011, 12, 89, doi: 10.1186/1745-6215-12-89.

  2. Results

    Hubbard G, Gray NM, Ayansina D, Evans JM, Kyle RG, Case management vocational rehabilitation for women with breast cancer after surgery: a feasibility study incorporating a pilot randomised controlled trial., Trials, 2013, 14, 175, doi: 10.1186/1745-6215-14-175.

Additional files

Editorial Notes