Case management vocational rehabilitation for women with breast cancer after surgery: a feasibility study incorporating a pilot randomised controlled trial

Gill Hubbard, Nicola M Gray, Dolapo Ayansina, Josie M M Evans, Richard G Kyle

Research output: Contribution to journalArticle

22 Citations (Scopus)
4 Downloads (Pure)

Abstract

Background
There is a paucity of methodologically robust vocational rehabilitation (VR) intervention trials. This study assessed the feasibility and acceptability of a VR trial of women with breast cancer to inform the development of a larger interventional study.

Methods
Women were recruited in Scotland and randomised to either a case management VR service or to usual care. Data were collected on eligibility, recruitment and attrition rates to assess trial feasibility, and interviews conducted to determine trial acceptability. Sick leave days (primary outcome) were self-reported via postal questionnaire every 4 weeks during the first 6 months post-surgery and at 12 months. Secondary outcome measures were change in employment pattern, quality of life and fatigue.

Results
Of the 1,114 women assessed for eligibility, 163 (15%) were eligible. The main reason for ineligibility was age (>65 years, n = 637, 67%). Of those eligible, 111 (68%) received study information, of which 23 (21%) consented to participate in the study. Data for 18 (78%) women were analysed (intervention: n = 7; control: n = 11). Participants in the intervention group reported, on average, 53 fewer days of sick leave over the first 6 months post-surgery than those in the control group; however, this difference was not statistically significant (p = 0.122; 95% confidence interval −15.8, 122.0). No statistically significant differences were found for secondary outcomes. Interviews with trial participants indicated that trial procedures, including recruitment, randomisation and research instruments, were acceptable.

Conclusions
Conducting a pragmatic trial of effectiveness of a VR intervention among cancer survivors is both feasible and acceptable, but more research about the exact components of a VR intervention and choice of outcomes to measure effectiveness is required. VR to assist breast cancer patients in the return to work process is an important component of cancer survivorship plans.
Original languageEnglish
Article number175
Number of pages14
JournalTrials
Volume14
DOIs
Publication statusPublished - 14 Jun 2013

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Vocational Rehabilitation
Case Management
Feasibility Studies
Randomized Controlled Trials
Breast Neoplasms
Sick Leave
Pragmatic Clinical Trials
Outcome Assessment (Health Care)
Interviews
Return to Work
Scotland
Random Allocation
Research
Fatigue
Survivors
Neoplasms
Survival Rate
Quality of Life
Confidence Intervals
Control Groups

Keywords

  • absenteeism
  • adolescent
  • adult
  • aged
  • breast neoplasms
  • case management
  • eligibility determination
  • fatigue
  • feasibility studies
  • female
  • humans
  • interviews as topic
  • mastectomy
  • middle aged
  • pilot projects
  • quality of life
  • questionnaires
  • rehabilitation, vocational
  • research design
  • return to work
  • Scotland
  • sick leave
  • time factors
  • treatment outcome
  • young adult

Cite this

Case management vocational rehabilitation for women with breast cancer after surgery : a feasibility study incorporating a pilot randomised controlled trial. / Hubbard, Gill; Gray, Nicola M; Ayansina, Dolapo; Evans, Josie M M; Kyle, Richard G.

In: Trials, Vol. 14, 175, 14.06.2013.

Research output: Contribution to journalArticle

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title = "Case management vocational rehabilitation for women with breast cancer after surgery: a feasibility study incorporating a pilot randomised controlled trial",
abstract = "BackgroundThere is a paucity of methodologically robust vocational rehabilitation (VR) intervention trials. This study assessed the feasibility and acceptability of a VR trial of women with breast cancer to inform the development of a larger interventional study.MethodsWomen were recruited in Scotland and randomised to either a case management VR service or to usual care. Data were collected on eligibility, recruitment and attrition rates to assess trial feasibility, and interviews conducted to determine trial acceptability. Sick leave days (primary outcome) were self-reported via postal questionnaire every 4 weeks during the first 6 months post-surgery and at 12 months. Secondary outcome measures were change in employment pattern, quality of life and fatigue.ResultsOf the 1,114 women assessed for eligibility, 163 (15{\%}) were eligible. The main reason for ineligibility was age (>65 years, n = 637, 67{\%}). Of those eligible, 111 (68{\%}) received study information, of which 23 (21{\%}) consented to participate in the study. Data for 18 (78{\%}) women were analysed (intervention: n = 7; control: n = 11). Participants in the intervention group reported, on average, 53 fewer days of sick leave over the first 6 months post-surgery than those in the control group; however, this difference was not statistically significant (p = 0.122; 95{\%} confidence interval −15.8, 122.0). No statistically significant differences were found for secondary outcomes. Interviews with trial participants indicated that trial procedures, including recruitment, randomisation and research instruments, were acceptable.ConclusionsConducting a pragmatic trial of effectiveness of a VR intervention among cancer survivors is both feasible and acceptable, but more research about the exact components of a VR intervention and choice of outcomes to measure effectiveness is required. VR to assist breast cancer patients in the return to work process is an important component of cancer survivorship plans.",
keywords = "absenteeism, adolescent, adult, aged, breast neoplasms, case management, eligibility determination, fatigue, feasibility studies, female, humans, interviews as topic, mastectomy, middle aged, pilot projects, quality of life, questionnaires, rehabilitation, vocational, research design, return to work, Scotland, sick leave, time factors, treatment outcome, young adult",
author = "Gill Hubbard and Gray, {Nicola M} and Dolapo Ayansina and Evans, {Josie M M} and Kyle, {Richard G}",
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T1 - Case management vocational rehabilitation for women with breast cancer after surgery

T2 - a feasibility study incorporating a pilot randomised controlled trial

AU - Hubbard, Gill

AU - Gray, Nicola M

AU - Ayansina, Dolapo

AU - Evans, Josie M M

AU - Kyle, Richard G

PY - 2013/6/14

Y1 - 2013/6/14

N2 - BackgroundThere is a paucity of methodologically robust vocational rehabilitation (VR) intervention trials. This study assessed the feasibility and acceptability of a VR trial of women with breast cancer to inform the development of a larger interventional study.MethodsWomen were recruited in Scotland and randomised to either a case management VR service or to usual care. Data were collected on eligibility, recruitment and attrition rates to assess trial feasibility, and interviews conducted to determine trial acceptability. Sick leave days (primary outcome) were self-reported via postal questionnaire every 4 weeks during the first 6 months post-surgery and at 12 months. Secondary outcome measures were change in employment pattern, quality of life and fatigue.ResultsOf the 1,114 women assessed for eligibility, 163 (15%) were eligible. The main reason for ineligibility was age (>65 years, n = 637, 67%). Of those eligible, 111 (68%) received study information, of which 23 (21%) consented to participate in the study. Data for 18 (78%) women were analysed (intervention: n = 7; control: n = 11). Participants in the intervention group reported, on average, 53 fewer days of sick leave over the first 6 months post-surgery than those in the control group; however, this difference was not statistically significant (p = 0.122; 95% confidence interval −15.8, 122.0). No statistically significant differences were found for secondary outcomes. Interviews with trial participants indicated that trial procedures, including recruitment, randomisation and research instruments, were acceptable.ConclusionsConducting a pragmatic trial of effectiveness of a VR intervention among cancer survivors is both feasible and acceptable, but more research about the exact components of a VR intervention and choice of outcomes to measure effectiveness is required. VR to assist breast cancer patients in the return to work process is an important component of cancer survivorship plans.

AB - BackgroundThere is a paucity of methodologically robust vocational rehabilitation (VR) intervention trials. This study assessed the feasibility and acceptability of a VR trial of women with breast cancer to inform the development of a larger interventional study.MethodsWomen were recruited in Scotland and randomised to either a case management VR service or to usual care. Data were collected on eligibility, recruitment and attrition rates to assess trial feasibility, and interviews conducted to determine trial acceptability. Sick leave days (primary outcome) were self-reported via postal questionnaire every 4 weeks during the first 6 months post-surgery and at 12 months. Secondary outcome measures were change in employment pattern, quality of life and fatigue.ResultsOf the 1,114 women assessed for eligibility, 163 (15%) were eligible. The main reason for ineligibility was age (>65 years, n = 637, 67%). Of those eligible, 111 (68%) received study information, of which 23 (21%) consented to participate in the study. Data for 18 (78%) women were analysed (intervention: n = 7; control: n = 11). Participants in the intervention group reported, on average, 53 fewer days of sick leave over the first 6 months post-surgery than those in the control group; however, this difference was not statistically significant (p = 0.122; 95% confidence interval −15.8, 122.0). No statistically significant differences were found for secondary outcomes. Interviews with trial participants indicated that trial procedures, including recruitment, randomisation and research instruments, were acceptable.ConclusionsConducting a pragmatic trial of effectiveness of a VR intervention among cancer survivors is both feasible and acceptable, but more research about the exact components of a VR intervention and choice of outcomes to measure effectiveness is required. VR to assist breast cancer patients in the return to work process is an important component of cancer survivorship plans.

KW - absenteeism

KW - adolescent

KW - adult

KW - aged

KW - breast neoplasms

KW - case management

KW - eligibility determination

KW - fatigue

KW - feasibility studies

KW - female

KW - humans

KW - interviews as topic

KW - mastectomy

KW - middle aged

KW - pilot projects

KW - quality of life

KW - questionnaires

KW - rehabilitation, vocational

KW - research design

KW - return to work

KW - Scotland

KW - sick leave

KW - time factors

KW - treatment outcome

KW - young adult

U2 - 10.1186/1745-6215-14-175

DO - 10.1186/1745-6215-14-175

M3 - Article

C2 - 23768153

VL - 14

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 175

ER -