PLACES: Enhancing Work Participation of Unemployed and Work-Disabled Cancer Survivors

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06028048
Collaborator
(none)
164
2
24

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the effectiveness of the PLACES intervention on paid employment re-entry in unemployed and work-disabled cancer survivors, compared to CAU.

Secondary Objectives are:
  • To evaluate the cost-effectiveness of the PLACES intervention aimed at unemployed or work-disabled cancer survivors.

  • To evaluate the effectiveness of the PLACES intervention on time until paid employment, type of employment, change in working hours, quality of life, quality of working life, work ability, and self-efficacy regarding RTW, in unemployed or work-disabled cancer survivors.

  • To evaluate the process of conducting the PLACES intervention in terms of recruitment, reach, dose delivered, dose received, fidelity and context.

Participants in the intervention group will receive the PLACES intervention with a maximum duration of 1 year, and participants in the control group will receive CAU.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PLACES
Phase 2/Phase 3

Detailed Description

About one third of all cancer survivors is not able to re-integrate into work and experiences involuntary unemployment or partial or full work disability due to their cancer diagnosis and treatment. For cancer survivors who lost their job, returning to paid employment can be challenging due to uncertainty about their work ability, perceived employer discrimination and a lack of support. They are at risk for social exclusion, yet return to work (RTW) interventions are currently missing. Here, the protocol of the PLACES (unemPLoyed cAnCer survivors Support) study is described. The aim of this study is to evaluate the effectiveness and cost-effectiveness of a supported employment intervention on enhancing successful RTW of unemployed and partly or fully work-disabled cancer survivors.

A two-armed randomized controlled trial (RCT) will be carried out with a follow-up of 12-months. Eligible participants are: 1) aged between 18 and 65 years; 2) diagnosed with cancer between 6 months and 10 years ago; 3) unemployed and partly or fully work-disabled; 4) seeking paid employment; and 5) motivated to immediately start working in a new job. Participants will be identified via the Netherlands Cancer Registry and recruited through their medical specialist at the hospital or labour expert at the social security agency. Participants in the intervention group (n=82) will receive a tailored supported employment intervention, based on the principles of individual placement and support (IPS). This includes support in seeking, returning to and maintaining paid employment. Participants in the control group (n=82) will receive care as usual. All participants will be asked to complete questionnaires, at baseline (T0), and after three (T1), six (T2) and 12 months (T3) follow-up. The primary outcome is obtainment of paid employment. Secondary outcomes are employment status, time until paid employment, change in working hours, importance of work, RTW expectations, work ability, quality of (working) life, and self-efficacy regarding RTW. Process evaluation and cost-effectiveness analysis will be performed.

We expect that that a significantly higher proportion of participants in the intervention group to obtain paid employment at any point during 12-month follow-up compared to participants in the control group. Additionally, their health, financial situation and quality of life will be improved. If proven effective, the intention is to implement the intervention in usual rehabilitation care.

The study is funded by the Dutch Cancer Society (KWF) and in collaboration with the Netherlands comprehensive cancer organisation (IKNL) and the social security agency (SSA)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
164 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A non-blinded RCT will be conducted with a follow-up of 12 months. The study will compare two arms: (1) an intervention group, in which participants will receive the PLACES intervention, and (2) a control group, in which participants will receive CAU (Figure 1). Data on primary (i.e. obtainment of paid employment) and secondary outcomes (e.g. quality of life and self-efficacy regarding RTW) will be gathered at baseline (T0) and after three (T1), six (T2) and twelve months of follow up (T3) using questionnaires .A non-blinded RCT will be conducted with a follow-up of 12 months. The study will compare two arms: (1) an intervention group, in which participants will receive the PLACES intervention, and (2) a control group, in which participants will receive CAU (Figure 1). Data on primary (i.e. obtainment of paid employment) and secondary outcomes (e.g. quality of life and self-efficacy regarding RTW) will be gathered at baseline (T0) and after three (T1), six (T2) and twelve months of follow up (T3) using questionnaires .
Masking:
Single (Outcomes Assessor)
Masking Description:
The analyses will be performed blinded after one researcher codes the intervention and control group to either 0 or 1.
Primary Purpose:
Other
Official Title:
Protocol of a Randomized Controlled Trial on the Effectiveness and Cost-effectiveness of a Supported Employment Intervention Aimed at Enhancing Work Participation of Unemployed or Work-disabled Cancer Survivors: the PLACES Study
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: PLACES intervention

Participants in the intervention group will receive the PLACES intervention during 12-months after randomization.

Behavioral: PLACES
The PLACES intervention is based on eight IPS principles, ensuring competitive employment, client choice, service integration, personalized benefits counseling, rapid job search, systematic development, and individualized support. Coaches: Certified IPS coaches receive training from Phrenos IPS knowledge center and Re-turn. Ongoing support includes video lectures, clarifications with researchers, and biannual collective sessions. Coaches, regionally specialized, implement interventions autonomously. Intervention Phases: Intake and Assessment: Participants meet IPS coaches within three days to discuss goals, procedures, and responsibilities, continuing until objectives are met. Acquisition and Application: Coaches assist job search and placement, aiming for employment within 30 days. Placement and Support: Coaches offer personalized support, adapting to needs, scheduling meetings based on preferences. The intervention ends at 12 months or when goals are achieved.
Other Names:
  • Individual Placement and Support (IPS)
  • Supported employment
  • No Intervention: Care as usual

    Participants in the control group will receive usual care from the SSA.

    Outcome Measures

    Primary Outcome Measures

    1. Paid employment (yes/no) [12 months]

      The primary outcome measure is paid employment (yes/no) at any point during the 1-year-follow-up. Being in paid employment is operationalised as working in a paid job for at least one hour per week as defined by the central statistics office.

    Secondary Outcome Measures

    1. Employment status [Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)]

      participants will be ask about their current work situation. A combination of answer options is possible: fulltime, parttime, self-employed, studying, retired, involuntary unemployed, voluntary unemployed, (partially) work-disabled, employed but on sick leave, unemployed and on sick leave, household/caring for others, and 'other'.

    2. Time until paid employment [Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)]

      2. Time until paid employment will be measured as the number of calendar days between randomization and the first day at paid employment. Participants will be asked about the date they started their new job. This can be used to calculate the number of days between randomization and starting in a new job.

    3. Change in working hours [Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)]

      for each current work situation (e.g. part-time, voluntary, etc.) participants will be asked about the number of hours per week they work.The answers at different times of follow-up will be used to calculate the change in working hours.

    4. Importance of work [Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)]

      4. Importance of work will be measured by rating the perceived importance of work in one's current situation on a visual analogue scale (VAS) ranging from 1 to 10, with higher scores indicating higher importance of work.

    5. RTW expectations [Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)]

      5. RTW expectation will be measured using a single question asking participants: 'in your estimation, what is the chance you will be at work in 6 months, measured on a 10-point rating scale from 1 (Very little chance) to 5 (very high chance).

    6. Work ability [Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)]

      6. Work ability will be assessed using a single question of the Work Ability Index (WAI), asking participants to estimate their current work ability compared with their lifetime best (0, cannot work at all, to 10, best ever)

    7. Quality of life [Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)]

      7. Quality of life will be assessed with the Short Form-12 (SF-12), which includes the subscales vitality, physical functioning, bodily pain, general health perceptions, physical role functioning.

    8. Quality of working life [Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)]

      8. Quality of working life will be measured with the 23-item cancer-specific quality of working life questionnaire (QWLQ-CS, 23 items)

    9. Self-efficacy regarding RTW [Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)]

      9. Self-efficacy regarding RTW is measured using the 11-item self-efficacy scale developed by Lagerveld et al. with higher scores indicating higher self-efficacy for RTW

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    In order to be eligible for participation, participants must meet all of the following criteria:

    1. Of working age (18-65 years);

    2. Diagnosed with cancer between 6 months and 10 years ago;

    3. Unemployed and either partially or fully work-disabled

    4. They have completed their primary treatment (except long-term treatment such as hormone therapy);

    5. An approved reintegration trajectory at the SSA;

    6. Seeking paid employment and motivated to initiate work promptly.

    Cancer survivors who are unable to speak, read or understand the Dutch language and cancer survivors who got diagnosed with basal cell carcinoma will be excluded from participation.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fenna van Ommen, Prof. dr. Angela de Boer, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    ClinicalTrials.gov Identifier:
    NCT06028048
    Other Study ID Numbers:
    • 24535
    First Posted:
    Sep 7, 2023
    Last Update Posted:
    Sep 7, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fenna van Ommen, Prof. dr. Angela de Boer, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    Study Results

    No Results Posted as of Sep 7, 2023