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Enhancing Work Participation of Unemployed and Work-Disabled Cancer Survivors (PLACES)

A

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

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Cancer Survivors
Return to Work

Treatments

Behavioral: PLACES

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

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.

It is expected that that a significantly higher proportion of participants in the intervention group will 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)

Enrollment

164 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

164 participants in 2 patient groups

PLACES intervention
Experimental group
Description:
Participants in the intervention group will receive the PLACES intervention during 12-months after randomization.
Treatment:
Behavioral: PLACES
Care as usual
No Intervention group
Description:
Participants in the control group will receive usual care from the SSA.

Trial contacts and locations

2

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Central trial contact

Fenna van Ommen, Msc.

Data sourced from clinicaltrials.gov

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