Clinical trial NCT06028048: Enhancing Work Participation of Unemployed and Work-Disabled Cancer Survivors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Cancer Survivors
Return to Work
Keywords: Cancer survivors
Return to Work
Reintegration
Unemployment
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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. 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 .
Primary purpose: OTHER

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.

Detailed 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)

Eligibility 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.

Primary outcomes:
measure: Paid employment (yes/no)
timeFrame: 12 months
Secondary outcomes:
measure: Employment status
timeFrame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
measure: Time until paid employment
timeFrame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
measure: Change in working hours
timeFrame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
measure: Importance of work
timeFrame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
measure: RTW expectations
timeFrame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
measure: Work ability
timeFrame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
measure: Quality of life
timeFrame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
measure: Quality of working life
timeFrame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
measure: Self-efficacy regarding RTW
timeFrame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
Other outcomes:
Locations:
city: Haarlem
country: Netherlands
facility: UWV
city: Zaandam
country: Netherlands
facility: UWV Zaandam
Study officials:
References: