Enhancing Work Participation of Unemployed and Work-Disabled Cancer Survivors

Cancer Survivors Clinical Trial

— PLACES  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06028048
• Other study ID #: 24535
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: September 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Fenna van Ommen, Msc.
• Phone: +31613812892
• Email: f.vanommen1[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Survivors
• Return to Work

Intervention

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.

Locations

Country	Name	City	State
Netherlands	UWV	Haarlem
Netherlands	UWV Zaandam	Zaandam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paid employment (yes/no)	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.	12 months
Secondary	Employment status	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'.	Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
Secondary	Time until paid employment	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.	Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
Secondary	Change in working hours	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.	Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
Secondary	Importance of work	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.	Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
Secondary	RTW expectations	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).	Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
Secondary	Work ability	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)	Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
Secondary	Quality of life	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. Scores range from 0 to 100, with higher scores indicating higher quality of life.	Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
Secondary	Quality of working life	Quality of working life will be measured with the 23-item cancer-specific quality of working life questionnaire (QWLQ-CS, 23 items). Scores range from 0 to 100 with higher scores indicating a better quality of working life.	Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
Secondary	Self-efficacy regarding RTW	Self-efficacy regarding RTW is measured using the 11-item self-efficacy scale developed by Lagerveld et al. Each item is rated on a 6-point scale and an average score is used to determine the self-efficacy with a higher score (between 1 and 6) indicating better self-efficacy for RTW.	Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)