Enhancing Work Participation of Unemployed and Work-Disabled Cancer Survivors

NCT ID: NCT06028048

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-09-01

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)

Conditions

Cancer Survivors; Return to Work

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

PLACES intervention

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

Group Type: EXPERIMENTAL

PLACES

Intervention Type: BEHAVIORAL

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:

1. Intake and Assessment: Participants meet IPS coaches within three days to discuss goals, procedures, and responsibilities, continuing until objectives are met.

2. Acquisition and Application: Coaches assist job search and placement, aiming for employment within 30 days.

3. 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.

Care as usual

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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:

1. Intake and Assessment: Participants meet IPS coaches within three days to discuss goals, procedures, and responsibilities, continuing until objectives are met.

2. Acquisition and Application: Coaches assist job search and placement, aiming for employment within 30 days.

3. 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Individual Placement and Support (IPS); Supported employment

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Fenna van Ommen

Prof. dr. Angela de Boer, Professor in Chronic Disease and Work Participation at the Faculty of Medicine at Amsterdam UMC.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UWV

Haarlem, , Netherlands

Site Status: RECRUITING

UWV Zaandam

Zaandam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Fenna van Ommen, Msc.

Role: CONTACT

f.vanommen1@amsterdamumc.nl

+31613812892

Facility Contacts

Wim Buijs

Role: primary

Imke Odé

Role: primary

References

van Ommen F, Duijts SFA, Coenen P, Dalton SO, Kliffen A, van Hummel R, de Boer AGEM, Greidanus MA. Protocol of a randomized controlled trial on the effectiveness and cost-effectiveness of the PLACES intervention: a supported employment intervention aimed at enhancing work participation of unemployed and/or work-disabled cancer survivors. Trials. 2024 Sep 9;25(1):603. doi: 10.1186/s13063-024-08441-x.

Reference Type: DERIVED

PMID: 39252084 (View on PubMed)

Other Identifiers

24535

Identifier Type: -

Identifier Source: org_study_id