Enhancing Work Participation of Unemployed and Work-Disabled Cancer Survivors

NCT06028048 | Unknown Phase 2 DMC

• 1 other identifier: 24535
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer Survivors; Return to Work

Keywords

Cancer survivors; Return to Work; Reintegration; Unemployment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Employment status

  Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)

• Time until paid employment

  Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)

• Change in working hours

  Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)

• Importance of work

  Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)

• RTW expectations

  Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)

Study Arms (2)

PLACES intervention

EXPERIMENTAL

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

Behavioral: PLACES

Care as usual

NO INTERVENTION

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

Interventions

PLACES 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.

Also known as: Individual Placement and Support (IPS), Supported employment

PLACES intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (2)

UWV

Haarlem, Netherlands

RECRUITING

UWV Zaandam

Zaandam, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 39252084 DERIVED

MeSH Terms

Interventions

Palliative Care; Employment, Supported

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Employment; Socioeconomic Factors; Population Characteristics; Rehabilitation, Vocational; Rehabilitation

Central Study Contacts

Fenna van Ommen, Msc.

CONTACT

+31613812892; f.vanommen1@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The analyses will be performed blinded after one researcher codes the intervention and control group to either 0 or 1.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. Angela de Boer, Professor in Chronic Disease and Work Participation at the Faculty of Medicine at Amsterdam UMC.

Model Details: 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 .

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

NL (2)