AzTrials
AzTrials

Cancer SurvivorsPhase 2/3PLACESNCT06028048

Enhancing Work Participation of Unemployed and Work-Disabled Cancer Survivors

A Phase 2/3 study testing PLACES in people with Cancer Survivors and Return to Work, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Cancer Survivors, Return to Work
What is being tested?
PLACES
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
2 sitesNetherlands
Study dates
1 Sep 2023to 1 Sep 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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 locations and contacts

2 sites in 1 country.

Fenna van Ommen, Msc. contact

+31613812892

f.vanommen1@amsterdamumc.nl

Netherlands2 sites, 2 recruiting

  • UWV

    Haarlem

    Wim Buijs

    Recruiting

  • UWV Zaandam

    Zaandam

    Imke Odé

    Recruiting

Other trials in Netherlands

About this study

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

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:

Read more
  • 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.

Read the 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)

Being tested
PLACES
Keywords
Cancer survivors, Return to Work, Reintegration, Unemployment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PLACESBehavioural

    Also called Individual Placement and Support (IPS), Supported employment

    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.

Study groups in NCT06028048
Study groupRoleWhat they receive
PLACES interventionExperimentalParticipants in the intervention group will receive the PLACES intervention during 12-months after randomization.
Receives: Behavioral: PLACES
Care as usualNo interventionParticipants in the control group will receive usual care from the SSA.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (9)

  1. 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'.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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).

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

  6. 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)

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2023
  2. Study start1 Sep 2023
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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 .
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
164 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06028048
Sponsor's protocol ID
24535
Acronym
PLACES
Status last verified
Sep 2023
First submitted
31 Aug 2023
Last updated
29 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Questionnaire data will be gathered via Castor EDC (GCP-approved). Amsterdam UMC, location AMC has a processor agreement with Castor EDC: AMC Intranet - Castor EDC. All quantitative data will be stored in Access and SPSS databases. Data will be handled confidentially. Participants' personal data will be pseudonymized by means of codes that do not contain any identifiable information. A participant identification code list will be used to link the data to the participants. The key to the code list will be stored separately from the pseudonymized dataset. The code list will be stored in a locked storage area in the work office and safeguarded by the project leader. Only authorized members of the research team will have access to the key. The pseudonymized dataset will be stored on a secured Amsterdam UMC location AMC server, and safeguarded by authorized members of the research team, for 15 years.

Publications

  • 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.

    PubMed 39252084

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing PLACES in people with Cancer Survivors and Return to Work, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fenna van Ommen, Msc. (+31613812892, f.vanommen1@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Paid employment (yes/no) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06028048, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in