iCanWork: A Randomized Controlled Trial (iCanWork)
22 september 2022 bijgewerkt door: Christine Maheu, McGill University
Effects of the iCanWork Intervention to Improve Cancer Survivors' Experience With Return to Work: A Randomized Controlled Trial (RCT)
The aim of this study is to evaluate the effectiveness of the iCanWork intervention in assisting cancer survivors (CS) to return to work (RTW) and its impact on their health-related quality of life (QoL), health service utilization, RTW readiness, time to RTW, and work capacity.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Gedetailleerde beschrijving
The iCanWork intervention comprises several elements related to health and work, taken from the latest reviews that recommend a remote and individual intervention, led by a vocational rehabilitation counsellor (VRC), experts in assisting RTW for CS.
The intervention includes 6 sessions with a VRC and 1-4 sessions with an occupational therapist (OT).
A total of 270 CS will be recruited into 2 groups (intervention or control).
The duration of this study is 24 months.
Study participants will complete electronic questionnaires measuring study variables at baseline before randomization and at 6-month, 12-month, 18-month, and 24-month follow-ups.
Studietype
Ingrijpend
Inschrijving (Verwacht)
270
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Quebec
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Montréal, Quebec, Canada, H3A 0G4
- McGill University
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Contact:
- Christine Maheu, PhD
- Telefoonnummer: 514-398-1906
- E-mail: christine.maheu@mcgill.ca
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- diagnosed with cancer (all types) treated with curative intent and of working age (between 18 and 65 at the time of diagnosis)
- gainfully employed at the time of diagnosis (full or part-time, including students)
- still on sick leave, including long-term disability leave, but for less than 2 years
- has not started to return to work, since stopping due to cancer
- can read and understand English or French
- reside in Canada.
Exclusion Criteria:
- If the cancer survivor's physicians consider returning to work unwise, such as due to a metastatic cancer diagnosis
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: iCanWork Intervention
iCanWork includes 6 1-hour sessions with a VRC and 1 to 4 1-hour sessions with an OT.
In the positive event that a participant has returned to work during the study, three of the six VRC sessions are reserved to support the participants in their transition to the workplace.
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Participants will receive RTW support from the VRC and OT.
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Geen tussenkomst: Control
Participants randomized to the control group will receive their usual care and will be referred to the Cancer Work website for educational resources related to RTW.
If they contact the team with RTW-related questions, they will be referred to their care teams.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from baseline return to work status in the course of the 24-month study
Tijdsspanne: baseline, 6 months, 12 months, 18 months, 24 months
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binary variable (Yes/No)
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baseline, 6 months, 12 months, 18 months, 24 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from baseline health related quality of life in the course of the 24-month study
Tijdsspanne: baseline, 6 months, 12 months, 18 months, 24 months
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The Patient Reported Outcome Information System (PROMIS) - Preference scale is a valid, 31-item tool to measure 7 domains of quality of life (i.e., cognition, depression, fatigue, pain, physical function, sleep disturbance, and ability to participate in social roles and activities).
Each of these items is measured on five levels (e.g., "never", "rarely", "sometimes", "often", "always" or "not at all", "a little bit", "somewhat", "quite a bit", and "very much").
The responses (1 to 5 on a Likert scale) were transformed into PROMIS theta scores (mean = 0 ± SD = 1) or T-Scores (mean = 50 ± SD = 10).
For cognition, physical function, and ability to participate in social roles and activities, higher T-Scores (thetas) indicate more desirable outcomes.
For depression, fatigue, pain, and sleep disturbance, lower T-Scores (thetas) indicate more desirable outcomes.
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baseline, 6 months, 12 months, 18 months, 24 months
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Change from baseline readiness to return to work in the course of the 24-month study
Tijdsspanne: baseline, 6 months, 12 months, 18 months, 24 months
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The Readiness for Return-To-Work Scale is a validated 22-item measure of the readiness to return to work stages and consists of two scales; Scale A contains 13 items for individuals who are not working and Scale B includes 9 items for individuals who are working either part or full time.
Each item is scored using a 5 point scale (1 = strongly disagree, 5 = strongly agree) representing a specific readiness stage: Pre-contemplation; Contemplation; Prepared for Action-Self-evaluative; and Prepared for Action-Behavioural for those not back at work and Uncertain Maintenance or Proactive Maintenance for those who are currently working.
The scale provides a final score for each readiness stage by taking the mean of the items that create that factor.
Higher scores associated with a readiness stage indicate higher level of beliefs associated with that stage.
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baseline, 6 months, 12 months, 18 months, 24 months
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Change from baseline work capacity in the course of the 24-month study
Tijdsspanne: baseline, 6 months, 12 months, 18 months, 24 months
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Work capacity will be measured with the 7-item validated Work Capacity Index which measures seven domains related to the level of work capacity namely: 1) current work capacity compared to pre-cancer work capacity; 2) current work capacity compared to job demands; 3) number of physician-diagnosed health problems; 4) work disability due to illnesses; 5) days of absenteeism since stopping work due to cancer; 6) prognosis of anticipated work capacity for the next two years; and 7) psychological resources.
The score of the 7 domains is summed ranging from 7 to 49 with a higher score indicating a greater capacity for work.
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baseline, 6 months, 12 months, 18 months, 24 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Verwacht)
1 april 2023
Primaire voltooiing (Verwacht)
1 september 2025
Studie voltooiing (Verwacht)
1 september 2026
Studieregistratiedata
Eerst ingediend
15 september 2022
Eerst ingediend dat voldeed aan de QC-criteria
19 september 2022
Eerst geplaatst (Werkelijk)
21 september 2022
Updates van studierecords
Laatste update geplaatst (Werkelijk)
26 september 2022
Laatste update ingediend die voldeed aan QC-criteria
22 september 2022
Laatst geverifieerd
1 september 2022
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- iCanWork_CIHR
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Study Protocol will be published with an open access peer-reviewed journal
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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