iCanWork: A Randomized Controlled Trial (iCanWork)
22. september 2022 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
270
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Quebec
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Montréal, Quebec, Canada, H3A 0G4
- McGill University
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Kontakt:
- Christine Maheu, PhD
- Telefonnummer: 514-398-1906
- E-mail: christine.maheu@mcgill.ca
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Ingen indgriben: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline return to work status in the course of the 24-month study
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline health related quality of life in the course of the 24-month study
Tidsramme: baseline, 6 months, 12 months, 18 months, 24 months
|
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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. april 2023
Primær færdiggørelse (Forventet)
1. september 2025
Studieafslutning (Forventet)
1. september 2026
Datoer for studieregistrering
Først indsendt
15. september 2022
Først indsendt, der opfyldte QC-kriterier
19. september 2022
Først opslået (Faktiske)
21. september 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. september 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. september 2022
Sidst verificeret
1. september 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- iCanWork_CIHR
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Study Protocol will be published with an open access peer-reviewed journal
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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Ingen
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