iCanWork: A Randomized Controlled Trial (iCanWork)
22. september 2022 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Forventet)
270
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Quebec
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Montréal, Quebec, Canada, H3A 0G4
- McGill University
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Ta kontakt med:
- Christine Maheu, PhD
- Telefonnummer: 514-398-1906
- E-post: christine.maheu@mcgill.ca
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
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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
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. april 2023
Primær fullføring (Forventet)
1. september 2025
Studiet fullført (Forventet)
1. september 2026
Datoer for studieregistrering
Først innsendt
15. september 2022
Først innsendt som oppfylte QC-kriteriene
19. september 2022
Først lagt ut (Faktiske)
21. september 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. september 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. september 2022
Sist bekreftet
1. september 2022
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- iCanWork_CIHR
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Study Protocol will be published with an open access peer-reviewed journal
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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