iCanWork: A Randomized Controlled Trial (iCanWork)
22 de septiembre de 2022 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
270
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Quebec
-
Montréal, Quebec, Canadá, H3A 0G4
- McGill University
-
Contacto:
- Christine Maheu, PhD
- Número de teléfono: 514-398-1906
- Correo electrónico: christine.maheu@mcgill.ca
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
Participants will receive RTW support from the VRC and OT.
|
|
Sin intervención: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline return to work status in the course of the 24-month study
Periodo de tiempo: baseline, 6 months, 12 months, 18 months, 24 months
|
binary variable (Yes/No)
|
baseline, 6 months, 12 months, 18 months, 24 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline health related quality of life in the course of the 24-month study
Periodo de tiempo: 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.
|
baseline, 6 months, 12 months, 18 months, 24 months
|
|
Change from baseline readiness to return to work in the course of the 24-month study
Periodo de tiempo: baseline, 6 months, 12 months, 18 months, 24 months
|
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.
|
baseline, 6 months, 12 months, 18 months, 24 months
|
|
Change from baseline work capacity in the course of the 24-month study
Periodo de tiempo: baseline, 6 months, 12 months, 18 months, 24 months
|
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.
|
baseline, 6 months, 12 months, 18 months, 24 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de abril de 2023
Finalización primaria (Anticipado)
1 de septiembre de 2025
Finalización del estudio (Anticipado)
1 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
15 de septiembre de 2022
Primero enviado que cumplió con los criterios de control de calidad
19 de septiembre de 2022
Publicado por primera vez (Actual)
21 de septiembre de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de septiembre de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
22 de septiembre de 2022
Última verificación
1 de septiembre de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- iCanWork_CIHR
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Study Protocol will be published with an open access peer-reviewed journal
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .