iCanWork: A Randomized Controlled Trial

NCT05546736 | Not Yet Recruiting

• 1 other identifier: iCanWork_CIHR
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer-related Problem/Condition; Survivorship; Quality of Life

Keywords

return to work; cancer survivors; vocational rehabilitation; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change from baseline return to work status in the course of the 24-month study

  binary variable (Yes/No)

  baseline, 6 months, 12 months, 18 months, 24 months

Secondary Outcomes (3)

• Change from baseline health related quality of life in the course of the 24-month study

  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

  baseline, 6 months, 12 months, 18 months, 24 months

• Change from baseline work capacity in the course of the 24-month study

  baseline, 6 months, 12 months, 18 months, 24 months

Study Arms (2)

iCanWork Intervention

EXPERIMENTAL

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.

Behavioral: iCanWork Intervention

Control

NO INTERVENTION

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.

Interventions

iCanWork Intervention BEHAVIORAL

Participants will receive RTW support from the VRC and OT.

iCanWork Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- If the cancer survivor's physicians consider returning to work unwise, such as due to a metastatic cancer diagnosis

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

McGill University

Montreal, Quebec, H3A 0G4, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 21, 2022
• Study Start: April 1, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CA (1)