iCanWork: A Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMcGill University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • iCanWork Intervention

    Behavioral

    Participants will receive RTW support from the VRC and OT.

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: iCanWork InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

binary variable (Yes/No)

Time frame
baseline, 6 months, 12 months, 18 months, 24 months

Secondary outcomes

1

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

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.

Time frame
baseline, 6 months, 12 months, 18 months, 24 months
2

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

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.

Time frame
baseline, 6 months, 12 months, 18 months, 24 months
3

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

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.

Time frame
baseline, 6 months, 12 months, 18 months, 24 months

Other outcomes

Sponsors and contacts

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