AzTrials
AzTrials

Cancer-related Problem/ConditioniCanWorkNCT05546736

iCanWork: A Randomized Controlled Trial

A study testing iCanWork Intervention in people with Cancer-related Problem/Condition and Survivorship, run by McGill University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
iCanWork Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
1 siteCanada
Study dates
1 Apr 2023to 1 Sep 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McGill University

    Montreal, Quebec, H3A 0G4

    Christine Maheu, PhD, 514-398-1906, christine.maheu@mcgill.ca

Other trials in Canada

About this study

Official title: 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.

Read the detailed description

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.

Being tested
iCanWork Intervention
Keywords
return to work, cancer survivors, vocational rehabilitation, randomized controlled trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iCanWork InterventionBehavioural

    Participants will receive RTW support from the VRC and OT.

Study groups in NCT05546736
Study groupRoleWhat they receive
iCanWork InterventionExperimentaliCanWork 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.
Receives: Behavioral: iCanWork Intervention
ControlNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    binary variable (Yes/No)

    Measured: baseline, 6 months, 12 months, 18 months, 24 months

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: 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.

    Measured: baseline, 6 months, 12 months, 18 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2022
  2. Study start1 Apr 2023 (estimated)
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05546736
Sponsor's protocol ID
iCanWork_CIHR
Acronym
iCanWork
Status last verified
Sep 2022
First submitted
15 Sep 2022
Last updated
26 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study Protocol will be published with an open access peer-reviewed journal

Questions about this trial

What is this clinical trial studying?

A study testing iCanWork Intervention in people with Cancer-related Problem/Condition and Survivorship, run by McGill University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline return to work status in the course of the 24-month study (time frame: baseline, 6 months, 12 months, 18 months, 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05546736.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in