Smartphone App-Based Mindfulness Intervention for French and English Speaker Cancer Survivors (NCT05470010) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Smartphone App-Based Mindfulness Intervention for French and English Speaker Cancer Survivors
Canada300 participantsStarted 2025-03-07
Plain-language summary
There is a need to develop, evaluate, and disseminate self-directed, easily accessible, safe, affordable, and effective psychosocial interventions to people living with cancer (PLWC) post-treatment. Smartphone app-based health interventions are an innovative way to deliver psychosocial cancer-care. The Mindfulness-Based Cancer Survivorship (MBCS) Journey app is a mobile app format of the Mindfulness-based Cancer Recovery program. In the SEAMLESS Study, the investigators aim to evaluate the MBCS Journey app (a 4 week mind-body intervention) in cancer survivors post-treatment. This is a randomized wait-list controlled trial. Participants will either be assigned into the immediate group (will receive intervention immediately after enrollment) or the waitlist group (wait for 3 months before receiving the intervention).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult ≥ 18 years
* Diagnosed with any type of cancer (stages I-IV)
* Completed primary treatment (i.e. surgery, chemotherapy, radiation therapy) at least 2 weeks (14days) prior. Note: ongoing maintenance therapy, hormone-blocking therapies, intermittent bone-modifying agents, herceptin and targeted therapy with trastuzumab are not exclusionary.
* Have access to a smartphone with data or wifi connection.
* Willing to devote 20-30 mins of time to mindfulness practices daily during the 4-week intervention period.
* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form (e-consent) prior to enrollment in the study to document their willingness to participate.
* Participant is able (i.e. sufficiently fluent) and willing to complete the MBCS Journey and outcome measures in either English or French. The baseline assessment must be completed within required timelines, prior to randomization.
* In accordance with CCTG policy, protocol intervention is intended to begin within 7 calendar days of patient randomization.
* Participants must be willing to complete the MBCS Journey and complete the follow-up questionnaires
Exclusion Criteria:
* Major communication difficulties at the time of recruitment, as assessed by the research team (e.g. severe hearing impairment or cognitive impairment (score of ≤ 6; as assessed by the centre CRA using the three questions from…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.