NCT05470010 Smartphone App-Based Mindfulness Intervention for French and English Speaker Cancer Survivors
| NCT ID | NCT05470010 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Canadian Cancer Trials Group |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 345 participants |
| Start Date | 2025-03-07 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 345 participants in total. It began in 2025-03-07 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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 the Brief Screen for Cognitive Impairment (BSCI)) listed in the screening CRF, which could interfere with completing the intervention and/or the questionnaires (i.e. inability to read or write) * Suffering from untreated Major Depressive Disorder or other psychiatric disorders that would interfere with participation. (Note: Participants will be referred for treatment and invited to call back once in remission). * Previous experience practicing in-person or app-based mindfulness once a week or more within the last year.
Contact & Investigator
Linda E Carlson
STUDY CHAIR
University of Calgary
Frequently Asked Questions
Who can join the NCT05470010 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05470010 currently recruiting?
Yes, NCT05470010 is actively recruiting participants. Contact the research team at hrichardson@ctg.queensu.ca for enrollment information.
Where is the NCT05470010 trial being conducted?
This trial is being conducted at Calgary, Canada, Kelowna, Canada, Prince George, Canada, Victoria, Canada and 3 additional locations.
Who is sponsoring the NCT05470010 clinical trial?
NCT05470010 is sponsored by Canadian Cancer Trials Group. The principal investigator is Linda E Carlson at University of Calgary. The trial plans to enroll 345 participants.
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