Smartphone mindfulness program for English- and French-speaking cancer survivors
The SEAMLESS Study: A Pragmatic Multi-Site Randomized Waitlist-Controlled Trial of a Smartphone App-Based Mindfulness Intervention for French and English Speaker Cancer Survivors
This project will test a 4-week smartphone mindfulness app to see if it reduces stress and other symptoms in cancer survivors who have finished primary treatment and speak English or French.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 345 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Canadian Cancer Trials Group Research network |
| Drugs / interventions | trastuzumab, chemotherapy, radiation |
| Locations | 7 sites (Calgary, Alberta and 6 other locations) |
| Trial ID | NCT05470010 on ClinicalTrials.gov |
What this trial studies
This is a randomized wait-list controlled trial testing the MBCS Journey app, a mobile version of the Mindfulness-Based Cancer Recovery program delivered through the AM app. The app offers lessons, personalized guided-meditation playlists, an emotion-mapping board, and facial bio-signal analysis to tailor practices. Adults who completed primary cancer treatment at least 2 weeks prior will be randomized to start the 4-week intervention immediately or after a 3-month wait. Primary outcome is stress with secondary outcomes including anxiety, depression, and fatigue, and all participation requires smartphone and internet access.
Who should consider this trial
Good fit: Adults (≥18) who completed primary cancer treatment at least 2 weeks ago, are fluent in English or French, have a smartphone with internet access, and can commit about 20–30 minutes daily for four weeks.
Not a fit: Patients without smartphone access, those unable to use mobile apps, or those needing immediate in-person psychiatric care may not receive benefit from this app-based intervention.
Why it matters
Potential benefit: If successful, this could provide survivors an easy, low-cost way to reduce stress, anxiety, and fatigue from home.
How similar studies have performed: In-person mindfulness programs for cancer survivors have shown benefit and early studies of mindfulness apps show promising but limited evidence, so this mobile approach builds on existing but still-emerging data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Calgary, Alberta and 6 other locations
- Arthur J.E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada (Recruiting)
- BCCA - Kelowna — Kelowna, British Columbia, Canada (Recruiting)
- BCCA - Prince George — Prince George, British Columbia, Canada (Recruiting)
- BCCA - Victoria — Victoria, British Columbia, Canada (Recruiting)
- Western Manitoba Cancer Centre — Brandon, Manitoba, Canada (Recruiting)
- Horizon Health Network — Fredericton, New Brunswick, Canada (Recruiting)
- Kingston Health Sciences Centre — Kingston, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Harriet Richardson
- Email: hrichardson@ctg.queensu.ca
- Phone: 613-533-6430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.