Mindfulness App for Cancer Survivors

(SEAMLESS Trial)

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Canadian Cancer Trials Group

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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).

Research Team

Linda E Carlson

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for English or French-speaking cancer survivors over 18 who've finished primary treatment at least 2 weeks ago. They must be willing to practice mindfulness daily using an app and have a smartphone with internet. It's not for those with cognitive impairments, weekly mindfulness experience, or current major depression.

Inclusion Criteria

I am 18 years old or older.

I finished my main cancer treatment at least 2 weeks ago.

Have access to a smartphone with data or wifi connection

Exclusion Criteria

I have untreated depression or other mental health issues that could affect my participation.

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; assessed using three questions from the Brief Screen for Cognitive Impairment (BSCI)), which could interfere with completing the intervention and/or the questionnaires (i.e. inability to read or write)

Previous experience practicing in-person or app-based mindfulness once a week or more within the last year

Treatment Details

Interventions

• Mindfulness (Behavioral Intervention)

Trial Overview The study tests the 'MBCS Journey' app, a mobile version of Mindfulness-based Cancer Recovery program. Participants are randomly placed in two groups: one starts immediately, while the other waits three months before beginning the four-week mind-body intervention.

Participant Groups

Group I: Immediate Mindfulness Experimental Treatment 1 Intervention

A 4 week smartphone app-based mindfulness intervention program with in-app activities for 20-30 minutes everyday, with a minimum of 4 days of activity in a week.

Group II: Control Mindfulness Experimental Treatment 1 Intervention

No intervention and usual care for 4 weeks, after which there will be assessments immediately post-waiting and at 3 months post-baseline. After this, participants will get the same 4 week smartphone app-based mindfulness intervention program.

Mindfulness is already approved in Canada for the following indications:

Approved in Canada as Mindfulness-Based Cognitive Therapy for:

• Depression
• Anxiety Disorders
• Substance Abuse Treatment

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+