Smartphone App-Based Mindfulness Intervention for French and English Speaker Cancer Survivors

NCT05470010 | Recruiting DMC

• 1 other identifier: SC28
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 7

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).

Conditions

Cancer; Psychological

Keywords

Cancer survivors; Smartphone app; Mindfulness

Outcome Measures

Primary Outcomes (1)

• Calgary Symptoms of Stress Inventory (C-SOSI)

  This is a 56 item scale. Each item is rated on a 5-point Likert scale (1-5). A higher score indicates higher levels of stress.

  3 months

Secondary Outcomes (9)

• Total symptoms of stress from the C-SOSI to determine the impact of the one-month MBCS Journey intervention on stress immediately after the therapeutic intervention at one month from randomization

  1 month after randomization

• Patient Reported Outcome Measurement Information System (PROMIS) - Anxiety

  3 months

• Patient Reported Outcome Measurement Information System (PROMIS) - Depression

  3 months

• Patient Reported Outcome Measurement Information System (PROMIS) - Fatigue

  3 months

• Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function

  3 months

Study Arms (2)

Immediate Mindfulness

EXPERIMENTAL

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.

Behavioral: Mindfulness

Control Mindfulness

OTHER

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.

Behavioral: Mindfulness

Interventions

Mindfulness BEHAVIORAL

A psychological behavioral intervention that trains participants in mindfulness techniques, which involves achieving a moment-to-moment non-judgmental awareness of their internal psychosocial-emotional state through meditation and gentle mindful movements.

Control Mindfulness; Immediate Mindfulness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ≥ 18 years
• Diagnosed with any type of cancer (stages I-IV)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Cancer Trials Group: lead

Study Sites (7)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

RECRUITING

BCCA - Kelowna

Kelowna, British Columbia, V1Y 5L3, Canada

RECRUITING

BCCA - Prince George

Prince George, British Columbia, V2M 7E9, Canada

RECRUITING

BCCA - Victoria

Victoria, British Columbia, V8R 6V5, Canada

RECRUITING

Western Manitoba Cancer Centre

Brandon, Manitoba, R7A 2B3, Canada

RECRUITING

Horizon Health Network

Fredericton, New Brunswick, E3B 5N5, Canada

RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Linda E Carlson

  University of Calgary

  STUDY CHAIR

Central Study Contacts

Harriet Richardson

CONTACT

613-533-6430; hrichardson@ctg.queensu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: July 22, 2022
• Study Start: March 7, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)