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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Cancer; Psychological
• Intervention / Treatment: Behavioral: Mindfulness

Detailed Description

BACKGROUND: Cancer patients who are transitioning into the survivorship phase after completing their final treatments often have unmet needs that are different than those faced during the diagnosing phase or treatment phase of their journey. PLWC tend to experience late and long-term effects such as pain, fatigue, and distress. They can also experience psychosocial stressors such as anxiety, depression, uncertainty about the future, and the fear of cancer reoccurrence, which can negatively impact their mental health.

Cancer survivors are often unable to receive the face-to-face care they need due to barriers such as compromised immunity, treatment-related side effects, scheduling conflicts, and geography. Having a smartphone app-based mind-body intervention can help patients overcome several of these barriers since they are able to participate in at their own convenience in the comfort of their own home without the burden of travelling to and scheduling these classes.

INTERVENTION DESIGN: The AM smartphone app (where MBCS Journey can be found) supports personalized mindfulness practices through lessons and personalized guided-meditation playlists. The AM app is able to interpret its users' emotional state e.g. angry, elated. from a user-inputted digital emotion-mapping board; and heart-rate data through algorithms that analyze facial bio-signals. The SEAMLESS study aims to evaluate AM's effectiveness for reducing stress (primary outcome), anxiety, depression, fatigue, and overall physical functioning and quality of life (secondary outcome) as well as determining the mechanisms of action. In addition, there are two exploratory objectives: 1) to explore the sex, and gender-based differences in significant outcomes as well as subgroup effects by cancer stage, type, ethnicity, and age and 2) explore the correlation between self-reported stress reduction and app usage and the correlation between stress ratings and psycho-biometric data collected within the app. Outcomes will be assessed using validated Calgary Symptoms of Stress Inventory (for stress), the PROMIS measure (for anxiety, depression, fatigue, and overall physical functioning), and the European Organization for Research and Treatment of Cancer quality of life questionnaire (for quality of life). Assessments will occur at 1) baseline, 2) post-intervention, 3) 3 month after baseline follow-up, and 4) 6 month post-intervention follow-up.

SIGNIFICANCE: In today's digital world, there are many app-based interventions for patients but cancer-care providers are uncertain about their efficacy. Our study will provide rigorously evaluated efficacy data for a smartphone app-based mind-body intervention for cancer survivors, which if helpful, could be made easily available for psychosocial care at cancer centers worldwide.

• Study Type: Interventional
• Enrollment (Estimated): 345
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Harriet Richardson; Phone Number: 613-533-6430; Email: hrichardson@ctg.queensu.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Recruiting
      • Arthur J.E. Child Comprehensive Cancer Centre
      • Contact: Linda Carlson; Phone Number: 587 231-3967
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • Recruiting
      • BCCA - Kelowna
      • Contact: Saroj Niraula; Phone Number: 250 979-6650
    • Prince George, British Columbia, Canada, V2M 7E9
      • Recruiting
      • BCCA - Prince George
      • Contact: Irina Sainchuk; Phone Number: 687482 250 645-7300
    • Victoria, British Columbia, Canada, V8R 6V5
      • Recruiting
      • BCCA - Victoria
      • Contact: Caroline Holloway; Phone Number: 250 519-5609
  • Manitoba
    • Brandon, Manitoba, Canada, R7A 2B3
      • Recruiting
      • Western Manitoba Cancer Centre
      • Contact: William Hunter; Phone Number: 204 578-2208
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 5N5
      • Recruiting
      • Horizon Health Network
      • Contact: M. Saleem Raza; Phone Number: 506 447-4095
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Recruiting
      • Kingston Health Sciences Centre
      • Contact: April Swoboda; Phone Number: 613 544-2361

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Mindfulness; 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; 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.
Other: Control Mindfulness; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function	PROMIS - Cancer Bank v1.1 - Physical Function. This questionnaire has 45 items, each rated on a 5-point Likert scale. A higher score indicates better physical functioning.	3 months
Quality of Life - European Organization for Research and Treatment of Cancer quality of life	European Organization for Research and Treatment of Cancer quality of life - EORTC QLQ C-30. The two items measuring quality of life were used. Each item is rated on a 7-point Likert scale (1-7).	3 months
App-based User Data - Perceived Stress	Perceived stress will be measured using a stress slider within the app.	3 months
App-based User Data - Mood	Mood will be measured using a mood board.	3 months
App-based User Data - Objective Stress	Biometric imaging will be used to measure heart rate and blood flow which combined will predict the participant's "objective stress".	3 months
Patient Reported Outcome Measurement Information System (PROMIS) - Anxiety	Short form (4 items). A higher score indicates higher levels of anxiety.	3 months
Patient Reported Outcome Measurement Information System (PROMIS) - Depression	Short form (4 items). A higher score indicates higher levels of depression.	3 months
Patient Reported Outcome Measurement Information System (PROMIS) - Fatigue	Short form (4 items). A higher score indicates higher levels of fatigue.	3 months
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	The C-SOSI refers to the 56-item Calgary Symptoms of Stress Inventory. There are 8 sub-scales (Depression, Anger, Muscle Tension, Cardiopulmonary Arousal, Sympathetic Arousal, Neurological/GI, Cognitive Disorganization, and Upper Respiratory symptoms) plus a TOTAL stress score.	1 month after randomization

Collaborators and Investigators

• Sponsor: Canadian Cancer Trials Group
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Study Chair: Linda E Carlson, University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Mindfulness; Cancer survivors; Smartphone app
• Additional Relevant MeSH Terms: Neoplasms; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness
• Other Study ID Numbers: SC28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As per CCTG policy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No