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

March 24, 2026 updated by: Canadian Cancer Trials Group

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
345

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Calgary Symptoms of Stress Inventory (C-SOSI)
Time Frame: 3 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
Perceived stress will be measured using a stress slider within the app.
3 months
App-based User Data - Mood
Time Frame: 3 months
Mood will be measured using a mood board.
3 months
App-based User Data - Objective Stress
Time Frame: 3 months
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
Time Frame: 3 months
Short form (4 items). A higher score indicates higher levels of anxiety.
3 months
Patient Reported Outcome Measurement Information System (PROMIS) - Depression
Time Frame: 3 months
Short form (4 items). A higher score indicates higher levels of depression.
3 months
Patient Reported Outcome Measurement Information System (PROMIS) - Fatigue
Time Frame: 3 months
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
Time Frame: 1 month after 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Canadian Cancer Trials Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Linda E Carlson, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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