CancerSEAMLESSNCT05470010
Smartphone App-Based Mindfulness Intervention for French and English Speaker Cancer Survivors
A study testing Mindfulness in people with Cancer and Psychological, run by Canadian Cancer Trials Group at 7 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Psychological
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 7 sitesCanada
- Study dates
- 7 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Western Manitoba Cancer Centre
Brandon, Manitoba, R7A 2B3
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Horizon Health Network
Fredericton, New Brunswick, E3B 5N5
BCCA - Kelowna
Kelowna, British Columbia, V1Y 5L3
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
BCCA - Prince George
Prince George, British Columbia, V2M 7E9
BCCA - Victoria
Victoria, British Columbia, V8R 6V5
About this study
Official title: 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).
Read the 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.
- Conditions
- Cancer, Psychological
- Being tested
- Mindfulness
- Keywords
- Cancer survivors, Smartphone app, Mindfulness
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 1 month after randomization
Patient Reported Outcome Measurement Information System (PROMIS) - Anxiety
Short form (4 items). A higher score indicates higher levels of anxiety.
Measured: 3 months
Patient Reported Outcome Measurement Information System (PROMIS) - Depression
Short form (4 items). A higher score indicates higher levels of depression.
Measured: 3 months
Patient Reported Outcome Measurement Information System (PROMIS) - Fatigue
Short form (4 items). A higher score indicates higher levels of fatigue.
Measured: 3 months
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.
Measured: 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).
Measured: 3 months
App-based User Data - Perceived Stress
Perceived stress will be measured using a stress slider within the app.
Measured: 3 months
App-based User Data - Mood
Mood will be measured using a mood board.
Measured: 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".
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start7 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Linda E Carlson, Study chair, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470010
- Sponsor's protocol ID
- SC28
- Acronym
- SEAMLESS
- Status last verified
- Jul 2026
- First submitted
- 19 May 2022
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05470010
- Acronym / sponsor ID
- SEAMLESS / SC28
- Conditions
- Cancer, Psychological
- Keywords
- Cancer survivors, Smartphone app, Mindfulness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Mindfulness | Experimental | Behavioral: MindfulnessA 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. |
| Control Mindfulness | Other | Behavioral: MindfulnessNo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindfulnessA 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. | Behavioural | Control Mindfulness, Immediate Mindfulness |
Primary outcome
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.
9 secondary outcomes
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
Patient Reported Outcome Measurement Information System (PROMIS) - Anxiety
Time frame: 3 months
Patient Reported Outcome Measurement Information System (PROMIS) - Depression
Time frame: 3 months
Patient Reported Outcome Measurement Information System (PROMIS) - Fatigue
Time frame: 3 months
Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function
Time frame: 3 months
Quality of Life - European Organization for Research and Treatment of Cancer quality of life
Time frame: 3 months
App-based User Data - Perceived Stress
Time frame: 3 months
App-based User Data - Mood
Time frame: 3 months
App-based User Data - Objective Stress
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda E Carlson study chair
University of Calgary
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in people with Cancer and Psychological, run by Canadian Cancer Trials Group at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calgary Symptoms of Stress Inventory (C-SOSI) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.