CancerNCT03557762
The SEAMLESS Study: Smartphone App-based Mindfulness for Cancer Survivors
A study testing Mindfulness in people with Cancer and Psychological, run by University of Calgary at 1 site in Canada.
Trial summary
Smartphone app-based health interventions are an innovative way to deliver psychosocial cancer-care. In the SEAMLESS study, the investigators aim to evaluate a 4 week smartphone app-based mind-body intervention (MBI) in cancer survivors post-treatment. 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
- 83 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jan 2019to 6 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men and women over the age of 18
- Diagnosed with any type of cancer (stage I-III)
- Completed active treatment (i.e. surgery, chemotherapy, radiation therapy) at least 4 months previously (ongoing hormonal therapies, AIs, tamoxifen, herceptin are not exclusionary)
- Have access to a smartphone with data connection; in case patients' do not have a data plan or an insufficient data plan with their smart phone, we will pay for their data connection (up to 0.5GB/month)
- Willing to devote 20-30 mins of time to do the mindfulness meditations and practices every day
- Sufficient cognitive function to participate in the smartphone app-based intervention
- Ability to speak and write English sufficiently to complete questionnaires
Who cannot join
- Metastatic patients and those with ongoing chemotherapy (metastatic patients may not be stable enough to participate in the interventions and follow-up assessments).
- Cognitive impairment that would interfere with completing questionnaires or the intervention.
- Suffering from current Major Depressive Disorder, Bipolar Disorder or other psychiatric disorder that would interfere with the ability to participate.
- Practicing smartphone app-based mindfulness more than or equal to once a week
Trial locations and contacts
1 site in 1 country.
Canada1 site
Psychosocial Oncology, Cancer Control Alberta
Calgary, Alberta, T2N 3C1
About this study
Official title: The SEAMLESS Study: A Clinical Trial Evaluation of a SmartphonE App-based MindfuLnEss Intervention for Cancer SurvivorS
Smartphone app-based health interventions are an innovative way to deliver psychosocial cancer-care. In the SEAMLESS study, the investigators aim to evaluate a 4 week smartphone app-based mind-body intervention (MBI) in cancer survivors post-treatment. This is a randomized controlled trial, with a waitlist control group. Participants will be assigned to either receive the intervention immediately after enrollment or will need to wait for 3 months to receive the intervention.
Read the detailed description
BACKGROUND Cancer patients who are in the transition phase to survivorship after completing their final treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurrence. Smartphone app-based health interventions are an innovative way to deliver psychosocial cancer-care. In the SEAMLESS study, the investigators aim to evaluate an app-based mind-body intervention (MBI) in cancer survivors.
The need for psychosocial interventions for cancer survivors has been highlighted by the Institute of Medicine in their landmark survivorship report appropriately titled, "Lost in Transition." Cancer survivors are often unable to participate in face-to-face interventions because of difficulties such as compromised immunity, treatment-related side-effects, scheduling conflicts and geography. A smartphone-app based MBI can overcome several such difficulties, since patients can participate at their own convenience without the burden of travel and scheduling classes.
INTERVENTION DESIGN The AM smartphone app supports personalized mindfulness practices through lessons and personalized guided-meditation playlists; AM reportedly reduced anxiety in a study with college students. AM interprets 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 is a randomized wait-list controlled trial, which will evaluate AM's effectiveness for reducing stress (primary outcome), anxiety, depression, fatigue and fear of cancer recurrence in cancer survivors who have completed all treatments for 2 weeks or more. Outcomes will be assessed online using validated PROMIS measures at 1) baseline, 2) mid-point 3) immediately post-intervention, 4\&5) 3 and 6 months follow-up post-baseline.
SIGNIFICANCE Cancer-care providers are uncertain about the efficacy of app-based interventions for patients, which are available in great supply in today's digital world. This study will provide rigorously evaluated efficacy data for an app-based MBI 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 every day, with a minimum of 4 days of activity in a week. Receives: Behavioral: Mindfulness |
| Waitlist Control Mindfulness | Other | No intervention 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.
Symptoms of Stress
Calgary - Symptoms of Stress Inventory (C-SOSI)
Measured: 3 months
Secondary outcomes (6)
Fear of Cancer Recurrence
Fear of Cancer Recurrence Inventory (FCRI)
Measured: 3 months
Anxiety - PROMIS
PROMIS- Cancer Bank v1.0 - Anxiety
Measured: 3 months
Depression - PROMIS
PROMIS- Cancer Bank v1.0 - Depression
Measured: 3 months
Fatigue - PROMIS
PROMIS- Cancer Bank v1.0 - Fatigue
Measured: 3 months
Physical Function - PROMIS
PROMIS- Cancer Bank v1.1 - Physical Function
Measured: 3 months
App-based User Data
Users' self-reported stress, biometrics and engagement
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 posted15 Jun 2018
- Study start25 Jan 2019
- Primary completion6 Jan 2020
- Study completion6 Aug 2020
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 University of CalgaryThe 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda E. Carlson, University of Calgary
- Investigators
- Linda Carlson, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557762
- Sponsor's protocol ID
- HREBA.CC-18-0029
- Status last verified
- May 2022
- First submitted
- 4 Jun 2018
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SEAMLESS Study: A Clinical Trial Evaluation of a SmartphonE App-based MindfuLnEss Intervention for Cancer SurvivorS
- ClinicalTrials.gov ID
- NCT03557762
- Acronym / sponsor ID
- HREBA.CC-18-0029
- Conditions
- Cancer, Psychological
- Keywords
- Cancer survivors, Smartphone app, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 6 Aug 2020 (actual)
- First posted
- 15 Jun 2018 (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.
Smartphone app-based health interventions are an innovative way to deliver psychosocial cancer-care. In the SEAMLESS study, the investigators aim to evaluate a 4 week smartphone app-based mind-body intervention (MBI) in cancer survivors post-treatment. This is a randomized controlled trial, with a waitlist control group. Participants will be assigned to either receive the intervention immediately after enrollment or will need to wait for 3 months to receive the intervention.
Detailed description
BACKGROUND Cancer patients who are in the transition phase to survivorship after completing their final treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurrence. Smartphone app-based health interventions are an innovative way to deliver psychosocial cancer-care. In the SEAMLESS study, the investigators aim to evaluate an app-based mind-body intervention (MBI) in cancer survivors.
The need for psychosocial interventions for cancer survivors has been highlighted by the Institute of Medicine in their landmark survivorship report appropriately titled, "Lost in Transition." Cancer survivors are often unable to participate in face-to-face interventions because of difficulties such as compromised immunity, treatment-related side-effects, scheduling conflicts and geography. A smartphone-app based MBI can overcome several such difficulties, since patients can participate at their own convenience without the burden of travel and scheduling classes.
INTERVENTION DESIGN The AM smartphone app supports personalized mindfulness practices through lessons and personalized guided-meditation playlists; AM reportedly reduced anxiety in a study with college students. AM interprets 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 is a randomized wait-list controlled trial, which will evaluate AM's effectiveness for reducing stress (primary outcome), anxiety, depression, fatigue and fear of cancer recurrence in cancer survivors who have completed all treatments for 2 weeks or more. Outcomes will be assessed online using validated PROMIS measures at 1) baseline, 2) mid-point 3) immediately post-intervention, 4\&5) 3 and 6 months follow-up post-baseline.
SIGNIFICANCE Cancer-care providers are uncertain about the efficacy of app-based interventions for patients, which are available in great supply in today's digital world. This study will provide rigorously evaluated efficacy data for an app-based MBI 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 every day, with a minimum of 4 days of activity in a week. |
| Waitlist Control Mindfulness | Other | Behavioral: MindfulnessNo intervention 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 (7 listed)
- Men and women over the age of 18
- Diagnosed with any type of cancer (stage I-III)
- Completed active treatment (i.e. surgery, chemotherapy, radiation therapy) at least 4 months previously (ongoing hormonal therapies, AIs, tamoxifen, herceptin are not exclusionary)
- Have access to a smartphone with data connection; in case patients' do not have a data plan or an insufficient data plan with their smart phone, we will pay for their data connection (up to 0.5GB/month)
- Willing to devote 20-30 mins of time to do the mindfulness meditations and practices every day
Key exclusion criteria (4 listed)
- Metastatic patients and those with ongoing chemotherapy (metastatic patients may not be stable enough to participate in the interventions and follow-up assessments).
- Cognitive impairment that would interfere with completing questionnaires or the intervention.
- Suffering from current Major Depressive Disorder, Bipolar Disorder or other psychiatric disorder that would interfere with the ability to participate.
- Practicing smartphone app-based mindfulness more than or equal to once a week
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 | Immediate Mindfulness, Waitlist Control Mindfulness |
Primary outcome
Symptoms of Stress
Time frame: 3 months
Calgary - Symptoms of Stress Inventory (C-SOSI)
6 secondary outcomes
Fear of Cancer Recurrence
Time frame: 3 months
Anxiety - PROMIS
Time frame: 3 months
Depression - PROMIS
Time frame: 3 months
Fatigue - PROMIS
Time frame: 3 months
Physical Function - PROMIS
Time frame: 3 months
App-based User Data
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No. No plan to share IPD
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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 Carlson, PhD principal investigator
University of Calgary
1 site 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 University of Calgary at 1 site 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Symptoms of Stress (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 23 May 2022.