The SEAMLESS Study: Smartphone App-based Mindfulness for Cancer Survivors
NCT ID: NCT03557762
Last Updated: 2022-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
83 participants
INTERVENTIONAL
2019-01-25
2020-08-06
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Immediate Mindfulness
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.
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.
Waitlist Control Mindfulness
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with any type of cancer (stage I-III)
3. Completed active treatment (i.e. surgery, chemotherapy, radiation therapy) at least 4 months previously (ongoing hormonal therapies, AIs, tamoxifen, herceptin are not exclusionary)
4. 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)
5. Willing to devote 20-30 mins of time to do the mindfulness meditations and practices every day
6. Sufficient cognitive function to participate in the smartphone app-based intervention
7. Ability to speak and write English sufficiently to complete questionnaires
Exclusion Criteria
2. Cognitive impairment that would interfere with completing questionnaires or the intervention.
3. Suffering from current Major Depressive Disorder, Bipolar Disorder or other psychiatric disorder that would interfere with the ability to participate.
4. Practicing smartphone app-based mindfulness more than or equal to once a week
18 Years
ALL
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Linda E. Carlson
Enbridge Research Chair in Psychosocial Oncology
Principal Investigators
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Linda Carlson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Psychosocial Oncology, Cancer Control Alberta
Calgary, Alberta, Canada
Countries
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Other Identifiers
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HREBA.CC-18-0029
Identifier Type: -
Identifier Source: org_study_id
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