- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03557762
The SEAMLESS Study: Smartphone App-based Mindfulness for Cancer Survivors
The SEAMLESS Study: A Clinical Trial Evaluation of a SmartphonE App-based MindfuLnEss Intervention for Cancer SurvivorS
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 3C1
- Psychosocial Oncology, Cancer Control Alberta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
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 |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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: 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.
|
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 |
---|---|---|
Symptoms of Stress
Time Frame: 3 months
|
Calgary - Symptoms of Stress Inventory (C-SOSI)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fear of Cancer Recurrence
Time Frame: 3 months
|
Fear of Cancer Recurrence Inventory (FCRI)
|
3 months
|
Anxiety - PROMIS
Time Frame: 3 months
|
PROMIS- Cancer Bank v1.0 - Anxiety
|
3 months
|
Depression - PROMIS
Time Frame: 3 months
|
PROMIS- Cancer Bank v1.0 - Depression
|
3 months
|
Fatigue - PROMIS
Time Frame: 3 months
|
PROMIS- Cancer Bank v1.0 - Fatigue
|
3 months
|
Physical Function - PROMIS
Time Frame: 3 months
|
PROMIS- Cancer Bank v1.1 - Physical Function
|
3 months
|
App-based User Data
Time Frame: 3 months
|
Users' self-reported stress, biometrics and engagement
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Linda Carlson, PhD, University Of Calgary
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HREBA.CC-18-0029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
Clinical Trials on Mindfulness
-
University of Illinois at Urbana-ChampaignNorthwestern University Feinberg School of Medicine; Southern Illinois University and other collaboratorsNot yet recruitingPain, Postoperative | Depression, Unipolar
-
University of HoustonCompletedDepression | Stress | Anxiety | Well-beingUnited States
-
University of UlsterRecruitingCervical Cancer | Gynecologic Cancer | Vulvar Cancer | Vaginal Cancer | Uterus Cancer | Ovary CancerUnited Kingdom
-
University of HawaiiVA Palo Alto Health Care SystemCompletedCancer, Other Than Non-melanoma Skin CancerUnited States
-
Monash University MalaysiaCompleted
-
Oregon Health and Science UniversityPortland VA Medical CenterCompleted
-
Lund UniversityCompleted
-
Jordan University of Science and TechnologyCompleted