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Behavioral Intervention
Mindfulness App for Cancer Survivors (SEAMLESS Trial)
N/A
Recruiting
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults ≥ 18 years
Diagnosed with any type of cancer (stages I-IV)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
SEAMLESS Trial Summary
This trial will evaluate a mobile app-based intervention for cancer survivors post-treatment to see if it is an effective way to deliver psychosocial cancer-care.
Who is the study for?
This trial is for English or French-speaking cancer survivors over 18 who've finished primary treatment at least 2 weeks ago. They must be willing to practice mindfulness daily using an app and have a smartphone with internet. It's not for those with cognitive impairments, weekly mindfulness experience, or current major depression.Check my eligibility
What is being tested?
The study tests the 'MBCS Journey' app, a mobile version of Mindfulness-based Cancer Recovery program. Participants are randomly placed in two groups: one starts immediately, while the other waits three months before beginning the four-week mind-body intervention.See study design
What are the potential side effects?
As this is a non-medical intervention focusing on mindfulness through an app, significant side effects are not expected. However, participants may experience emotional discomfort when engaging in self-reflection practices.
SEAMLESS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with cancer at any stage.
SEAMLESS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Calgary Symptoms of Stress Inventory (C-SOSI)
Secondary outcome measures
App-based User Data - Mood
App-based User Data - Objective Stress
App-based User Data - Perceived Stress
+5 moreSEAMLESS Trial Design
2Treatment groups
Experimental Treatment
Group I: Immediate MindfulnessExperimental Treatment1 Intervention
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.
Group II: Control MindfulnessExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness
2014
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
122 Previous Clinical Trials
66,807 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,336 Previous Clinical Trials
25,750,763 Total Patients Enrolled
2 Trials studying Mental Health
3,137 Patients Enrolled for Mental Health
University of CalgaryLead Sponsor
783 Previous Clinical Trials
845,584 Total Patients Enrolled
2 Trials studying Mental Health
8,792 Patients Enrolled for Mental Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I finished my main cancer treatment at least 2 weeks ago.I have been diagnosed with cancer at any stage.I can complete health surveys in English or French before the study starts.I have untreated depression or other mental health issues that could affect my participation.I am willing to practice mindfulness daily for 20-30 minutes over 4 weeks.I am willing to complete the MBCS Journey and its follow-up questionnaires.
Research Study Groups:
This trial has the following groups:- Group 1: Control Mindfulness
- Group 2: Immediate Mindfulness
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there capacity available for new enrollees in this clinical research?
"Clinicaltrials.gov showcases that recruitment for this trial has been concluded, with its posting on July 1st 2022 and last edit occuring 19th of the same month. Although enrollment is no longer possible, there are still 503 other medical studies enrolling people at present."
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