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Behavioral Intervention
Mindfulness App for Cancer Survivors (SEAMLESS Trial)
N/A
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Calgary Symptoms of Stress Inventory (C-SOSI)
Secondary study objectives
App-based User Data - Mood
App-based User Data - Objective Stress
App-based User Data - Perceived Stress
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 2
~3200
Find a Location
Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,385 Previous Clinical Trials
26,515,590 Total Patients Enrolled
2 Trials studying Mental Health
3,137 Patients Enrolled for Mental Health
Canadian Cancer Trials GroupLead Sponsor
131 Previous Clinical Trials
69,202 Total Patients Enrolled
University of CalgaryLead Sponsor
808 Previous Clinical Trials
884,044 Total Patients Enrolled
2 Trials studying Mental Health
8,792 Patients Enrolled for Mental Health
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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: Immediate Mindfulness
- Group 2: Control 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.
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