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Online Mindfulness for Chemotherapy Side Effects
N/A
Recruiting
Led By Linda E Carlson, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled to undergo either neoadjuvant or adjuvant: a) FEC- D or AC-T chemotherapy or b) FOLFOX or CAPEOX chemotherapy
Able to attend MBCR classes at scheduled times
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will test whether an online mindfulness-based cancer recovery program can help reduce chemotherapy side effects like fatigue, sleep problems, and mood disturbance.
Who is the study for?
This trial is for adults over 18 with stage I-III breast cancer or stage II-III colorectal cancer, about to start specific chemotherapy regimens. Participants need internet access and must be able to use a computer or smart device to attend online mindfulness sessions in English.Check my eligibility
What is being tested?
The study tests if an online Mindfulness-Based Cancer Recovery program can reduce fatigue and other side effects of chemotherapy like nausea, sleep issues, pain, mood disturbances, stress symptoms, and improve quality of life and cognitive function.See study design
What are the potential side effects?
Since the intervention involves mindfulness training rather than medication, no traditional medical side effects are expected. However, participants may experience emotional discomfort as they confront personal challenges during the practice.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for specific chemotherapy before or after surgery.
Select...
I can attend all scheduled MBCR classes.
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I have been diagnosed with early to mid-stage breast or colorectal cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fatigue
Trial Design
2Treatment groups
Experimental Treatment
Group I: Waitlist control groupExperimental Treatment1 Intervention
Treatment as usual, followed by a delayed (wait-list) intervention of the same Online Mindfulness Based Cancer Recovery (MBCR) program after the post-CT assessment.
Group II: Immediate MBCR groupExperimental Treatment1 Intervention
The Online Mindfulness Based Cancer Recovery (MBCR) program intervention is delivered in 12 weekly real-time interactive 55-minute sessions offered over consecutive weeks.
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Who is running the clinical trial?
University of CalgaryLead Sponsor
792 Previous Clinical Trials
868,976 Total Patients Enrolled
Linda E Carlson, PhDPrincipal InvestigatorUniversity of Calgary
2 Previous Clinical Trials
676 Total Patients Enrolled
Barry D Bultz, PhDStudy ChairUniversity of Calgary
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 years old.I am scheduled for specific chemotherapy before or after surgery.You have already participated in a mindfulness-based stress reduction program in the past five years.You must have access to fast internet every week.I am currently diagnosed with a major psychiatric disorder.My cancer has spread to other parts of my body.I can attend all scheduled MBCR classes.You have been practicing meditation at least once a week in the past year.I have been diagnosed with early to mid-stage breast or colorectal cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Waitlist control group
- Group 2: Immediate MBCR group
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.
How many participants are being enlisted in this clinical trial?
"Affirmative. The clinical trial platform, clinicaltrials.gov, has verified that this study is actively recruiting participants and was first posted on June 1st 2018. The most recent update occurred on May 19th 2022 and the team are looking for 178 individuals from a single site to be enrolled in the research."
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Is enrollment in this experiment currently available to participants?
"Clinicaltrials.gov indicates that this research is still actively seeking participants, first posted on June 1st 2018 and recently updated on May 19th 2022."
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