178 Participants Needed

Online Mindfulness for Chemotherapy Side Effects

LE
Overseen ByLinda E Carlson, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Calgary
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Background: Chemotherapy treatment (CT) can have burdensome side effects such as fatigue, nausea-vomiting, and sleep problems that can significantly affect patients' quality of life. Fatigue is the most common, lasting and bothersome of these, which prevents people from working and carrying out daily activities. Mindfulness-Based Cancer Recovery (MBCR) is an evidence-based group training program which has shown to help treat negative physical and psychosocial symptoms in cancer patients. The investigators propose to evaluate a pilot-tested online-MBCR program for patients undergoing CT who may be low on energy, time or have compromised immunity.Objectives: To evaluate the impact of participation in online MBCR during CT on fatigue (primary outcome), sleep, pain, nausea/vomiting, mood disturbance, stress symptoms and quality of life (secondary outcomes) as well as cognitive function and return to work (exploratory outcomes) over the course of treatment.Methods: The study design is a randomized wait-list controlled trial, conducted during CT for patients with breast or colorectal cancer. Participants will take the 12-week online MBCR program at home within 2 weeks of randomization (immediate group) or after CT completion (waitlist group). Outcomes will be assessed online at, 1) Baseline, 2) Post-MBCR, 3) Post-CT (primary outcome) and 4) 12 months post-baseline.Anticipated Findings: MBCR is a promising adjuvant program that could help patients prevent, delay or diminish aversive symptoms and side-effects associated with CT, particularly fatigue. If helpful, online-MBCR could be made easily available at cancer centers worldwide and significantly lessen the burden of cancer treatments.

Who Is on the Research Team?

LE

Linda E Carlson, PhD

Principal Investigator

University of Calgary

BD

Barry D Bultz, PhD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am over 18 years old.
I am scheduled for specific chemotherapy before or after surgery.
You must have access to fast internet every week.
See 5 more

Exclusion Criteria

You have already participated in a mindfulness-based stress reduction program in the past five years.
I am currently diagnosed with a major psychiatric disorder.
My cancer has spread to other parts of my body.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo chemotherapy treatment while participating in a 12-week online Mindfulness-Based Cancer Recovery (MBCR) program

12 weeks
12 weekly online sessions

Follow-up

Participants are monitored for fatigue and other outcomes post-treatment

6 months

Waitlist Control

Participants in the waitlist control group receive the MBCR program after completing chemotherapy

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Online Mindfulness Based Cancer Recovery (MBCR)
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Waitlist control groupExperimental Treatment1 Intervention
Group II: Immediate MBCR groupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+
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