Online Mindfulness for Chemotherapy Side Effects

Overseen By Linda E Carlson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Metastatic cancer, Major depression, Bipolar, Meditation, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

178 Participants Needed

Trial Summary

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.

Research Team

Linda E Carlson, PhD

Principal Investigator

University of Calgary

Barry D Bultz, PhD

Principal Investigator

University of Calgary

Eligibility Criteria

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.

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.

Treatment Details

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.

Participant Groups

Group I: Waitlist control group Experimental Treatment 1 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 group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+