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: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online mindfulness program designed to manage chemotherapy side effects, such as fatigue, nausea, and sleep issues, which significantly impact daily life. The program, Mindfulness-Based Cancer Recovery (MBCR), is delivered in weekly online sessions. Participants are divided into two groups: one begins the program during chemotherapy, and the other starts afterward. The trial seeks breast or colorectal cancer patients with internet access who can attend online classes. The goal is to determine if this program can improve energy levels and overall quality of life during chemotherapy. As an unphased trial, this study provides a unique opportunity to explore innovative ways to enhance well-being during cancer treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this online mindfulness program is safe for chemotherapy patients?

Studies have shown that Mindfulness-Based Cancer Recovery (MBCR) programs are generally well-tolerated by cancer patients. Research indicates that these programs help reduce anxiety and depression, common in patients undergoing chemotherapy. One study specifically found that MBCR improved quality of life during chemotherapy by addressing issues like tiredness and trouble sleeping.

Reports from previous patients have not highlighted any major negative effects linked to MBCR. This suggests that the online version of MBCR can be a safe option for managing chemotherapy side effects. Since this is a "Not Applicable" trial phase, MBCR's safety relies on its use in other situations, where it has been shown to be safe and helpful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Online Mindfulness Based Cancer Recovery (MBCR) program because it offers a novel approach to managing chemotherapy side effects compared to standard treatments like medication for nausea and pain relief. Unlike traditional methods, this treatment is delivered through 12 weekly online sessions, making it easily accessible for patients from the comfort of their homes. The focus on mindfulness provides a unique mechanism by helping patients manage stress and improve overall well-being, which can potentially enhance their quality of life during chemotherapy. This innovative approach is promising because it empowers patients with tools to cope mentally and emotionally, complementing their physical treatment.

What evidence suggests that online MBCR is effective for chemotherapy side effects?

Research has shown that Mindfulness-Based Cancer Recovery (MBCR) helps cancer patients manage chemotherapy side effects. Studies have found that MBCR reduces fatigue, a common and challenging symptom for those undergoing chemotherapy. Participants in similar programs have reported improvements in mood, stress, and overall quality of life. Evidence also suggests that online mindfulness programs effectively lower anxiety and depression in cancer patients. This trial will compare an immediate MBCR intervention with a waitlist control group. These findings support the idea that online MBCR can effectively manage symptoms related to chemotherapy. ^{1 2 5 6 7}

Who Is on the Research Team?

Linda E Carlson, PhD

Principal Investigator

University of Calgary

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.

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.

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?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31056784/

Rationale and protocol for assessing the effects of ONlinE ... This study aims to determine the efficacy of an online group MBCR programme delivered during CT in 12 real-time interactive weekly sessions for managing ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ecc.13074

The ONE‐MIND Study: Rationale and protocol for ... If online MBCR delivered during CT significantly reduces fatigue in cancer patients' post-CT and also impacts secondary symptoms, this would ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11495976/

Effects of internet-delivered mindfulness-based cancer ... To analyze the impact of a 4-week Internet-delivered mindfulness-based cancer recovery program on anxiety, depression, and mindfulness among Chinese patients ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0272735824001260

Positive health outcomes of mindfulness-based ... Taken together, significant effects of MBIs were found for several positive outcomes in cancer patients and survivors, with the strongest evidence found for ...

5. jmir.org jmir.org/2022/11/e40059/

Effect of a 4-Week Internet-Delivered Mindfulness-Based ... This study aimed to investigate the effectiveness of a 4-week internet-delivered mindfulness-based cancer recovery (iMBCR) program in reducing symptom burden

6. journals.lww.com journals.lww.com/md-journal/fulltext/2024/06070/effects_of_mindfulness_based_cancer_recovery.74.aspx

Effects of Mindfulness-Based Cancer Recovery training on... Studies have reported positive rates of anxiety symptoms and depressive symptoms in breast neoplasm patients of 20.2% and 45.2%, 5 while the ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03484000

The ONE-MIND Study: Evaluating the Efficacy of Online ... Mindfulness-Based Cancer Recovery (MBCR) is an evidence-based group training program which has shown to help treat negative physical and psychosocial symptoms ...