The ONE-MIND Study: Evaluating the Efficacy of Online Mindfulness-Based Cancer Recovery During Chemotherapy Treatment

NCT ID: NCT03484000

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2025-01-01

Brief Summary

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.

Conditions

Breast Cancer; Colorectal Cancer; Chemotherapy Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Immediate MBCR group

The Online Mindfulness Based Cancer Recovery (MBCR) program intervention is delivered in 12 weekly real-time interactive 55-minute sessions offered over consecutive weeks.

Group Type: EXPERIMENTAL

Online Mindfulness Based Cancer Recovery (MBCR)

Intervention Type: BEHAVIORAL

MBCR is a group behavioral treatment that trains participants in mindfulness techniques through meditation and gentle mindful movement

Waitlist control group

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 Type: OTHER

Online Mindfulness Based Cancer Recovery (MBCR)

Intervention Type: BEHAVIORAL

MBCR is a group behavioral treatment that trains participants in mindfulness techniques through meditation and gentle mindful movement

Interventions

Online Mindfulness Based Cancer Recovery (MBCR)

MBCR is a group behavioral treatment that trains participants in mindfulness techniques through meditation and gentle mindful movement

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Men and women over the age of 18

2. Diagnosed with either a) stage I-III HER 2 normal breast carcinoma or b) Stage II-III colorectal carcinoma

3. Scheduled to undergo either neoadjuvant or adjuvant: a) FEC- D or AC-T chemotherapy or b) FOLFOX or CAPEOX chemotherapy

4. Weekly access to high-speed internet

5. Access to a computer/tablet/smart phone

6. Able to attend MBCR classes at scheduled times

7. Sufficient ability to speak and read English

8. Willingness to be randomized into immediate or waitlist groups and complete all assessments

Exclusion Criteria

1. Metastatic patients

2. Suffering from current Major Depressive Disorder, Bipolar Disorder or other psychiatric disorder (self-report)

3. Currently engaging in meditation one or more times per week within the previous year.

4. Participation in an MBCR or MBSR program in the last five years.

5. Cognitive impairment (>6 on the Brief Screen for Cognitive Impairment)

6. Physical functional impairment that would interfere with the ability to participate in the intervention (on the PAR-Q questionnaire)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Linda E. Carlson

Enbridge Research Chair in Psychosocial Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linda E Carlson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Barry D Bultz, PhD

Role: STUDY_CHAIR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Linda E Carlson, PhD

Role: CONTACT

lcarlso@ucalgary.ca

14033553207

Facility Contacts

Linda E Carlson, PhD

Role: primary

lcarlso@ucalgary.ca

14033553207

References

Subnis UB, Farb NA, Piedalue KL, Speca M, Lupichuk S, Tang PA, Faris P, Thoburn M, Saab BJ, Carlson LE. A Smartphone App-Based Mindfulness Intervention for Cancer Survivors: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 May 11;9(5):e15178. doi: 10.2196/15178.

Reference Type: DERIVED

PMID: 32390591 (View on PubMed)

Other Identifiers

HREBA.CC-18-0028

Identifier Type: -

Identifier Source: org_study_id