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

Breast Cancer Clinical Trial

Official title:

The ONE-MIND Study: Evaluating the Efficacy of Online Mindfulness-Based Cancer Recovery (MBCR) During Chemotherapy Treatment (CT) to Impact Fatigue, Side Effects and Quality of Life (QL) in a Randomized Waitlist Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03484000
• Other study ID #: HREBA.CC-18-0028
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2023
• Source: University of Calgary
• Contact: Linda E Carlson, PhD
• Phone: 14033553207
• Email: lcarlso[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: January 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Chemotherapy Effect
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Online Mindfulness Based Cancer Recovery (MBCR)
MBCR is a group behavioral treatment that trains participants in mindfulness techniques through meditation and gentle mindful movement

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	Fatigue will be measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F 68) is the most commonly-used cancer-related fatigue scale. Using a 5-point Likert scale (from "not at all" to "very much"), the 13-items reflect participants' specific fatigue concerns in the past 7 days. The total score has well-established norms both in the literature and from our prior work and shows responsiveness to intervention	6 months