The ONE-MIND Study: Evaluating the Efficacy of Online Mindfulness-Based Cancer Recovery During Chemotherapy Treatment
1 other identifier
interventional
178
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Jun 2018
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2018
CompletedFirst Posted
Study publicly available on registry
March 30, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedMay 11, 2023
May 1, 2023
6.6 years
March 24, 2018
May 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Immediate MBCR group
EXPERIMENTALThe Online Mindfulness Based Cancer Recovery (MBCR) program intervention is delivered in 12 weekly real-time interactive 55-minute sessions offered over consecutive weeks.
Waitlist control group
OTHERTreatment as usual, followed by a delayed (wait-list) intervention of the same Online Mindfulness Based Cancer Recovery (MBCR) program after the post-CT assessment.
Interventions
MBCR is a group behavioral treatment that trains participants in mindfulness techniques through meditation and gentle mindful movement
Eligibility Criteria
You may qualify if:
- Men and women over the age of 18
- Diagnosed with either a) stage I-III HER 2 normal breast carcinoma or b) Stage II-III colorectal carcinoma
- Scheduled to undergo either neoadjuvant or adjuvant: a) FEC- D or AC-T chemotherapy or b) FOLFOX or CAPEOX chemotherapy
- Weekly access to high-speed internet
- Access to a computer/tablet/smart phone
- Able to attend MBCR classes at scheduled times
- Sufficient ability to speak and read English
- Willingness to be randomized into immediate or waitlist groups and complete all assessments
You may not qualify if:
- Metastatic patients
- Suffering from current Major Depressive Disorder, Bipolar Disorder or other psychiatric disorder (self-report)
- Currently engaging in meditation one or more times per week within the previous year.
- Participation in an MBCR or MBSR program in the last five years.
- Cognitive impairment (\>6 on the Brief Screen for Cognitive Impairment)
- Physical functional impairment that would interfere with the ability to participate in the intervention (on the PAR-Q questionnaire)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Calgary
Calgary, Alberta, T2N3C1, Canada
Related Publications (1)
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.
PMID: 32390591DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linda E Carlson, PhD
University of Calgary
- STUDY CHAIR
Barry D Bultz, PhD
University of Calgary
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Enbridge Research Chair in Psychosocial Oncology
Study Record Dates
First Submitted
March 24, 2018
First Posted
March 30, 2018
Study Start
June 1, 2018
Primary Completion
December 31, 2024
Study Completion
January 1, 2025
Last Updated
May 11, 2023
Record last verified: 2023-05