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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03484000
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : May 11, 2023
Sponsor:
Information provided by (Responsible Party):
Linda E. Carlson, University of Calgary

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Chemotherapy Effect Behavioral: Online Mindfulness Based Cancer Recovery (MBCR) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Fatigue [ Time Frame: 6 months ]
    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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484000


Contacts
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Contact: Linda E Carlson, PhD 14033553207 lcarlso@ucalgary.ca

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N3C1
Contact: Linda E Carlson, PhD    14033553207    lcarlso@ucalgary.ca   
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Linda E Carlson, PhD University of Calgary
Study Chair: Barry D Bultz, PhD University of Calgary
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Linda E. Carlson, Enbridge Research Chair in Psychosocial Oncology, University of Calgary
ClinicalTrials.gov Identifier: NCT03484000    
Other Study ID Numbers: HREBA.CC-18-0028
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: May 11, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases