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Trial Title:
Mindfulness Intervention for Improving Nutrition in the Digital Kitchen Among Stage I-III Breast Cancer Survivors, MIND Trial
NCT ID:
NCT06643455
Condition:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Behavioral Dietary Intervention
Description:
Participate in the MIND program
Arm group label:
Arm A (MIND program)
Intervention type:
Other
Intervention name:
Best Practice
Description:
Participate in SOC
Arm group label:
Arm B (waitlist control)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Other
Intervention name:
Electronic Medical Record
Description:
Ancillary studies
Arm group label:
Arm A (MIND program)
Arm group label:
Arm B (waitlist control)
Other name:
Computer Based Patient Record
Other name:
EMR
Other name:
EMR (electronic medical record)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm A (MIND program)
Arm group label:
Arm B (waitlist control)
Summary:
This trial tests how well a remotely-delivered nutrition and culinary intervention works
to improve diet quality among stage I-III breast cancer survivors. Despite the strong
evidence demonstrating the benefits of healthy nutrition on improving cancer outcomes,
most breast cancer survivors, do not meet the nutrition recommendations The use of
technology in behavioral interventions is proving to be a cost-effective mode of
delivering lifestyle education to promote behavior change. The Mindfulness Intervention
for Nutrition in the Digital Kitchen (MIND) program is delivered through a learning
management system on the Cook for Your Life platform (cookforyourlife.org). The Cook for
Your Life platform is a cancer patient-facing interactive program offering free nutrition
and healthy cooking information, recipes, and cooking videos that disseminate
evidence-based information on nutrition and cancer survivorship. The MIND program may
help improve diet quality and increase fruit and vegetable intake among stage I-III
breast cancer survivors.
Detailed description:
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A (INTERVENTION): Patients participate in the MIND program consisting of self-paced
online education on nutrition, chef demo skills-building cooking, and mindfulness
practice over 4 hours weekly for 6 weeks.
ARM B (WAITLIST CONTROL): Patients participate in standard of care (SOC) for 6 weeks.
Patients may optionally receive access to the MIND program following the initial 6-week
study period.
After completion of study intervention, patients are followed up at 12 weeks.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18 years of age or older.
- Previous diagnosis of stage I-III breast cancer in the past 5 years at the time of
enrollment.
- No evidence of current, recurrent or metastatic disease.
- At least 60 days post final chemotherapy, biologic therapy, or radiation therapy
and/or surgery. The following which are allowed: HER2-targeted therapies, CDK4/6
inhibitor (abemaciclib or ribociclib), endocrine therapy (aromatase inhibitors,
ovarian suppression therapy, and tamoxifen), PARP inhibitors (olaparib), and
zolendronic acid.
- Rationale: these treatments are allowed as the majority of early stage breast
cancer survivors receive at least one of these therapies for one or more years
following diagnosis; our goal is to test this intervention in a population
where the findings will be generalizable to a large population of breast cancer
survivors).
- Access to phone for study contacts.
- Access to smartphone, tablet, or computer and internet to attend online program.
- Willing and able to complete all study activities after randomization, including
completing surveys online, at-home, and over the telephone assessments.
- Able to understand and willing to sign written informed electronic (e) consent in
English (note: though Dr. Greenlee's research group has conducted many trials in
Spanish-speaking populations, we did not have the funding to develop and test the
intervention in the Spanish language; should the MIND program show evidence of
preliminary efficacy we will seek funding to develop and test the intervention in
Spanish.).
- Eastern Cooperative Oncology Group (ECOG) status of 0-2.
- Participants must not be actively smoking within the past 30 days. Active smoking is
defined as any smoking, even a puff. Participants who smoke are much less likely to
engage in healthy lifestyle behaviors, and it is probably more important for
participants to stop smoking than it is to change their dietary patterns. If
identified as actively smoking, the individual will be referred to the local
resources, Washington State Quitline (1-800-QUIT-NOW), ICanQuit.org, Quit2Heal.org,
the national resource, Centers for Disease Control and Prevention (CDC) "Quit Now"
phone line which supports smoking cessation, or the NIH quit support website
"SmokeFree.gov.
- Participants must consume < 5 servings of fruits and vegetables per day as assessed
by a brief questionnaire.
- Physician approval to participate in the MIND program dietary intervention.
- At the time of enrollment, women must not be pregnant or lactating or planning to
become pregnant in the next 6 months.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Contact:
Last name:
Jenny Whitten-Brannon
Phone:
206-667-5625
Email:
jwhitten@fredhutch.org
Investigator:
Last name:
Heather Greenlee
Email:
Principal Investigator
Start date:
January 1, 2025
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Fred Hutchinson Cancer Center
Agency class:
Other
Collaborator:
Agency:
Apex Foundation
Agency class:
Other
Source:
Fred Hutchinson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06643455
