Trial Title:
Food for Thought - a Nutrition Intervention for Women Undergoing Active Treatment for Triple Negative Breast Cancer
NCT ID:
NCT06582615
Condition:
Anatomic Stage II Breast Cancer AJCC V8
Anatomic Stage III Breast Cancer AJCC V8
Triple-Negative Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Parallel design with optional cross-over of the control group to the treatment group
after 6-month follow-up.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo dried blood spot collection
Arm group label:
Arm I (MIND-TNBC counseling)
Arm group label:
Arm II (general health recommendations counseling)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Cognitive Assessment
Description:
Ancillary studies
Arm group label:
Arm I (MIND-TNBC counseling)
Arm group label:
Arm II (general health recommendations counseling)
Intervention type:
Other
Intervention name:
Dietary Intervention
Description:
Receive MIND counseling sessions
Arm group label:
Arm I (MIND-TNBC counseling)
Other name:
Dietary Modification
Other name:
intervention, dietary
Other name:
Nutrition Intervention
Other name:
Nutrition Interventions
Other name:
Nutritional Interventions
Intervention type:
Other
Intervention name:
Dietary Intervention
Description:
Follow a personalized diet
Arm group label:
Arm I (MIND-TNBC counseling)
Other name:
Dietary Modification
Other name:
intervention, dietary
Other name:
Nutrition Intervention
Other name:
Nutrition Interventions
Other name:
Nutritional Interventions
Intervention type:
Other
Intervention name:
Dietary Intervention
Description:
Receive general health recommendations counseling sessions
Arm group label:
Arm II (general health recommendations counseling)
Other name:
Dietary Modification
Other name:
intervention, dietary
Other name:
Nutrition Intervention
Other name:
Nutrition Interventions
Other name:
Nutritional Interventions
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Wear a Fitbit
Arm group label:
Arm I (MIND-TNBC counseling)
Arm group label:
Arm II (general health recommendations counseling)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (MIND-TNBC counseling)
Arm group label:
Arm II (general health recommendations counseling)
Summary:
The goal of this randomized clinical trial is to learn if a healthy eating pattern called
the MIND eating plan can reduce cancer-related cognitive impairment (commonly called
"chemobrain") and other symptoms commonly experienced by women with newly diagnosed stage
II-III triple negative breast cancer as they go through chemotherapy. The symptoms that
will be measured include changes in memory and mental function, fatigue, sleep quality,
anxiety, and depression.
Researchers will compare measures from women in the 12-week MIND eating plan virtual
intervention to a general health coaching (GHC) virtual intervention to see if the MIND
eating plan helps reduce symptoms. Women will be contacted for follow-up measures 6
months after the 12-week interventions.
Women randomly assigned to the GHC at the beginning of the study will have the
opportunity to complete the MIND intervention after the 6-month follow-up. All study
sessions and measures are done remotely.
Participants will:
- Be randomized to MIND or GHC interventions
- Complete all study measures remotely (by online questionnaires, virtual visits and
mail )
- Attend 8 virtual sessions of about 15-60 minutes each over 12 weeks
- Be sent some of the key foods in the MIND eating plan during the MIND intervention
- Be contacted for follow-up measures 6 months after interventions
Detailed description:
PRIMARY OBJECTIVES:
I. Evaluate the efficacy of a remotely delivered, highly accessible, 3-month MIND diet
intervention (MIND-Breast Cancer [BC]) versus (vs.) general health curriculum (GHC)
control to reduce CRCI and associated neuropsychological symptoms in 60 racially and
ethnically diverse women with clinical stage II-III TNBC.
II. Evaluate the sustainability of dietary changes and outcome measures 6-months
post-intervention.
EXPLORATORY OBJECTIVE:
I. Explore underlying mechanisms of the MIND-BC diet on CRCI and effects of early versus
later participation in the dietary intervention.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive MIND counseling sessions over 30-60 minutes weekly for 4 weeks
then over 15 minutes biweekly for 4 sessions over 8 weeks and follow a personalized diet
for 12 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on
study and during follow up.
ARM II: Patients receive general health recommendations counseling sessions over 30-60
minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks.
Patients also wear a Fitbit and undergo dried blood spot collection on study and during
follow up. After 6 month follow-up, patients may receive the MIND counseling sessions as
in Arm I.
After completion of study intervention, patients are followed up at 6 months.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 40-65 years
- Female with newly diagnosed stage II-III triple negative breast cancer
- Within 3 weeks prior to starting neoadjuvant chemotherapy OR up to 6 months after
starting neoadjuvant chemotherapy
- Ability to access and use internet resources, including video calls using Zoom
platform
- English speaking
Exclusion Criteria:
- History of dementia, stroke, traumatic brain injury, brain metastasis or other
conditions that could lead to cognitive impairment
- Current healthy eating pattern reflected by high MIND diet score (e.g. > 8)
- Unwilling/unable to eat > 2 types of MIND food (e.g. avoids > 2 categories or
food groups such as leafy greens, olive oil and non-fried fish)
- Currently pregnant
- Unable to give informed consent
Gender:
Female
Minimum age:
40 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Yale University
Address:
City:
New Haven
Zip:
06519
Country:
United States
Status:
Recruiting
Contact:
Last name:
Maryam Lustberg, MD, MPH
Phone:
203-200-2328
Email:
maryam.lustberg@yale.edu
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tonya Orchard, PhD
Phone:
614-292-7241
Email:
Orchard.6@osu.edu
Contact backup:
Last name:
Tonya Orchard
Start date:
October 28, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
American Institute for Cancer Research
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06582615
http://cancer.osu.edu
