Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582615
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Food for Thought - a Nutrition Intervention for Women Undergoing Active Treatment for Triple Negative Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Food for Thought - Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Triple Negative Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIND-TNBC
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None