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NCT04293874 · ClinicalTrials.gov registry record · NA
Adaptive Symptom Care Using Fish-Based Nutritional Directives Post Breast Cancer
A NA study, sponsored by University of Connecticut.
- Completed
- Registry status
- NA
- Development phase
- 98
- Enrollment target
NCT04293874: Completed NA study, sponsored by University of Connecticut.
NCT04293874 is a NA study that has completed, run by University of Connecticut. The registered enrollment target is 98 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04293874, a NA study, has completed, sponsored by University of Connecticut.
- COMPLETED
- Registry status
- NA
- Development phase
- 98 participants
- Enrollment target
Study Summary
Inflammation has been consistently associated with psychoneurological symptoms (PNS) among breast cancer survivors (BCS). Evidence supporting interventional strategies promoting symptom-self management in reducing inflammation-induced PNS in BCS is limited. Current guidelines for BCS encourage the consumption of foods rich in omega-3 fatty acids. The omega-3 fatty acid docosahexaenoic acid (DHA), abundantly available in fish, has a role in inflammatory downregulation. Low dietary DHA has been associated with inflammation and fatigue in BCS. Dietary planning targeting increased fish consumption thereby reducing red and processed meats are components of the major nutritional recommendations for BCS. A critical gap exists in knowledge regarding interventions promoting adherence to dietary guidelines in BCS supporting PNS self-management. This investigation uses personalized meal planning among BCSs (n=150) who are 1-2 years post-treatment for early-stage breast cancer and experiencing PNS (pain, fatigue, depression, sleep disturbance, stress) to evaluate the feasibility of a personalized meal planning approach in supporting adherence to current dietary guidelines for BCS. As a first step in this program of research, we will evaluate the feasibility of an personalized meal planning approach in promoting adherence to dietary guidelines for BCS through evaluating the feasibility of a personalized meal planning approach in a cohort of BCSs with respect to recruitment, group allocation, salivary inflammatory quantification and receptivity to and adherence with dietary interventions. This investigation will also contribute to a preliminarily evaluation of the efficacy of high or low fish diet in reducing inflammation (IL-1β, IL-6, TNF-a) and PNS symptoms. Nationally, there is a priority for the development of personalized health strategies supporting self-management of adverse symptoms. This investigation focused on PNS in BCS is an initial step in generating new knowledge i
Primary Outcome
Epidemiological Studies Depression Scale is 20-item self-report instrument. Each item is scored 0-4 at a 4-point scale, yielding a total between 0 and 80. A higher score indicates a worse depressive symptom.
Interventions
- BEHAVIORAL Personalized Meal Plan
- BEHAVIORAL Dietary Omega-3LC intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2018-04-11 |
| Est. Completion | 2020-11-01 |
| Phase | NA |
What the finished NCT04293874 record still lists
NCT04293874 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Personalized Meal Plan is the first listed.
NCT04293874 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04293874 about?
NCT04293874 is a clinical study titled "Adaptive Symptom Care Using Fish-Based Nutritional Directives Post Breast Cancer". Inflammation has been consistently associated with psychoneurological symptoms (PNS) among breast cancer survivors (BCS). Evidence supporting interventional strategies promoting symptom-self management in reducing inflammation-induced PNS in BCS is limited. Current guidelines for BCS encourage the c...
What is the current status of trial NCT04293874?
This trial is currently completed. It is a NA study. The enrollment target is 98 participants. The study started on 2018-04-11. Estimated completion is 2020-11-01.
What interventions are being tested in trial NCT04293874?
The interventions under investigation include: Personalized Meal Plan (BEHAVIORAL), Dietary Omega-3LC intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04293874?
This trial is sponsored by University of Connecticut, which has 107 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04293874's enrollment target sits among peer trials
98 922nd of 2000 higher than 1,078 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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