Enhancing Quality of Life in Cancer Patients Through Tailored Nutrition Support: a Comprehensive Approach (BLOOMI)

October 2, 2024 updated by: UOMi Cancer Center
The study aims to investigate the impact of a dedicated nutritional assistance tool on patients with cancer and to measure its effects on several proposed indicators.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08017
        • Recruiting
        • UOMI Cancer Center Clínica Mi Tres Torres
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients affected by cancer, who decided to participate to the study, signed the informed consent and whose life expectancy is higher than 1 (one) year.

Exclusion Criteria:

  • Patients with an eating disorder of psychiatric or psychological origin, diagnosed before cancer treatment.
  • Any other exclusion criteria as determined by the oncologist based on the patient's ability to successfully complete the program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutritional support tool
Other: Nutritional support tool
Nutritional support tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome Measure: Dietary Adherence
Time Frame: 1 year

Dietary adherence will be measured by comparing the planned recipes provided to participants with the meals they report consuming each week. Participants receive 21 recipe suggestions (7 breakfasts, 7 lunches, 7 dinners) via a mobile app. The following tools and methods will assess adherence:

Mobile Application Tracking: The app tracks participants' views of recipes and ingredient purchases via the integrated shopping list.

Weekly Questionnaire: A self-reported questionnaire asks if participants:

Followed the recipes using ingredients purchased via the app. Prepared recipes with their own ingredients. Ate meals not included in the plan. Adherence Calculation: Adherence is calculated as the ratio of recipes followed (via app or self-preparation) to the total number of recommended recipes (21 per week), expressed as a percentage.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UOMi Cancer Center

Collaborators

Dexeus Clinic Woman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

October 2, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

October 4, 2024

Last Update Submitted That Met QC Criteria

October 2, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • UOMi Cancer Center

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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