- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06628141
Enhancing Quality of Life in Cancer Patients Through Tailored Nutrition Support: a Comprehensive Approach (BLOOMI)
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08017
- Recruiting
- UOMI Cancer Center Clínica Mi Tres Torres
-
Contact:
- Marco Angeloni
- Phone Number: +34633344566
- Email: marco@timblo.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
|
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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