NCT06628141

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2023

Completed
11 months until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

12 months

First QC Date

November 22, 2023

Last Update Submit

October 2, 2024

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Outcome Measure: Dietary Adherence

    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

Study Arms (1)

Nutritional support tool

EXPERIMENTAL
Other: Nutritional support tool

Interventions

Nutritional support toolOTHER

Nutritional support tool

Nutritional support tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with an eating disorder of psychiatric or psychological origin, diagnosed before cancer treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UOMI Cancer Center Clínica Mi Tres Torres

Barcelona, Barcelona, 08017, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2023

First Posted

October 4, 2024

Study Start

November 14, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

October 4, 2024

Record last verified: 2024-10

Locations

ES(1)