CancerBLOOMINCT06628141
Enhancing Quality of Life in Cancer Patients Through Tailored Nutrition Support: a Comprehensive Approach
A study testing Nutritional support tool in people with Cancer, run by UOMi Cancer Center at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Nutritional support tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 14 Nov 2023to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
UOMI Cancer Center Clínica Mi Tres Torres
Barcelona, Barcelona, 08017
Marco Angeloni, +34633344566, marco@timblo.es
About this study
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.
- Conditions
- Cancer
- Being tested
- Nutritional support tool
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional support toolOther
Nutritional support tool
| Study group | Role | What they receive |
|---|---|---|
| Nutritional support tool | Experimental | Not described Receives: Other: Nutritional support tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start14 Nov 2023
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UOMi Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dexeus Clinic Woman
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628141
- Sponsor's protocol ID
- UOMi Cancer Center
- Acronym
- BLOOMI
- Status last verified
- Oct 2024
- First submitted
- 22 Nov 2023
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Quality of Life in Cancer Patients Through Tailored Nutrition Support: a Comprehensive Approach
- ClinicalTrials.gov ID
- NCT06628141
- Acronym / sponsor ID
- BLOOMI / UOMi Cancer Center
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- UOMi Cancer CenterUniversity, hospital or other
- Collaborators
- Dexeus Clinic Woman
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional support tool | Experimental | Other: Nutritional support tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional support toolNutritional support tool | Other | Nutritional support tool |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional support tool in people with Cancer, run by UOMi Cancer Center at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome Measure: Dietary Adherence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.