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2023-09-12
2026-02-13
2026-06
40
NCT06050395
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
INTERVENTIONAL
The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response
The purpose of the study is to evaluate the feasibility and acceptability of a remote nutrition coaching and monitoring intervention during the 12-weeks of active chemotherapy for borderline resectable and locally advanced pancreatic cancer participants.
N/A
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-09-11 | N/A | 2025-09-12 |
2023-09-15 | N/A | 2025-09-15 |
2023-09-22 | N/A | 2025-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response Participants randomized to the MONITOR arm will be provided dietary coaching biweekly to discuss nutrition concerns, anti-inflammatory diet compliance, and set SMART goals based on their most recent Vioscreen food frequency questionnaires. | BEHAVIORAL: Quality fo Life Questionnaire (FHSI)
BEHAVIORAL: Vioscreen Food Frequency Questionnaire (FFQ)
BEHAVIORAL: NutritionCoaching
BEHAVIORAL: Follow-Up Survey
BEHAVIORAL: Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire
BEHAVIORAL: Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire
|
| ACTIVE_COMPARATOR: Standard Usual Care Standard Usual Care participants will receive usual nutrition care received in the Moffitt Cancer Center pancreatic clinic, in addition to handouts on diet. | BEHAVIORAL: Quality fo Life Questionnaire (FHSI)
BEHAVIORAL: Educational Handouts
BEHAVIORAL: Follow-Up Survey
BEHAVIORAL: Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire
BEHAVIORAL: Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Recruitment Rate -Feasibility | The study will be deemed feasible if >/= 60% of eligible participants are enrolled | Up to 8 months |
| Retention Rate - Feasibility | The study will be deemed feasible if >/=70% of participants complete the post-intervention questionnaire | at 12 weeks |
| Adherence - Feasibility | The study will be deemed feasible if average attendance is >/=4 weeks of sessions (out of 6) for MONITOR arm | at 12 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Participant Satisfaction with Overall Program- Acceptability | The study will be deemed acceptable based on the satisfaction score on follow-up survey. The follow-up survey uses open-ended and likert-style questions regarding 1) relevance and applicability of the MONITOR intervention content and objective/subjective data collection methods; 2) intervention length and timing; and 3) barriers/facilitators to participation and retention. On a 5-point Lkert-type scale, a(1) =strongly agree and e(5)=strongly disagree. Participant Satisfaction with Overall Program is determined by a score >/=3 on a 5-point scale. | at 12 weeks |
| Participant intent to continue using skills- Acceptability | The study will be deemed acceptable based on the satisfaction score on follow-up survey. The follow-up survey uses open-ended and likert-style questions regarding 1) relevance and applicability of the MONITOR intervention content and objective/subjective data collection methods; 2) intervention length and timing; and 3) barriers/facilitators to participation and retention. On a 5-point Lkert-type scale, a(1) =strongly agree and e(5)=strongly disagree. Participant intent to continue using skills- is determined by a score >/=3 on a 5-point scale. | at 12 weeks |
| Participant perception of utility of knowledge gained - Acceptability | The study will be deemed acceptable based on the satisfaction score on follow-up survey. The follow-up survey uses open-ended and likert-style questions regarding 1) relevance and applicability of the MONITOR intervention content and objective/subjective data collection methods; 2) intervention length and timing; and 3) barriers/facilitators to participation and retention. On a 5-point Lkert-type scale, a(1) =strongly agree and e(5)=strongly disagree. Participant perception of utility of knowledge gained is determined by a score >/=3 on a 5-point scale. | at 12 weeks |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
