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Pancreatic CancerNCT06050395

The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response

A study testing Quality fo Life Questionnaire (FHSI), Vioscreen Food Frequency Questionnaire (FFQ) and Educational Handouts in people with Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Quality fo Life Questionnaire (FHSI), Vioscreen Food Frequency Questionnaire (FFQ) and Educational Handouts
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
12 Sep 2023to 13 Feb 2025
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

  • Men or women 18 years of age or more
  • Newly diagnosed, in place tumors of the pancreas
  • No documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis)
  • Able to speak and read English
  • Able to consume food orally
  • Chemotherapy naive
  • Scheduled to receive treatment with chemotherapy
  • Able to provide verbal informed consent

Who cannot join

  • Women who are pregnant
  • Pancreatic cancer not the primary diagnosis
  • Patients on enteral or parental nutrition
  • Patients with metastatic pancreatic cancer
  • Patients with evidence of impeding bowel obstruction
  • Patients presenting with ascites

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

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.

Being tested
Quality fo Life Questionnaire (FHSI), Vioscreen Food Frequency Questionnaire (FFQ), Educational Handouts, NutritionCoaching, Follow-Up Survey
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quality fo Life Questionnaire (FHSI)Behavioural

    Participants will take a survey at baseline and visit 2 (weeks 6-8), and visit 3 (week 10-14). The Functional Assessment of Cancer Therapy Hepatobiliary Cancer Symptom Index-8 (FHSI) questionnaire uses a 5-point Likert-type scale, 0=not at all and 4=Very much. A lower total score indicates better quality of life.

  • Vioscreen Food Frequency Questionnaire (FFQ)Behavioural

    Participants will receive a web-based link and information to complete VioScreen, a web-based food frequency questionnaire, which allows participants to choose the average frequency of consumption of food items over a given time frame (1 month, 3 month, 1 year, etc.) on a Likert scale with choices ranging by individual questions. Total energy and nutrient intake is estimated by summing intakes from each food based on the selected portion size, reported frequency of consumption, and nutrient content of each food item. Anti-inflammatory and pro-inflammatory dietary patterns are calculated using the energy-adjusted dietary inflammatory index (DII) score to represent the inflammatory potential of an individual's overall diet, using data from FFQ responses. Higher DII scores represent more pro-inflammatory diets while lower (i.e., more negative) DII scores represent more anti-inflammatory diet.

  • Educational HandoutsBehavioural

    Participants will receive educational handouts on diet.

  • NutritionCoachingBehavioural

    Participants will receive bi-weekly nutrition coaching on anti-inflammatory dietary patterns and foods.

  • Follow-Up SurveyBehavioural

    Participants will complete a custom exit/follow up survey regarding relevance, acceptability, intervention length and timing, an barriers/facilitators. This survey contains 38 questions scored from 1 -Strongly agree to 5-Strongly disagree. A lower score indicates patient satisfaction with the program and the skills and knowledge gained in the program.

  • Functional Assessment of Anorexia/Cachexia Treatment (FAACT) QuestionnaireBehavioural

    The FAACT questionnaire uses a 5 point Likert-type scale, 0=Not at all, 4=Very much. A higher score indicates better appetite and quality of life.

  • Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) QuestionnaireBehavioural

    Participants will complete the PROMIS-Cog form which measures self-reported cognitive deficits. The questionnaire uses a 5 point Likert-type scale, 1=Very often and 5=Never. A higher score indicates higher cognitive function.

Study groups in NCT06050395
Study groupRoleWhat they receive
MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment ResponseExperimentalParticipants 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.
Receives: 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
Standard Usual CareActive comparatorStandard Usual Care participants will receive usual nutrition care received in the Moffitt Cancer Center pancreatic clinic, in addition to handouts on diet.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate -Feasibility

    The study will be deemed feasible if >/= 60% of eligible participants are enrolled

    Measured: Up to 8 months

  2. Retention Rate - Feasibility

    The study will be deemed feasible if >/=70% of participants complete the post-intervention questionnaire

    Measured: at 12 weeks

  3. Adherence - Feasibility

    The study will be deemed feasible if average attendance is >/=4 weeks of sessions (out of 6) for MONITOR arm

    Measured: at 12 weeks

Secondary outcomes (3)

  1. 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.

    Measured: at 12 weeks

  2. 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.

    Measured: at 12 weeks

  3. 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.

    Measured: at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2023
  2. Study start12 Sep 2023
  3. Primary completion17 Jan 2025
  4. Study completion13 Feb 2025

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06050395
Sponsor's protocol ID
MCC-22523
Status last verified
Jun 2026
First submitted
11 Sep 2023
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Quality fo Life Questionnaire (FHSI), Vioscreen Food Frequency Questionnaire (FFQ) and Educational Handouts in people with Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

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 8 inclusion and 6 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: finished, as of the sponsor's last update on 26 Jun 2026. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate -Feasibility (time frame: Up to 8 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06050395.

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 26 Jun 2026.

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