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

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ClinicalTrials.gov Identifier: NCT06050395
Recruitment Status : Recruiting
First Posted : September 22, 2023
Last Update Posted : February 14, 2024
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Behavioral: Quality fo Life Questionnaire (FHSI) Behavioral: Vioscreen Food Frequency Questionnaire (FFQ) Behavioral: Educational Handouts 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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response
Actual Study Start Date : September 12, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)
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.

Behavioral: Vioscreen Food Frequency Questionnaire (FFQ)
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.

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

Behavioral: Follow-Up Survey
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.

Behavioral: Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire
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.

Behavioral: Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire
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.
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)
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.

Behavioral: Educational Handouts
Participants will receive educational handouts on diet.

Behavioral: Follow-Up Survey
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.

Behavioral: Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire
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.

Behavioral: Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire
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.


Outcome Measures
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Primary Outcome Measures :
  1. Recruitment Rate -Feasibility [ Time Frame: Up to 8 months ]
    The study will be deemed feasible if >/= 60% of eligible participants are enrolled

  2. Retention Rate - Feasibility [ Time Frame: at 12 weeks ]
    The study will be deemed feasible if >/=70% of participants complete the post-intervention questionnaire

  3. Adherence - Feasibility [ Time Frame: at 12 weeks ]
    The study will be deemed feasible if average attendance is >/=4 weeks of sessions (out of 6) for MONITOR arm


Secondary Outcome Measures :
  1. Participant Satisfaction with Overall Program- Acceptability [ Time Frame: at 12 weeks ]
    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.

  2. Participant intent to continue using skills- Acceptability [ Time Frame: at 12 weeks ]
    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.

  3. Participant perception of utility of knowledge gained - Acceptability [ Time Frame: at 12 weeks ]
    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.


Other Outcome Measures:
  1. Treatment Effect - Quality of Life [ Time Frame: at Baseline, and at 6 and 12 weeks ]
    Quality of Life will be measured using the FACT-Hep questionnaire. Participants will take the Functional Assessment of Cancer Therapy Hepatobiliary Cancer Symptom 8 Item Version (FHSI) questionnaire which uses a 5-point likert-type scale, 0=not at all and 4=Very much. A lower total score indicates better quality of life.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06050395


Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Crystal Bryant, MPH    813-745-2168    Crystal.Bryant@moffitt.org   
Principal Investigator: Sylvia Crowder, PhD         
Principal Investigator: Pamela Hodul, MD         
Sub-Investigator: Laurence Gore, PhD         
Sub-Investigator: Heather Jim, PhD         
Sub-Investigator: Kea Turner, PhD, MPH, MA         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
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Principal Investigator: Sylvia Crowder, PhD Moffitt Cancer Center
Principal Investigator: Pamela Hodul, MD Moffitt Cancer Center
More Information
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Additional Information:

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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT06050395    
Other Study ID Numbers: MCC-22523
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: February 14, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No