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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06050395
• Other study ID #: MCC-22523
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer

Intervention

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.
• 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.
• Educational Handouts
Participants will receive educational handouts on diet.
• NutritionCoaching
Participants will receive bi-weekly nutrition coaching on anti-inflammatory dietary patterns and foods.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Effect - Quality of Life	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.	at Baseline, and at 6 and 12 weeks
Primary	Recruitment Rate -Feasibility	The study will be deemed feasible if >/= 60% of eligible participants are enrolled	Up to 8 months
Primary	Retention Rate - Feasibility	The study will be deemed feasible if >/=70% of participants complete the post-intervention questionnaire	at 12 weeks
Primary	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	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
Secondary	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
Secondary	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

External Links

•   Moffitt Cancer Center Clinical Trials website