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

H. Lee Moffitt Cancer Center and Research Institute

Status: Active, not recruiting

Conditions: Pancreatic Cancer

Treatments: Behavioral: Educational Handouts; Behavioral: Follow-Up Survey; Behavioral: NutritionCoaching; Behavioral: Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire; Behavioral: Quality fo Life Questionnaire (FHSI); Behavioral: Vioscreen Food Frequency Questionnaire (FFQ); Behavioral: Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT06050395

MCC-22523

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response

Experimental group

Description:

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.

Treatment:

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

Behavioral: Vioscreen Food Frequency Questionnaire (FFQ)

Behavioral: Quality fo Life Questionnaire (FHSI)

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

Behavioral: NutritionCoaching

Behavioral: Follow-Up Survey

Standard Usual Care

Active Comparator group

Description:

Standard Usual Care participants will receive usual nutrition care received in the Moffitt Cancer Center pancreatic clinic, in addition to handouts on diet.

Treatment:

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

Behavioral: Quality fo Life Questionnaire (FHSI)

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

Behavioral: Follow-Up Survey

Behavioral: Educational Handouts