The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response
- Conditions
- Pancreatic Cancer
- Interventions
- Behavioral: Quality fo Life Questionnaire (FHSI)Behavioral: Vioscreen Food Frequency Questionnaire (FFQ)Behavioral: Educational HandoutsBehavioral: NutritionCoachingBehavioral: Follow-Up SurveyBehavioral: Functional Assessment of Anorexia/Cachexia Treatment (FAACT) QuestionnaireBehavioral: Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire
- Registration Number
- NCT06050395
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Usual Care Quality fo Life Questionnaire (FHSI) Standard Usual Care participants will receive usual nutrition care received in the Moffitt Cancer Center pancreatic clinic, in addition to handouts on diet. MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response NutritionCoaching 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. MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response Quality fo Life Questionnaire (FHSI) 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. MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response Vioscreen Food Frequency Questionnaire (FFQ) 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. MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response Follow-Up Survey 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. MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire 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. MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire 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. Standard Usual Care Educational Handouts Standard Usual Care participants will receive usual nutrition care received in the Moffitt Cancer Center pancreatic clinic, in addition to handouts on diet. Standard Usual Care Follow-Up Survey Standard Usual Care participants will receive usual nutrition care received in the Moffitt Cancer Center pancreatic clinic, in addition to handouts on diet. Standard Usual Care Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire Standard Usual Care participants will receive usual nutrition care received in the Moffitt Cancer Center pancreatic clinic, in addition to handouts on diet. Standard Usual Care Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire Standard Usual Care participants will receive usual nutrition care received in the Moffitt Cancer Center pancreatic clinic, in addition to handouts on diet.
- Primary Outcome Measures
Name Time Method Retention Rate - Feasibility at 12 weeks The study will be deemed feasible if \>/=70% of participants complete the post-intervention questionnaire
Recruitment Rate -Feasibility Up to 8 months The study will be deemed feasible if \>/= 60% of eligible participants are enrolled
Adherence - Feasibility 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
Name Time Method Participant intent to continue using skills- Acceptability 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.
Participant Satisfaction with Overall Program- Acceptability 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.
Participant perception of utility of knowledge gained - Acceptability 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.
Trial Locations
- Locations (1)
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States