The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response
- Conditions
- Pancreatic Cancer
- 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
- 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
Moffitt Cancer Center🇺🇸Tampa, Florida, United States