Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05438927
• Other study ID #: MCC-21795
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: July 2024

Study information

• Verified date: March 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 assess the feasibility and patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition and supportive care for participants living with pancreatic cancer who are receiving chemotherapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years old
• Newly diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer
• Planning to initiate chemotherapy under the guidance of Moffitt
• Able to speak and read English or Spanish
• Able to provide informed consent

Exclusion Criteria:

• Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse)
• Undergoing concurrent treatment for a second primary GI cancer
• ECOG status of 2 or greater
• Receipt of chemotherapy in the past 6 months for recurrent pancreatic cancer
• Use of parenteral or enteral nutrition
• Presence of malignant ascites
• The last two exclusion criteria were included because investigators do not anticipate that these patients would benefit from additional nutrition intervention.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Behavioral:
• Fitbit Data Collection
Participants will log food intake while sharing their data with a dietician in real time for 12 weeks
• Nutrition Counseling
Participants will receive individually tailored, biweekly nutrition counseling from a dietician via telehealth
• Fact G Survey
Participants will take a survey at baseline and weeks 4,8,12 & 16. The questionnaire includes questions about participant's physical, social, emotional and functional well being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher total score indicates better quality of life.
• General Anxiety Disorder (GAD)-7
Participants will take a survey at baseline and weeks 4,8,12 & 16. The questionnaire measures participants anxiety with a scale of 0=not at all, 3=Nearly everyday.
• Patient Health Questionnaire (PHQ)-9
Participants will take a survey at baseline and weeks 4,8,12 & 16. The questionnaire measures participants depression with a scale of 0=not at all, 3=Nearly everyday.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate - Feasibility	The study will be deemed feasible if = 50% of eligible participants are recruited	12 Months
Primary	Data Collection - Feasibility	The study will be deemed feasible if = 50% of participants submit study assessments	12 Months
Primary	Participant Rating on Ease of Use for the Mobile Application - Usability	The study will be deemed usable if = 60% of participants rate the mobile application as easy-to-use for logging dietary intake	12 Months
Secondary	Participant Compliance with Palliative Care Visits - Intervention Adherence	Intervention adherence will be deemed successful if = 60% of participants attend recommended palliative care visits (# of visits based on provider recommendation)	12 Months
Secondary	Participant Compliance with Dietician Visits - Intervention Adherence	Intervention adherence will be deemed successful if = 60% of participants meet with a dietician biweekly for 12 weeks	12 Months
Secondary	Participant Compliance with Dietary Log - Intervention Adherence	Intervention adherence will be deemed successful if = 60% of participants rack food intake for 8/12 weeks	12 Months

External Links

•   Moffitt Cancer Center Clinical Trials Search