Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

Sponsors

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

Collaborator: Canopy Cancer Collective

Source H. Lee Moffitt Cancer Center and Research Institute
Brief 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.

Overall Status Recruiting
Start Date 2022-06-22
Completion Date 2023-07-01
Primary Completion Date 2023-07-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Recruitment Rate - Feasibility 12 Months
Data Collection - Feasibility 12 Months
Participant Rating on Ease of Use for the Mobile Application - Usability 12 Months
Secondary Outcome
Measure Time Frame
Participant Compliance with Palliative Care Visits - Intervention Adherence 12 Months
Participant Compliance with Dietician Visits - Intervention Adherence 12 Months
Participant Compliance with Dietary Log - Intervention Adherence 12 Months
Enrollment 50
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Fitbit Data Collection

Description: Participants will log food intake while sharing their data with a dietician in real time for 12 weeks

Arm Group Label: Nutritional Support

Intervention Type: Behavioral

Intervention Name: Nutrition Counseling

Description: Participants will receive individually tailored, biweekly nutrition counseling from a dietician via telehealth

Arm Group Label: Nutritional Support

Intervention Type: Behavioral

Intervention Name: Fact G Survey

Description: 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.

Arm Group Label: Nutritional Support

Intervention Type: Behavioral

Intervention Name: General Anxiety Disorder (GAD)-7

Description: 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.

Arm Group Label: Nutritional Support

Intervention Type: Behavioral

Intervention Name: Patient Health Questionnaire (PHQ)-9

Description: 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.

Arm Group Label: Nutritional Support

Eligibility

Criteria:

Inclusion Criteria: - ≥18 years old - Newly diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer - Planning to initiate chemotherapy at Moffitt - Able to speak and read English - 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 secondary primary 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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Alina Hoehn

Phone: 813-745-7639

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Moffitt Cancer Center Alina Hoehn 813-745-7639 [email protected] Kea Turner, PhD, MPH, MA Principal Investigator Pamela Hodul, MD Principal Investigator Sahana Rajasekhara, MD Sub-Investigator James Costello, MD, PhD Sub-Investigator Jason Fleming, MD, FACS Sub-Investigator Brian Gonzalez, PhD Sub-Investigator Sarah Hoffe, MD Sub-Investigator Dae Won Kim, MD Sub-Investigator Richard Kim, MD Sub-Investigator Jenny Permuth, PhD Sub-Investigator
Location Countries

United States

Verification Date

2022-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Nutritional Support

Type: Experimental

Description: Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing data with a dietician

Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on Fitbit Data Collection