Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05438927
Other study ID # MCC-21795
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT05305001 - Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Recruiting NCT06054984 - TCR-T Cells in the Treatment of Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT04927780 - Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer Phase 3
Recruiting NCT05919537 - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation Phase 1
Terminated NCT03140670 - Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy Phase 2
Terminated NCT00529113 - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer Phase 1
Recruiting NCT05168527 - The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT05391126 - GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care N/A
Terminated NCT03300921 - A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer Phase 1
Completed NCT03153410 - Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas Early Phase 1
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Recruiting NCT05679583 - Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer Phase 2
Recruiting NCT04183478 - The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer Phase 2/Phase 3
Terminated NCT03600623 - Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Completed NCT04290364 - Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study