Pancreatic Cancer
Conditions
Keywords
Nutritional Support
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.
Interventions
BEHAVIORALFitbit Data Collection
Participants will log food intake while sharing their data with a dietician in real time for 12 weeks
BEHAVIORALNutrition Counseling
Participants will receive individually tailored, biweekly nutrition counseling from a dietician via telehealth
BEHAVIORALFact 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.
BEHAVIORALGeneral 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.
BEHAVIORALPatient 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.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Canopy Cancer Collective
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate - Feasibility | 12 Months | The study will be deemed feasible if ≥ 50% of eligible participants are recruited |
| Data Collection - Feasibility | 12 Months | The study will be deemed feasible if ≥ 50% of participants submit study assessments |
| Participant Rating on Ease of Use for the Mobile Application - Usability | 12 Months | The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Compliance with Palliative Care Visits - Intervention Adherence | 12 Months | Intervention adherence will be deemed successful if ≥ 60% of participants attend recommended palliative care visits (# of visits based on provider recommendation) |
| Participant Compliance with Dietician Visits - Intervention Adherence | 12 Months | Intervention adherence will be deemed successful if ≥ 60% of participants meet with a dietician biweekly for 12 weeks |
| Participant Compliance with Dietary Log - Intervention Adherence | 12 Months | Intervention adherence will be deemed successful if ≥ 60% of participants rack food intake for 8/12 weeks |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmir Alishahi Tabriz, MD, PhD
Moffitt Cancer Center
PRINCIPAL_INVESTIGATORPamela Hodul, MD
Moffitt Cancer Center
Outcome results
None listed