Pancreatic Cancer
Conditions
Keywords
Nutrition Support
Brief summary
The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance program. The program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are undergoing surgery.
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, bi-weekly nutrition counseling from a dietician via telehealth or in person.
BEHAVIORALSurvey
Participants will take a survey at baseline and weeks 4,8,\& 12. (FACT-G) 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.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years old * Diagnosis of pancreatic cancer * Completed open pancreatic surgery (e.g., Whipple, distal/subtotal pancreatectomy, total pancreatectomy) for treatment at Moffitt Cancer Center * Discharged on an oral diet * Able to speak and read English or Spanish * Able to provide informed consent
Exclusion criteria
* Determined to be ineligible for surgery during evaluation (e.g., cancer metastasis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate - Feasibility | Up to 48 months | The study will be deemed feasible if ≥ 50% of eligible participants are enrolled. |
| Retention Rate - Feasibility | at 8 weeks | The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks. |
| Data Collection - Feasibility | at 8 weeks | The study will be deemed feasible if ≥ 70% of participants log food for greater than 80% of study days. |
| Participant Satisfaction - Acceptability | at 8 weeks | The study will be deemed acceptable if ≥ 70% of participants rate the overall intervention as satisfactory using a validated 4-item scale (score range 0-20, score \>/= 12). |
| Participant Rating on Ease of Use the Mobile Application - Usability | at 8 weeks | The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake using a validated 10-item scale (score range from 0-100, score of \>/=60). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Malnutrition-Significant weight loss | 90 days | Significant weight loss is defined as \>5% and \>10% of body weight at 30, 60, and 90 days after discharge. This will be calculated based on weight obtained during clinic visits. |
| Malnutrition - Low BMI | at Baseline, 30, 60 and 90 days | Low BMI will be defined as \<20kg/m² for individuals \<70 years old and \<22kg/m2 for individuals ≥70 years old. This will be calculated based on weight and height measurements from clinic visits. |
| Malnutrition - Low Skeletal Muscle Mass | At baseline, 30, 60 and 90 days | Low muscle mass will be estimated by calculating skeletal muscle index (SMI) from routinely collected CT scans at baseline and 90 days after discharge (CT scans are conducted every 3 months). Low muscle mass will be defined as SMI ≤38.9 cm2 /m2 for females and SMI ≤55.4 cm2 /m2 for males. |
| Quality of Life | at Baseline, 4, 8 and 12 weeks | Quality of Life will be measured using the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire includes questions about the 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 score indicates a better quality of life. |
| Hospital Readmissions | 30, 60 and 90 days post-hospital discharge | Hospital readmissions will be measured using a self-reported survey item to determine whether the patient was admitted to the index hospital or another hospital after hospital discharge. |
| Malnutrition -Nutritional Status | at Baseline, 30, 60 and 90 days | Nutritional status will be measured using the Patient-Generated Subjective Global Assessment (PG-SGA) Short Form (score range: 0-35) and categorized based on a prior validation study (0-1 well nourished, 2-8 at-risk, = 9 severely malnourished). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKea Turner, PhD
Moffitt Cancer Center
PRINCIPAL_INVESTIGATORPamela J Hodul, MD
Moffitt Cancer Center
Outcome results
None listed