Pancreatic Cancer
Conditions
Brief summary
The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are receiving chemotherapy.
Interventions
BEHAVIORALConsultations with Moffitt Dietician
Participants will have an initial consultation and then biweekly follow-up visits (in-person or virtually) with a study dietician for 12 weeks.
Participants will keep a daily diary of food intake with a Fitbit smartphone app and wearing a Fitbit for 12 weeks.
BEHAVIORALQuestionnaires
Participants will complete a questionnaire electronically at baseline and again at 4, 8, 12 and 16 weeks.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Pancreatic Cancer Action Network
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 of age or older * Diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer * Receiving chemotherapy under the guidance of 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 second primary GI cancer * ECOG status of 2 or greater * Use of parenteral or enteral nutrition * Presence of malignant ascites
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the STRONG Program | at 12 weeks | Feasibility of the Support through Remote Observation and Nutrition Guidance (STRONG) program will be assessed using recruitment and retention rates, along with data completion rates. |
| Acceptability of the STRONG Program | at 16 weeks | Acceptability of the STRONG Program measure uses 4 items to indicate participant satisfaction. The measure uses a scale of 0-5, 0 meaning the participant completely disagrees with the statements regarding intervention satisfaction and 5 indicating complete agreement with the statements regarding intervention satisfaction. The measure score ranges from 0-20 with 20 indicating the highest degree of satisfaction. |
| Participant adherence to the STRONG Program | Up to 90 days | will be defined as ≥ 60% of patients will meet with a dietician for 4/6 dietician visits and ≥ 60% of patients will track daily food intake via a Fitbit. |
| Malnutrition: Significant Weight Loss | at 16 weeks | Significant weight loss will be defined as a loss of \>5% and \>10% of body weight over the 16 week assessment period. Weight will be measured in kg. |
| Malnutrition: Low BMI | at 16 weeks | Low BMI will be calculated by combining weight (kg) and height measurements (m²) and defined as \<20kg/m² for adults \< 70 years old and \<22kg/m² for adults ≥ 70 years old over the 16 week assessment period. |
| Malnutrition: Low Skeletal Muscle Mass | at 16 weeks | Low skeletal muscle mass will be calculated by estimating skeletal muscle index (SMI) by dividing the cross-sectional area of muscle in a single 'slice' from an abdominal CT scan (cm2) by stature (square of height in m²). Low SMI will be defined as ≤38.9 cm2/m2 for females and ≤55.4 for males over the 16 week assessment period. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmir Alishahi Tabriz, MD, PhD, MPH
Moffitt Cancer Center
PRINCIPAL_INVESTIGATORPamela Hodul, MD
Moffitt Cancer Center
Outcome results
None listed