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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STRONG-PCS Intervention | Experimental | Participants will receive an initial in-person consultation with a dietician within 2 weeks of hospital discharge. Then participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician. |
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| Usual Care | Active Comparator | Participants will be referred for nutrition counseling from a dietitian based on clinical discretion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit Data Collection | Behavioral | Participants will log food intake while sharing their data with a dietician in real time for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate - Feasibility | The study will be deemed feasible if ≥ 50% of eligible participants are enrolled. | Up to 48 months |
| Retention Rate - Feasibility | The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks. | at 8 weeks |
| Data Collection - Feasibility | The study will be deemed feasible if ≥ 70% of participants log food for greater than 80% of study days. | at 8 weeks |
| Participant Satisfaction - Acceptability | 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). | at 8 weeks |
| Participant Rating on Ease of Use 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 using a validated 10-item scale (score range from 0-100, score of >/=60). | at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Malnutrition-Significant weight loss | 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. | 90 days |
| Malnutrition - Low BMI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kea Turner, PhD | Moffitt Cancer Center | Principal Investigator |
| Pamela J Hodul, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41605580 | Derived | Turner K, Milano J, Santiago C, Coutinho J, Sprow O, Hume E, Nardella N, Alishahi Tabriz A, Islam JY, Hodul PJ. A patient-mediated strategy to improve nutrition care after transition from hospital to home for pancreatic cancer surgery: a pilot randomised controlled trial study protocol. BMJ Open. 2026 Jan 28;16(1):e113207. doi: 10.1136/bmjopen-2025-113207. |
| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trial Search | View source |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Nutrition Counseling | Behavioral | Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person. |
|
| Survey | Behavioral | 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. |
|
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.
| at Baseline, 30, 60 and 90 days |
| Malnutrition - Low Skeletal Muscle Mass | 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. | At baseline, 30, 60 and 90 days |
| Quality of Life | 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. | at Baseline, 4, 8 and 12 weeks |
| Hospital Readmissions | 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. | 30, 60 and 90 days post-hospital discharge |
| Malnutrition -Nutritional Status | 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). | at Baseline, 30, 60 and 90 days |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |