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| Name | Class |
|---|---|
| Canopy Cancer Collective | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional Support | Experimental | Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing data with a dietician |
|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate - Feasibility | The study will be deemed feasible if ≥ 50% of eligible participants are recruited | 12 Months |
| Data Collection - Feasibility | The study will be deemed feasible if ≥ 50% of participants submit study assessments | 12 Months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Participant Compliance with Dietician Visits - Intervention Adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amir Alishahi Tabriz, MD, PhD | Moffitt Cancer Center | Principal Investigator |
| Pamela Hodul, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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| Nutrition Counseling | Behavioral | Participants will receive individually tailored, biweekly nutrition counseling from a dietician via telehealth |
|
| Fact G Survey | Behavioral | 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 | Behavioral | 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 | Behavioral | 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. |
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Intervention adherence will be deemed successful if ≥ 60% of participants meet with a dietician biweekly for 12 weeks |
| 12 Months |
| 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 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000073222 | Patient Health Questionnaire |
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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