Pancreatic CancerNCT05438927
Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer
A study testing Fitbit Data Collection, Nutrition Counseling and Fact G Survey in people with Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Fitbit Data Collection, Nutrition Counseling and Fact G Survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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 exclusion criteria were included because investigators do not anticipate that these patients would benefit from additional nutrition intervention.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Fitbit Data Collection, Nutrition Counseling, Fact G Survey, General Anxiety Disorder (GAD)-7, Patient Health Questionnaire (PHQ)-9
- Keywords
- Nutritional Support
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit Data CollectionBehavioural
Participants will log food intake while sharing their data with a dietician in real time for 12 weeks
Nutrition CounselingBehavioural
Participants will receive individually tailored, biweekly nutrition counseling from a dietician via telehealth
Fact G SurveyBehavioural
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)-7Behavioural
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)-9Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Fitbit Data Collection; Behavioral: Nutrition Counseling; Behavioral: Fact G Survey; Behavioral: General Anxiety Disorder (GAD)-7; Behavioral: Patient Health Questionnaire (PHQ)-9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate - Feasibility
The study will be deemed feasible if ≥ 50% of eligible participants are recruited
Measured: 12 Months
Data Collection - Feasibility
The study will be deemed feasible if ≥ 50% of participants submit study assessments
Measured: 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
Measured: 12 Months
Secondary outcomes (3)
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)
Measured: 12 Months
Participant Compliance with Dietician Visits - Intervention Adherence
Intervention adherence will be deemed successful if ≥ 60% of participants meet with a dietician biweekly for 12 weeks
Measured: 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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start15 Jul 2022
- Primary completion16 Oct 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Canopy Cancer Collective, LLC
- Responsible party
- Sponsor
- Investigators
- Amir Alishahi Tabriz, MD, PhD, Principal investigator, Moffitt Cancer CenterPamela Hodul, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438927
- Sponsor's protocol ID
- MCC-21795
- Status last verified
- Mar 2026
- First submitted
- 27 Jun 2022
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05438927
- Acronym / sponsor ID
- MCC-21795
- Conditions
- Pancreatic Cancer
- Keywords
- Nutritional Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Canopy Cancer Collective, LLC
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional Support | Experimental | Behavioral: Fitbit Data Collection, Behavioral: Nutrition Counseling, Behavioral: Fact G Survey, Behavioral: General Anxiety Disorder (GAD)-7, Behavioral: Patient Health Questionnaire (PHQ)-9Participants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit Data CollectionParticipants will log food intake while sharing their data with a dietician in real time for 12 weeks | Behavioural | Nutritional Support |
| Nutrition CounselingParticipants will receive individually tailored, biweekly nutrition counseling from a dietician via telehealth | Behavioural | Nutritional Support |
| Fact G SurveyParticipants 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. | Behavioural | Nutritional Support |
| General Anxiety Disorder (GAD)-7Participants 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. | Behavioural | Nutritional Support |
| Patient Health Questionnaire (PHQ)-9Participants 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. | Behavioural | Nutritional Support |
Primary outcome
Recruitment Rate - Feasibility
Time frame: 12 Months
The study will be deemed feasible if ≥ 50% of eligible participants are recruited
Data Collection - Feasibility
Time frame: 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
Time frame: 12 Months
The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake
3 secondary outcomes
Participant Compliance with Palliative Care Visits - Intervention Adherence
Time frame: 12 Months
Participant Compliance with Dietician Visits - Intervention Adherence
Time frame: 12 Months
Participant Compliance with Dietary Log - Intervention Adherence
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Alishahi Tabriz, MD, PhD principal investigator
Moffitt Cancer Center
Pamela Hodul, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit Data Collection, Nutrition Counseling and Fact G Survey in people with Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate - Feasibility (time frame: 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.