Pancreatic CancerSTRONG-PCSNCT06001268
Support Through Remote Observation and Nutrition Guidance Program (STRONG-PCS)
A study testing Fitbit Data Collection, Nutrition Counseling and 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 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. 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 Survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2023to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- Determined to be ineligible for surgery during evaluation (e.g., cancer metastasis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Support Through Remote Observation and Nutrition Guidance Program for Individuals With Pancreatic Cancer Undergoing Surgery (STRONG-PCS)
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Fitbit Data Collection, Nutrition Counseling, Survey
- Keywords
- Nutrition 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, bi-weekly nutrition counseling from a dietician via telehealth or in person.
SurveyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Fitbit Data Collection; Behavioral: Nutrition Counseling; Behavioral: Survey |
| Usual Care | Active comparator | Participants will be referred for nutrition counseling from a dietitian based on clinical discretion. Receives: Behavioral: Nutrition Counseling; Behavioral: Survey |
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 enrolled.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: at 8 weeks
Secondary outcomes (6)
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.
Measured: 90 days
Malnutrition - Low BMI
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: at Baseline, 30, 60 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start14 Aug 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Kea Turner, PhD, Principal investigator, Moffitt Cancer CenterPamela J Hodul, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001268
- Sponsor's protocol ID
- MCC-22476
- Acronym
- STRONG-PCS
- Status last verified
- Jun 2026
- First submitted
- 14 Aug 2023
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41605580
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support Through Remote Observation and Nutrition Guidance Program for Individuals With Pancreatic Cancer Undergoing Surgery (STRONG-PCS)
- ClinicalTrials.gov ID
- NCT06001268
- Acronym / sponsor ID
- STRONG-PCS / MCC-22476
- Conditions
- Pancreatic Cancer
- Keywords
- Nutrition Support
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 21 Aug 2023 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STRONG-PCS Intervention | Experimental | Behavioral: Fitbit Data Collection, Behavioral: Nutrition Counseling, Behavioral: SurveyParticipants 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. |
| Usual Care | Active comparator | Behavioral: Nutrition Counseling, Behavioral: SurveyParticipants will be referred for nutrition counseling from a dietitian based on clinical discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (1 listed)
- Determined to be ineligible for surgery during evaluation (e.g., cancer metastasis)
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 | STRONG-PCS Intervention |
| Nutrition CounselingParticipants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person. | Behavioural | STRONG-PCS Intervention, Usual Care |
| SurveyParticipants 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. | Behavioural | STRONG-PCS Intervention, Usual Care |
Primary outcome
Recruitment Rate - Feasibility
Time frame: Up to 48 months
The study will be deemed feasible if ≥ 50% of eligible participants are enrolled.
Retention Rate - Feasibility
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
6 secondary outcomes
Malnutrition-Significant weight loss
Time frame: 90 days
Malnutrition - Low BMI
Time frame: at Baseline, 30, 60 and 90 days
Malnutrition - Low Skeletal Muscle Mass
Time frame: At baseline, 30, 60 and 90 days
Quality of Life
Time frame: at Baseline, 4, 8 and 12 weeks
Hospital Readmissions
Time frame: 30, 60 and 90 days post-hospital discharge
Malnutrition -Nutritional Status
Time frame: at Baseline, 30, 60 and 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Derived from this study: PubMed 41605580Turner 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.
- 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.
Kea Turner, PhD principal investigator
Moffitt Cancer Center
Pamela J 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 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 6 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 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?
This study is still under way. Results are not available in the source record yet.
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: Up to 48 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06001268, which also lists 1 linked publication.
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 2 Jul 2026.