Pancreatic CancerNCT05675059
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients
A study testing Consultations with Moffitt Dietician, Daily Food Intake Diary with Fitbit Smartphone application and Questionnaires 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 (STRONG) program. The program provides enhanced dietician access and nutrition support 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?
- Consultations with Moffitt Dietician, Daily Food Intake Diary with Fitbit Smartphone application and Questionnaires
- 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
- 21 Dec 2022to 11 May 2026
- 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 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
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
- Use of parenteral or enteral nutrition
- Presence of malignant ascites
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Consultations with Moffitt Dietician, Daily Food Intake Diary with Fitbit Smartphone application, Questionnaires
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consultations with Moffitt DieticianBehavioural
Participants will have an initial consultation and then biweekly follow-up visits (in-person or virtually) with a study dietician for 12 weeks.
Daily Food Intake Diary with Fitbit Smartphone applicationBehavioural
Participants will keep a daily diary of food intake with a Fitbit smartphone app and wearing a Fitbit for 12 weeks.
QuestionnairesBehavioural
Participants will complete a questionnaire electronically at baseline and again at 4, 8, 12 and 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: STRONG Intervention | Active comparator | The STRONG program includes consultation with a Moffit dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires. Receives: Behavioral: Consultations with Moffitt Dietician; Behavioral: Daily Food Intake Diary with Fitbit Smartphone application; Behavioral: Questionnaires |
| Group 2: Usual Care | Active comparator | Participants will be referred to dieticians based on clinical discretion. Participants will also be asked to wear a Fitbit for 12 weeks to passively collect data on activity level. Receives: Behavioral: Consultations with Moffitt Dietician; Behavioral: Daily Food Intake Diary with Fitbit Smartphone application; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the STRONG Program
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.
Measured: at 12 weeks
Acceptability of the STRONG Program
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.
Measured: at 16 weeks
Participant adherence to the STRONG Program
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.
Measured: Up to 90 days
Malnutrition: Significant Weight Loss
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.
Measured: at 16 weeks
Malnutrition: Low BMI
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.
Measured: at 16 weeks
Malnutrition: Low Skeletal Muscle Mass
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.
Measured: at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start21 Dec 2022
- Primary completion22 Nov 2025
- Study completion11 May 2026
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
- Pancreatic Cancer Action Network
- Responsible party
- Sponsor
- Investigators
- Amir Alishahi Tabriz, MD, PhD, MPH, Principal investigator, Moffitt Cancer CenterPamela Hodul, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675059
- Sponsor's protocol ID
- MCC-22082
- Status last verified
- Jul 2026
- First submitted
- 9 Dec 2022
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Turner K, Kim DW, Gonzalez BD, Gore LR, Gurd E, Milano J, Riccardi D, Byrne M, Al-Jumayli M, de Castria TB, Laber DA, Hoffe S, Costello J, Robinson E, Chadha JS, Rajasekhara S, Hume E, Hagen R, Nguyen OT, Nardella N, Parker N, Carson TL, Tabriz AA, Hodul P. Support Through Remote Observation and Nutrition Guidance (STRONG), a digital health intervention to reduce malnutrition among pancreatic cancer patients: A study protocol for a pilot randomized controlled trial. Contemp Clin Trials Commun. 2024 Feb 23;38:101271. doi: 10.1016/j.conctc.2024.101271. eCollection 2024 Apr.
PubMed 38440777
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients
- ClinicalTrials.gov ID
- NCT05675059
- Acronym / sponsor ID
- MCC-22082
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Pancreatic Cancer Action Network
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 22 Nov 2025 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 9 Jan 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 (STRONG) program. The program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are receiving chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: STRONG Intervention | Active comparator | Behavioral: Consultations with Moffitt Dietician, Behavioral: Daily Food Intake Diary with Fitbit Smartphone application, Behavioral: QuestionnairesThe STRONG program includes consultation with a Moffit dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires. |
| Group 2: Usual Care | Active comparator | Behavioral: Consultations with Moffitt Dietician, Behavioral: Daily Food Intake Diary with Fitbit Smartphone application, Behavioral: QuestionnairesParticipants will be referred to dieticians based on clinical discretion. Participants will also be asked to wear a Fitbit for 12 weeks to passively collect data on activity level. |
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 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
Key exclusion criteria (5 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
- Use of parenteral or enteral nutrition
- Presence of malignant ascites
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 |
|---|---|---|
| Consultations with Moffitt DieticianParticipants will have an initial consultation and then biweekly follow-up visits (in-person or virtually) with a study dietician for 12 weeks. | Behavioural | Group 1: STRONG Intervention, Group 2: Usual Care |
| Daily Food Intake Diary with Fitbit Smartphone applicationParticipants will keep a daily diary of food intake with a Fitbit smartphone app and wearing a Fitbit for 12 weeks. | Behavioural | Group 1: STRONG Intervention, Group 2: Usual Care |
| QuestionnairesParticipants will complete a questionnaire electronically at baseline and again at 4, 8, 12 and 16 weeks. | Behavioural | Group 1: STRONG Intervention, Group 2: Usual Care |
Primary outcome
Feasibility of the STRONG Program
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
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 30 Jul 2026.
- Derived from this study: PubMed 38440777Turner K, Kim DW, Gonzalez BD, Gore LR, Gurd E, Milano J, Riccardi D, Byrne M, Al-Jumayli M, de Castria TB, Laber DA, Hoffe S, Costello J, Robinson E, Chadha JS, Rajasekhara S, Hume E, Hagen R, Nguyen OT, Nardella N, Parker N, Carson TL, Tabriz AA, Hodul P. Support Through Remote Observation and Nutrition Guidance (STRONG), a digital health intervention to reduce malnutrition among pancreatic cancer patients: A study protocol for a pilot randomized controlled trial. Contemp Clin Trials Commun. 2024 Feb 23;38:101271. doi: 10.1016/j.conctc.2024.101271. eCollection 2024 Apr.
- 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, MPH 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 Consultations with Moffitt Dietician, Daily Food Intake Diary with Fitbit Smartphone application and Questionnaires 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 5 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 30 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?
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?
Feasibility of the STRONG Program (time frame: at 12 weeks). The study lists 6 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 NCT05675059, 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 30 Jul 2026.