Pancreatic CancerEarly Phase 1NCT06323291
Cancer Coaching and Remote Education for Self-Empowerment (CARES) Study
A Early Phase 1 study testing Coaching Sessions in people with Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This Pilot Study will evaluate a 12-week pilot program that offers digital health coaching for individuals with pancreatic cancer and their caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Coaching Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 26 May 2025
- Phase
- Early Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Participant must have a pancreatic cancer diagnosis or be a caregiver such as a friend or spouse.
- Participant must be planning to receive treatment and/or care management at Moffitt Cancer Center.
- Participant must be able to speak and read English.
- Participant must be able to provide informed consent.
Who cannot join
- Documented or observable psychiatric or neurological disorder that would interfere with study participation such as severe dementia
- Any participant that does not meet all inclusion criteria will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
This Pilot Study will evaluate a 12-week pilot program that offers digital health coaching for individuals with pancreatic cancer and their caregivers.
- Conditions
- Pancreatic Cancer
- Being tested
- Coaching Sessions
- Keywords
- Pancreas, Pancreatic Cancer, Caregiver
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching SessionsBehavioural
Enrolled participants will set up an account through a secure and encrypted web portal managed by Osara Health.
Coaches will follow-up with their designated patients and/or caregivers to schedule individual coaching sessions via phone, text, or email depending on the participant's communication preference. Participants will have an initial coaching consultation by phone to go over the purpose and structure of coaching sessions.
Participants will then have an additional 3-4 coaching sessions (depending on time availability and need) to discuss symptom management, nutrition and exercise, sleep, and mindfulness.
Participants will receive content for each of the modules via email.
| Study group | Role | What they receive |
|---|---|---|
| Digital Health Coaching for Pancreatic Cancer Patients | Other | Initial in-person and/or virtual supportive care, social work, and dietitian consultation within 4 weeks of diagnosis and/or 3 weeks of study enrollment. Receives: Behavioral: Coaching Sessions |
| Digital Health Coaching for Caregivers | Other | Initial in-person and/or virtual supportive care, social work, and dietitian consultation within 4 weeks of diagnosis and/or 3 weeks of study enrollment. Receives: Behavioral: Coaching Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Measured by ≥ 50% of eligible participants recruited.
Measured: Up to 12 Months
Participant Acceptance of the Digital Health Coaching Program
Measured by ≥ 70% of participant rating of the intervention as satisfactory. 4 item scale (score range 0-20) will be utilized.
Measured: Up to 12 Weeks
Participant Ease of Usability of the Digital Health Coaching Program
Measured by ≥ 70% of participant rating the mobile application as easy-to-use for scheduling coaching visits.
4 item scale (score range 0-20) will be utilized.
Measured: Up to 12 Weeks
Feasibility of Utilizing the Digital Health Coaching Program
Measured by ≥ 70% of participant rating of being likely to utilize the intervention.
4 item scale (score range 0-20) will be utilized.
Measured: Up to 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Apr 2024
- Primary completion26 May 2025
- Study completion26 May 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT06323291
- Sponsor's protocol ID
- MCC-23077
- Status last verified
- Sep 2026
- First submitted
- 14 Mar 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Coaching and Remote Education for Self-Empowerment (CARES) Study
- ClinicalTrials.gov ID
- NCT06323291
- Acronym / sponsor ID
- MCC-23077
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreas, Pancreatic Cancer, Caregiver
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Canopy Cancer Collective, LLC
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 21 Mar 2024 (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.
This Pilot Study will evaluate a 12-week pilot program that offers digital health coaching for individuals with pancreatic cancer and their caregivers.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Health Coaching for Pancreatic Cancer Patients | Other | Behavioral: Coaching SessionsInitial in-person and/or virtual supportive care, social work, and dietitian consultation within 4 weeks of diagnosis and/or 3 weeks of study enrollment. |
| Digital Health Coaching for Caregivers | Other | Behavioral: Coaching SessionsInitial in-person and/or virtual supportive care, social work, and dietitian consultation within 4 weeks of diagnosis and/or 3 weeks of study enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older.
- Participant must have a pancreatic cancer diagnosis or be a caregiver such as a friend or spouse.
- Participant must be planning to receive treatment and/or care management at Moffitt Cancer Center.
- Participant must be able to speak and read English.
- Participant must be able to provide informed consent.
Key exclusion criteria (2 listed)
- Documented or observable psychiatric or neurological disorder that would interfere with study participation such as severe dementia
- Any participant that does not meet all inclusion criteria will be excluded.
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 |
|---|---|---|
| Coaching SessionsEnrolled participants will set up an account through a secure and encrypted web portal managed by Osara Health. Coaches will follow-up with their designated patients and/or caregivers to schedule individual coaching sessions via phone, text, or email depending on the participant's communication preference. Participants will have an initial coaching consultation by phone to go over the purpose and structure of coaching sessions. Participants will then have an additional 3-4 coaching sessions (depending on time availability and need) to discuss symptom management, nutrition and exercise, sleep, and mindfulness. Participants will receive content for each of the modules via email. | Behavioural | Digital Health Coaching for Caregivers, Digital Health Coaching for Pancreatic Cancer Patients |
Primary outcome
Recruitment Rate
Time frame: Up to 12 Months
Measured by ≥ 50% of eligible participants recruited.
Participant Acceptance of the Digital Health Coaching Program
Time frame: Up to 12 Weeks
Measured by ≥ 70% of participant rating of the intervention as satisfactory. 4 item scale (score range 0-20) will be utilized.
Participant Ease of Usability of the Digital Health Coaching Program
Time frame: Up to 12 Weeks
Measured by ≥ 70% of participant rating the mobile application as easy-to-use for scheduling coaching visits. 4 item scale (score range 0-20) will be utilized.
Feasibility of Utilizing the Digital Health Coaching Program
Time frame: Up to 12 Weeks
Measured by ≥ 70% of participant rating of being likely to utilize the intervention. 4 item scale (score range 0-20) will be utilized.
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 23 Sep 2026.
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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 Early Phase 1 study testing Coaching Sessions 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 2 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 23 Sep 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: Up to 12 Months). The study lists 4 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 23 Sep 2026.