Pancreatic Cancer, AdultNCT07591571
To Evaluate the Preliminary Efficacy of Our Digitally Enhanced CHW-led Intervention in Newly Diagnosed PDAC
A study testing PAL-CHW-PDAC in people with Pancreatic Cancer, Adult, run by Loma Linda University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a community health worker led intervention that helps facilitate palliative care works to treat newly-diagnostic pancreatic cancer. It will also help understand the impact of this intervention on people who are caregivers for patients with pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Pancreatic Cancer, Adult
- What is being tested?
- PAL-CHW-PDAC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 1 Oct 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 18 to 90
- English or Spanish-Speaking
- Diagnosed with Newly-Diagnosed Pancreatic Adenocarcinoma or has a pancreatic mass on CT/MRI with suspected PDAC and is awaiting biopsy.
- Able to communicate verbally to allow for audio recording to complete an exit interview
- Must be able to consent
Who cannot join
- Biopsy Does not Confirm Adenocarcinoma of the Pancreas
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Health
Loma Linda, California, 92886
About this study
Official title: To Evaluate the Preliminary Efficacy of Our Digitally Enhanced CHW-led Intervention in Newly Diagnosed PDAC With a Pilot Randomized Controlled Trial of 60 PDAC Patients and Their Caregivers Comparing the Intervention to Attention Control With Usual Care.
The goal of this clinical trial is to learn if a community health worker led intervention that helps facilitate palliative care works to treat newly-diagnostic pancreatic cancer. It will also help understand the impact of this intervention on people who are caregivers for patients with pancreatic cancer. The main questions it aims to answer are:
Does the community health worker improve symptoms and quality of life in patients with pancreatic cancer? Does the community health worker improve the burden of caregiving and quality of life in family caregivers? Researchers will compare drug ABC to a control (where patients get the care that patients with pancreatic cancer receive including access to handouts and videos that the investigators provide patients by national organizations) to see if the intervention works to help patients with pancreatic cancer.
Read more
Participants will:
Meet with study staff several times over 3 months and complete surveys about their experience and symptoms Patients assigned with the community health worker will meet with them in person or video.
Read the detailed description
- Overall study design
This will be a pilot randomized controlled trial where the investigators will plan on randomizing patients with PDAC in a 1:1 fashion to receive a digitally-enhanced community health worker intervention that will involve visits with the CHW and digital communication to facilitate care navigation and provide early palliative care engagement or usual care.
- Study Procedures and Schedule
Recruitment of subjects for the study
To recruit patients for the interviews, the investigators will screen all of the patients who present for endoscopic ultrasound (with biopsy) to the endoscopy unit or pre-procedure clinic at Loma Linda, as well as patients referred to the medical or surgical oncology clinics with a new diagnosis of pancreatic adenocarcinoma. The investigators will recruit patients from our gastroenterology clinic and endoscopic unit and the oncology clinic (the researcher's patients) both in person and over the phone via a telephone call. The investigators will not contact patients outside our clinical practice but will distribute an IRB-approved flyer with our number to oncology clinics that patients can call and leave a voicemail or email us at our secure HIPPA-complaint Loma Linda email address assigned to our study (cancerresearch@llu.edu). The investigators will also distribute an IRB-approved letter to other oncologists informing them of the study so they can distribute the flyer to their patients and inform patients who may be candidates for this study. The reason the investigators are including patients with suspected PDAC is to eliminate delays once they receive a diagnosis as patients previously reported a flurry of medical visits in the 2 weeks after diagnosis. However, patients will need to undergo a biopsy and have pathology confirmation before study initiation. Patients found to have other pathology on biopsy than pancreatic adenocarcinoma will be excluded. The investigators will explain the study inperson or over the phone when they are referred for a pancreatic biopsy or for oncologic care for a new diagnosis of pancreatic cancer. The investigators will explain that the investigators are recruiting them because they have pancreatic cancer and want to study if a community health worker can help patients like themselves navigate care and engage with palliative care better than the current care that patients receive. If they are interested, they will then be consented using written informed consent at their clinic visit in the clinic or prior to their in-person study visit.
When a patient is diagnosed with PDAC, they receive the diagnosis over the phone and follow-up in clinic. They are referred to medical and surgical oncology and to palliative care for supportive care..
- Conditions
- Pancreatic Cancer, Adult
- Being tested
- PAL-CHW-PDAC, Usual Care with Attention Control
- Keywords
- community health worker, pancreatic cancer, palliative care
- Medical subject headings
- Pancreatic cancer, adult, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAL-CHW-PDACBehavioural
The intervention involves meeting with a community health worker who will address quality of life concerns, including physical, spiritual, social, and psychological concerns, help patients schedule visits, and set them up to receive telehealth. They also monitor their symptoms via weekly text messages and receive help managing them. Finally, they help patients complete advanced care planning.
Usual Care with Attention ControlOther
This involves usual care at our institution, including referrals to medical oncology, surgical oncology, and palliative care but they also receive attention from the study coordinator completing 3 visits including survey instruments and are provided standard of care written and media-based materials from PANCAN and the National Pancreas Foundation.
| Study group | Role | What they receive |
|---|---|---|
| Community Health Worker Intervention | Experimental | They work with the community health worker to monitor symptoms and escalate palliative care visits as needed, receive care navigation and disease education Receives: Behavioral: PAL-CHW-PDAC |
| Attention Control with Usual Care | Active comparator | They receive usual care at our institution, including a referral to palliative care at diagnosis, referrals to oncology and medical oncology, and also the handouts from PANCAN provided in clinic, and access to videos from the National Pancreas Foundation. Receives: Other: Usual Care with Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index
This score goes from 0 to 72 with higher scores being better. It measures the symptom burden in pateints with pancreatic, biliary and liver cancers.
Measured: 12 weeks
Secondary outcomes (6)
Functional Assessment of Cancer Therapy Hepatobiliary
The FACT-Hep score measures quality of life in patients with pancreatic, biliary and liver cancers. The total score ranges from 0 to 180, with higher scores indicating better quality of life.
Measured: 12 weeks
Preparedness for Caregiving Scale
The score ranges from 0 to 5 and represents the mean of 8 questions. A higher score is better. It is designed to capture caregiver preparedness.
Measured: 12 weeks
City of Hope Caregiver QoL Instrument
This instrument score represents a mean of subscores and ranges from 0 to 10 with a higher score indicating better caregiver QoL
Measured: 12 weeks
Goal Concordant Care
This outcome will not be determined quantitatively but rather qualitatively by conducting interviews with the patient and caregiver (only the caregiver if the patient dies prior to 12 weeks). Thematic analyses will be peformed with the goal of identifying if the patient and caregiver feel that the care they received reflected their treatment goals.
Measured: 12 weeks
National Comprehensive Cancer Network Distress Thermometer for Patients
This measures psychological distress in pateints and scores from 0 to 10, with a lower score being better, i.e., representing lower levels of psychological distress.
Measured: 12 weeks
National Comprehensive Cancer Center Distress Thermometer for Caregivers
This measures psychological distress in caregivers and yields scores from 0 to 10, with lower scores indicating lower levels of psychological distress.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Sep 2025
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Cancer, AdultStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Nikhil Thiruvengadam, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591571
- Sponsor's protocol ID
- 5250314
- Other IDs
- PA230343
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the sensitive nature of personal health information and cancer, the investigators will not share patient data with other researchers.
Publications
Thiruvengadam NR, Kouanda A, Kalluri A, Schaubel D, Saumoy M, Forde K, Song J, Faggen A, Davis BG, Onwugaje KC, Cote G, Arain MA, Kochman ML. A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-reported Outcome Measure to Detect Post-ERCP Morbidity. Clin Gastroenterol Hepatol. 2023 May;21(5):1233-1242.e14. doi: 10.1016/j.cgh.2022.08.034. Epub 2022 Sep 6.
PubMed 36075501Chung V, Sun V, Ruel N, Smith TJ, Ferrell BR. Improving Palliative Care and Quality of Life in Pancreatic Cancer Patients. J Palliat Med. 2022 May;25(5):720-727. doi: 10.1089/jpm.2021.0187. Epub 2021 Oct 26.
PubMed 34704841
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Preliminary Efficacy of Our Digitally Enhanced CHW-led Intervention in Newly Diagnosed PDAC With a Pilot Randomized Controlled Trial of 60 PDAC Patients and Their Caregivers Comparing the Intervention to Attention Control With Usual Care.
- ClinicalTrials.gov ID
- NCT07591571
- Acronym / sponsor ID
- 5250314
- Conditions
- Pancreatic Cancer, Adult
- Keywords
- community health worker, pancreatic cancer, palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 15 May 2026 (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 goal of this clinical trial is to learn if a community health worker led intervention that helps facilitate palliative care works to treat newly-diagnostic pancreatic cancer. It will also help understand the impact of this intervention on people who are caregivers for patients with pancreatic cancer. The main questions it aims to answer are:
Does the community health worker improve symptoms and quality of life in patients with pancreatic cancer? Does the community health worker improve the burden of caregiving and quality of life in family caregivers? Researchers will compare drug ABC to a control (where patients get the care that patients with pancreatic cancer receive including access to handouts and videos that the investigators provide patients by national organizations) to see if the intervention works to help patients with pancreatic cancer.
Participants will:
Meet with study staff several times over 3 months and complete surveys about their experience and symptoms Patients assigned with the community health worker will meet with them in person or video.
Detailed description
- Overall study design
This will be a pilot randomized controlled trial where the investigators will plan on randomizing patients with PDAC in a 1:1 fashion to receive a digitally-enhanced community health worker intervention that will involve visits with the CHW and digital communication to facilitate care navigation and provide early palliative care engagement or usual care.
- Study Procedures and Schedule
Recruitment of subjects for the study
To recruit patients for the interviews, the investigators will screen all of the patients who present for endoscopic ultrasound (with biopsy) to the endoscopy unit or pre-procedure clinic at Loma Linda, as well as patients referred to the medical or surgical oncology clinics with a new diagnosis of pancreatic adenocarcinoma. The investigators will recruit patients from our gastroenterology clinic and endoscopic unit and the oncology clinic (the researcher's patients) both in person and over the phone via a telephone call. The investigators will not contact patients outside our clinical practice but will distribute an IRB-approved flyer with our number to oncology clinics that patients can call and leave a voicemail or email us at our secure HIPPA-complaint Loma Linda email address assigned to our study (cancerresearch@llu.edu). The investigators will also distribute an IRB-approved letter to other oncologists informing them of the study so they can distribute the flyer to their patients and inform patients who may be candidates for this study. The reason the investigators are including patients with suspected PDAC is to eliminate delays once they receive a diagnosis as patients previously reported a flurry of medical visits in the 2 weeks after diagnosis. However, patients will need to undergo a biopsy and have pathology confirmation before study initiation. Patients found to have other pathology on biopsy than pancreatic adenocarcinoma will be excluded. The investigators will explain the study inperson or over the phone when they are referred for a pancreatic biopsy or for oncologic care for a new diagnosis of pancreatic cancer. The investigators will explain that the investigators are recruiting them because they have pancreatic cancer and want to study if a community health worker can help patients like themselves navigate care and engage with palliative care better than the current care that patients receive. If they are interested, they will then be consented using written informed consent at their clinic visit in the clinic or prior to their in-person study visit.
When a patient is diagnosed with PDAC, they receive the diagnosis over the phone and follow-up in clinic. They are referred to medical and surgical oncology and to palliative care for supportive care..
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker Intervention | Experimental | Behavioral: PAL-CHW-PDACThey work with the community health worker to monitor symptoms and escalate palliative care visits as needed, receive care navigation and disease education |
| Attention Control with Usual Care | Active comparator | Other: Usual Care with Attention ControlThey receive usual care at our institution, including a referral to palliative care at diagnosis, referrals to oncology and medical oncology, and also the handouts from PANCAN provided in clinic, and access to videos from the National Pancreas Foundation. |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 90
- English or Spanish-Speaking
- Diagnosed with Newly-Diagnosed Pancreatic Adenocarcinoma or has a pancreatic mass on CT/MRI with suspected PDAC and is awaiting biopsy.
- Able to communicate verbally to allow for audio recording to complete an exit interview
- Must be able to consent
Key exclusion criteria (1 listed)
- Biopsy Does not Confirm Adenocarcinoma of the Pancreas
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 |
|---|---|---|
| PAL-CHW-PDACThe intervention involves meeting with a community health worker who will address quality of life concerns, including physical, spiritual, social, and psychological concerns, help patients schedule visits, and set them up to receive telehealth. They also monitor their symptoms via weekly text messages and receive help managing them. Finally, they help patients complete advanced care planning. | Behavioural | Community Health Worker Intervention |
| Usual Care with Attention ControlThis involves usual care at our institution, including referrals to medical oncology, surgical oncology, and palliative care but they also receive attention from the study coordinator completing 3 visits including survey instruments and are provided standard of care written and media-based materials from PANCAN and the National Pancreas Foundation. | Other | Attention Control with Usual Care |
Primary outcome
National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index
Time frame: 12 weeks
This score goes from 0 to 72 with higher scores being better. It measures the symptom burden in pateints with pancreatic, biliary and liver cancers.
6 secondary outcomes
Functional Assessment of Cancer Therapy Hepatobiliary
Time frame: 12 weeks
Preparedness for Caregiving Scale
Time frame: 12 weeks
City of Hope Caregiver QoL Instrument
Time frame: 12 weeks
Goal Concordant Care
Time frame: 12 weeks
National Comprehensive Cancer Network Distress Thermometer for Patients
Time frame: 12 weeks
National Comprehensive Cancer Center Distress Thermometer for Caregivers
Time frame: 12 weeks
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 Oct 2026.
- Background: PubMed 36075501Thiruvengadam NR, Kouanda A, Kalluri A, Schaubel D, Saumoy M, Forde K, Song J, Faggen A, Davis BG, Onwugaje KC, Cote G, Arain MA, Kochman ML. A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-reported Outcome Measure to Detect Post-ERCP Morbidity. Clin Gastroenterol Hepatol. 2023 May;21(5):1233-1242.e14. doi: 10.1016/j.cgh.2022.08.034. Epub 2022 Sep 6.
- Background: PubMed 34704841Chung V, Sun V, Ruel N, Smith TJ, Ferrell BR. Improving Palliative Care and Quality of Life in Pancreatic Cancer Patients. J Palliat Med. 2022 May;25(5):720-727. doi: 10.1089/jpm.2021.0187. Epub 2021 Oct 26.
- Individual participant dataSharing planned: No. Due to the sensitive nature of personal health information and cancer, the investigators will not share patient data with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAL-CHW-PDAC in people with Pancreatic Cancer, Adult, run by Loma Linda University 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 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: finished, as of the sponsor's last update on 30 Oct 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?
National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index (time frame: 12 weeks). 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 NCT07591571, which also lists 2 linked publications.
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 Oct 2026.