To Evaluate the Preliminary Efficacy of Our Digitally Enhanced CHW-led Intervention in Newly Diagnosed PDAC

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLoma Linda University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • PAL-CHW-PDAC

    Behavioral

    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 Control

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Community Health Worker InterventionExperimental treatment 1 intervention
Group B: Attention Control with Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks

Secondary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks
3

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

Time frame
12 weeks
4

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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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