Recruiting

Observational Study

Sponsor:

City of Hope Medical Center

Code:

NCT06524973

Conditions

Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Telemedicine

Counseling

Best Practice

Questionnaire Administration

Inrweview

Study Details

Brief summary:

This clinical trial evaluates the impact of telehealth self-management coaching sessions on quality of life in pancreatic cancer survivors and their family care givers (FCGs). Patients with pancreatic cancer experience many symptoms because of the disease and treatment, which can have a negative impact on quality of life. Patients and their families have unmet needs during treatment, including a lack of quality of life programs that offer support to patients. Supporting patients and families on managing the physical symptoms, emotional well-being, social well-being and spiritual well-being with telehealth self-management coaching sessions may help improve quality of life, manage symptoms from treatment, and support families in their role as caregivers during treatment.

Conditions

Metastatic Pancreatic Adenocarcinoma

Study ID

NCT06524973

Start date

Oct 7, 2024

Status verified date

Nov, 2025

Completion date

May 3, 2027

Anticipated

Primary completion date

May 3, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • • PATIENT: Documented informed consent of the participant and/or legally authorized representative

  • Assent, when appropriate, will be obtained per institutional guidelines

  • PATIENT: Age: ≥ 18 years
  • PATIENT: Eastern Cooperative Oncology Group (ECOG) ≤ 2
  • PATIENT: Ability to read and understand English or Spanish for questionnaires
  • PATIENT: Subjects must have histologically or cytologically confirmed diagnosis of metastatic pancreatic adenocarcinoma who are within 8 weeks of initial diagnosis
  • FAMILY CARE GIVER: Documented informed consent of the participant and/or legally authorized representative
  • Assent, when appropriate, will be obtained per institutional guidelines

  • FAMILY CARE GIVER: Age: ≥ 18 years
  • FAMILY CARE GIVER: Ability to read and understand English or Spanish for questionnaires
  • FAMILY CARE GIVER: A family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care

Exclusion Criteria:

  • • An employee who is under the direct/ indirect supervision of the principal investigator (PI)/ a co-investigator/ the study manager

  • A direct study team member

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm A (telehealth self-management coaching sessions)

Patients and FCGs attend telehealth self-management coaching sessions over 40-60 minutes every other week for 6 sessions over 3 months.

active comparator: Arm B (standard of care)

Patients and FCGs receive standard of care on study.

Interventions

Telemedicine

Attend telehealth self-management coaching sessions

Counseling

Attend telehealth self-management coaching sessions

Best Practice

Receive standard of care

Questionnaire Administration

Ancillary studies

Inrweview

Ancillary studies

Primary outcome measure

  • Patient reported quality of life (QOL) [ Time Frame: At baseline and at 3 months post randomization ]

Central Contacts and Locations

Central contacts

Vincent Chung, MD

626-359-8111vchung@coh.org

Locations

City of Hope at Duarte

Recruiting

Duarte, California, United States, 91010

More Information

Sponsor

City of Hope Medical Center

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2025-11-10.