Telehealth Self-Management Coaching Sessions to Improve Quality of Life in Pancreatic Cancer Survivors and Their Family Care Givers

Impacting Quality of Life and Pancreatic Cancer Survivorship Through a Telehealth Intervention

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Pancreatic Adenocarcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Other: Telemedicine; Other: Counseling; Other: Inrweview

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org

Study Locations

• United States
  • California
    • Arcadia, California, United States, 91007
      • Not yet recruiting
      • City of Hope at Arcadia
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • Corona, California, United States, 92879
      • Not yet recruiting
      • City of Hope Corona
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • Duarte, California, United States, 91010
      • Not yet recruiting
      • City of Hope Comprehensive Cancer Center
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope at Duarte
      • Contact: Vincent Chung, MD
    • Glendale, California, United States, 91204
      • Not yet recruiting
      • City of Hope at Glendale
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • Glendora, California, United States, 91741
      • Not yet recruiting
      • City of Hope at Glendora
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • Huntington Beach, California, United States, 92648
      • Not yet recruiting
      • City of Hope Seacliff
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • Irvine, California, United States, 92618
      • Not yet recruiting
      • City of Hope at Irvine Lennar
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • Irvine, California, United States, 92618
      • Not yet recruiting
      • City of Hope at Irvine Sand Canyon
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • Lancaster, California, United States, 93534
      • Not yet recruiting
      • City of Hope Antelope Valley
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • Long Beach, California, United States, 90808
      • Not yet recruiting
      • City of Hope at Long Beach Worsham
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • Long Beach, California, United States, 90813
      • Not yet recruiting
      • City of Hope at Long Beach Elm
      • Contact: Vincent Chung, MD; Email: VChung@coh.org
    • Mission Hills, California, United States, 91345
      • Not yet recruiting
      • City of Hope Mission Hills
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • Newport Beach, California, United States, 92660
      • Not yet recruiting
      • City of Hope at Newport Beach Fashion Island
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • Palmdale, California, United States, 93551
      • Not yet recruiting
      • City of Hope at Palmdale
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • Santa Clarita, California, United States, 91355
      • Not yet recruiting
      • City of Hope - Santa Clarita
      • Contact: Vincent Chung, MD; Phone Number: 800-359-8111; Email: VChung@coh.org
    • Simi Valley, California, United States, 93065
      • Not yet recruiting
      • City of Hope at Simi Valley
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • South Pasadena, California, United States, 91030
      • Not yet recruiting
      • City of Hope South Pasadena
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • Thousand Oaks, California, United States, 91361
      • Not yet recruiting
      • City of Hope at Thousand Oaks
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • Torrance, California, United States, 90503
      • Not yet recruiting
      • City of Hope South Bay
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • Upland, California, United States, 91786
      • Not yet recruiting
      • City of Hope Upland
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org
    • West Covina, California, United States, 91790
      • Not yet recruiting
      • City of Hope West Covina
      • Contact: Vincent Chung, MD; Phone Number: 626-359-8111; Email: vchung@coh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Questionnaire Administration; Ancillary studies; Other: Telemedicine; Attend telehealth self-management coaching sessions; Other: Counseling; Attend telehealth self-management coaching sessions; Other: Inrweview; Ancillary studies
Active Comparator: Arm B (standard of care); Patients and FCGs receive standard of care on study.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported quality of life (QOL)	Patient reported quality of life will be assessed by the Functional Assessment of Cancer Therapy- Hepatobiliary (FACT-Hep) quality of life score. The primary analysis will be a treatment group comparison of the QOL at 3 months via linear regression model, with adjustment for baseline FACT-Hep score and stratification factors. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.	At baseline and at 3 months post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate	Feasibility of the intervention will be defined as at least 60% of eligible participants enrolling. Descriptive statistics will be used to summarize the feasibility of the intervention. Reasons for non-participation will be recorded and used to make needed modifications for improvement in future studies.	Up to 25 months
Intervention completion rate	Feasibility of the intervention will be defined as at least 60% of participants completing ≥ 80% of the intervention (4 of 6 sessions). Descriptive statistics will be used to summarize the feasibility of the intervention. Reasons for attrition will be recorded and used to make needed modifications for improvement in future studies.	Up to 6 months
Rate of participants completing any follow-up assessments	Feasibility of the intervention will be defined as at least 60% of participants completing any follow-up assessments after randomization. Descriptive statistics will be used to summarize the feasibility of the intervention. Reasons for attrition will be recorded and used to make needed modifications for improvement in future studies.	Up to 6 months
Participant experience	Participant experiences with the intervention will be explored through qualitative data (structured exit interviews) from participants randomized to the intervention group and analyzed using content analysis approach. Interviews will be transcribed and data analyzed. Transcripts will be imported for the development of analytic categories, data coding, and review of coded data. Codes will be sorted into themes based on links and relationship.	Up to 6 months
Patient reported symptom severity	Treatment group comparisons will be assessed via repeated measures linear regression models with adjustment for baseline value of the outcome including sex and age and stratification factors. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.	At baseline and at 3 and 6 months post randomization
Patient reported psychological distress	Patient reported psychological distress will be measured using the National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT). Treatment group comparisons will be assessed via repeated measures linear regression models with adjustment for baseline value of the outcome including sex and age and stratification factors. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.	At baseline and at 3 and 6 months post randomization
Family care giver (FCG) psychological distress	FCG reported psychological distress will be measured using the NCCN DT. Treatment group comparisons will be assessed via repeated measures linear regression models with adjustment for baseline value of the outcome including sex and age and stratification factors. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.	At baseline and at 3 and 6 months post randomization
FCG caregiving burden	FCG caregiving burden will be measured using the Montgomery Borgatta Caregiver Burden Scale. Treatment group comparisons will be assessed via repeated measures linear regression models with adjustment for baseline value of the outcome including sex and age and stratification factors. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.	At baseline and at 3 and 6 months post randomization
FCG QOL	FCG QOL will be measured using City of Hope Quality of Life-Family questionnaire. Treatment group comparisons will be assessed via repeated measures linear regression models with adjustment for baseline value of the outcome including sex and age and stratification factors. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.	At baseline and at 3 and 6 months post randomization
Overall survival		From initiation of intervention to death from any cause, up to 6 months

Other Outcome Measures

Outcome Measure	Time Frame
Chemotherapy in last 14 days of life	At 3 and 6 months post randomization
Emergency room visits in the last days of life	At 3 and 6 months post randomization
Intensive care unit admissions in the last 30 days of life	At 3 and 6 months post randomization
Hospice care for less than 3 days before death	At 3 and 6 months post randomization

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Investigators: Principal Investigator: Vincent Chung, MD, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Estimated): May 3, 2027
• Study Completion (Estimated): May 3, 2027

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 6, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Health Services Administration; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Quality of Health Care; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Mental Health Services; Guidelines as Topic; Quality Assurance, Health Care; Patient Care Management; Practice Guidelines as Topic; Telemedicine; Counseling
• Other Study ID Numbers: 24172 (Health Institutes of Türkiye (TUSEB)); NCI-2024-06078 (Other Identifier: P30)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: not yet decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No