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

November 6, 2025 updated by: City of Hope Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:
      • Corona, California, United States, 92879
        • Not yet recruiting
        • City of Hope Corona
        • Contact:
      • Duarte, California, United States, 91010
        • Not yet recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
      • 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:
      • Glendora, California, United States, 91741
        • Not yet recruiting
        • City of Hope at Glendora
        • Contact:
      • Huntington Beach, California, United States, 92648
        • Not yet recruiting
        • City of Hope Seacliff
        • Contact:
      • Irvine, California, United States, 92618
        • Not yet recruiting
        • City of Hope at Irvine Lennar
        • Contact:
      • Irvine, California, United States, 92618
        • Not yet recruiting
        • City of Hope at Irvine Sand Canyon
        • Contact:
      • Lancaster, California, United States, 93534
        • Not yet recruiting
        • City of Hope Antelope Valley
        • Contact:
      • Long Beach, California, United States, 90808
        • Not yet recruiting
        • City of Hope at Long Beach Worsham
        • Contact:
      • Long Beach, California, United States, 90813
        • Not yet recruiting
        • City of Hope at Long Beach Elm
        • Contact:
      • Mission Hills, California, United States, 91345
        • Not yet recruiting
        • City of Hope Mission Hills
        • Contact:
      • Newport Beach, California, United States, 92660
        • Not yet recruiting
        • City of Hope at Newport Beach Fashion Island
        • Contact:
      • Palmdale, California, United States, 93551
        • Not yet recruiting
        • City of Hope at Palmdale
        • Contact:
      • Santa Clarita, California, United States, 91355
        • Not yet recruiting
        • City of Hope - Santa Clarita
        • Contact:
      • Simi Valley, California, United States, 93065
        • Not yet recruiting
        • City of Hope at Simi Valley
        • Contact:
      • South Pasadena, California, United States, 91030
        • Not yet recruiting
        • City of Hope South Pasadena
        • Contact:
      • Thousand Oaks, California, United States, 91361
        • Not yet recruiting
        • City of Hope at Thousand Oaks
        • Contact:
      • Torrance, California, United States, 90503
        • Not yet recruiting
        • City of Hope South Bay
        • Contact:
      • Upland, California, United States, 91786
        • Not yet recruiting
        • City of Hope Upland
        • Contact:
      • West Covina, California, United States, 91790
        • Not yet recruiting
        • City of Hope West Covina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient reported quality of life (QOL)
Time Frame: At baseline and at 3 months post randomization
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Enrollment rate
Time Frame: Up to 25 months
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
Time Frame: Up to 6 months
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
Time Frame: Up to 6 months
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
Time Frame: Up to 6 months
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
Time Frame: At baseline and at 3 and 6 months post randomization
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
Time Frame: At baseline and at 3 and 6 months post randomization
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
Time Frame: At baseline and at 3 and 6 months post randomization
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
Time Frame: At baseline and at 3 and 6 months post randomization
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
Time Frame: At baseline and at 3 and 6 months post randomization
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
Time Frame: From initiation of intervention to death from any cause, up to 6 months
From initiation of intervention to death from any cause, up to 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Chemotherapy in last 14 days of life
Time Frame: At 3 and 6 months post randomization
At 3 and 6 months post randomization
Emergency room visits in the last days of life
Time Frame: At 3 and 6 months post randomization
At 3 and 6 months post randomization
Intensive care unit admissions in the last 30 days of life
Time Frame: At 3 and 6 months post randomization
At 3 and 6 months post randomization
Hospice care for less than 3 days before death
Time Frame: At 3 and 6 months post randomization
At 3 and 6 months post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
City of Hope Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vincent Chung, MD, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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