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

NCT06524973 | Recruiting DMC

• 2 other identifiers: 24172NCI-2024-06078
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 22

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Enrollment rate

  Up to 25 months

• Intervention completion rate

  Up to 6 months

• Rate of participants completing any follow-up assessments

  Up to 6 months

• Participant experience

  Up to 6 months

• Patient reported symptom severity

  At baseline and at 3 and 6 months post randomization

Other Outcomes (4)

• 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

Study Arms (2)

Arm A (telehealth self-management coaching sessions)

EXPERIMENTAL

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

Other: Telemedicine; Other: Counseling; Other: Questionnaire Administration; Other: Inrweview

Arm B (standard of care)

ACTIVE COMPARATOR

Patients and FCGs receive standard of care on study.

Other: Best Practice; Other: Questionnaire Administration

Interventions

Telemedicine OTHER

Attend telehealth self-management coaching sessions

Arm A (telehealth self-management coaching sessions)

Counseling OTHER

Attend telehealth self-management coaching sessions

Arm A (telehealth self-management coaching sessions)

Best Practice OTHER

Receive standard of care

Arm B (standard of care)

Questionnaire Administration OTHER

Ancillary studies

Arm A (telehealth self-management coaching sessions); Arm B (standard of care)

Inrweview OTHER

Ancillary studies

Arm A (telehealth self-management coaching sessions)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (22)

City of Hope at Arcadia

Arcadia, California, 91007, United States

NOT YET RECRUITING

City of Hope Corona

Corona, California, 92879, United States

NOT YET RECRUITING

City of Hope at Duarte

Duarte, California, 91010, United States

RECRUITING

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

NOT YET RECRUITING

City of Hope at Glendale

Glendale, California, 91204, United States

NOT YET RECRUITING

City of Hope at Glendora

Glendora, California, 91741, United States

NOT YET RECRUITING

City of Hope Seacliff

Huntington Beach, California, 92648, United States

NOT YET RECRUITING

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

NOT YET RECRUITING

City of Hope at Irvine Sand Canyon

Irvine, California, 92618, United States

NOT YET RECRUITING

City of Hope Antelope Valley

Lancaster, California, 93534, United States

NOT YET RECRUITING

City of Hope at Long Beach Worsham

Long Beach, California, 90808, United States

NOT YET RECRUITING

City of Hope at Long Beach Elm

Long Beach, California, 90813, United States

NOT YET RECRUITING

City of Hope Mission Hills

Mission Hills, California, 91345, United States

NOT YET RECRUITING

City of Hope at Newport Beach Fashion Island

Newport Beach, California, 92660, United States

NOT YET RECRUITING

City of Hope at Palmdale

Palmdale, California, 93551, United States

NOT YET RECRUITING

City of Hope - Santa Clarita

Santa Clarita, California, 91355, United States

NOT YET RECRUITING

City of Hope at Simi Valley

Simi Valley, California, 93065, United States

NOT YET RECRUITING

City of Hope South Pasadena

South Pasadena, California, 91030, United States

NOT YET RECRUITING

City of Hope at Thousand Oaks

Thousand Oaks, California, 91361, United States

NOT YET RECRUITING

City of Hope South Bay

Torrance, California, 90503, United States

NOT YET RECRUITING

City of Hope Upland

Upland, California, 91786, United States

NOT YET RECRUITING

City of Hope West Covina

West Covina, California, 91790, United States

NOT YET RECRUITING

MeSH Terms

Interventions

Telemedicine; Counseling; Practice Guidelines as Topic

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Vincent Chung, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Chung, MD

CONTACT

626-359-8111; vchung@coh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: October 7, 2024
• Primary Completion (Estimated): May 3, 2027
• Study Completion (Estimated): May 3, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (22)