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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-07

Study Completion Date

2027-05-03

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Pancreatic Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Telemedicine

Intervention Type OTHER

Attend telehealth self-management coaching sessions

Counseling

Intervention Type OTHER

Attend telehealth self-management coaching sessions

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Inrweview

Intervention Type OTHER

Ancillary studies

Arm B (standard of care)

Patients and FCGs receive standard of care on study.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive standard of care

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Telemedicine

Attend telehealth self-management coaching sessions

Intervention Type OTHER

Counseling

Attend telehealth self-management coaching sessions

Intervention Type OTHER

Best Practice

Receive standard of care

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Inrweview

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent Chung, MD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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