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

City of Hope

Status: Enrolling

Conditions: Metastatic Pancreatic Adenocarcinoma

Treatments: Other: Best Practice; Other: Telemedicine; Other: Inrweview; Other: Questionnaire Administration; Other: Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT06524973

24172

NCI-2024-06078 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Arm A (telehealth self-management coaching sessions)

Experimental group

Description:

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

Treatment:

Other: Counseling

Other: Questionnaire Administration

Other: Inrweview

Other: Telemedicine

Arm B (standard of care)

Active Comparator group

Description:

Patients and FCGs receive standard of care on study.

Treatment:

Other: Questionnaire Administration

Other: Best Practice