Clinical trial NCT06524973: Telehealth Self-Management Coaching Sessions to Improve Quality of Life in Pancreatic Cancer Survivors and Their Family Care Givers
Official title: Impacting Quality of Life and Pancreatic Cancer Survivorship Through a Telehealth Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Pancreatic Adenocarcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient reported quality of life (QOL)
timeFrame: At baseline and at 3 months post randomization
Secondary outcomes:
measure: Enrollment rate
timeFrame: Up to 25 months
measure: Intervention completion rate
timeFrame: Up to 6 months
measure: Rate of participants completing any follow-up assessments
timeFrame: Up to 6 months
measure: Participant experience
timeFrame: Up to 6 months
measure: Patient reported symptom severity
timeFrame: At baseline and at 3 and 6 months post randomization
measure: Patient reported psychological distress
timeFrame: At baseline and at 3 and 6 months post randomization
measure: Family care giver (FCG) psychological distress
timeFrame: At baseline and at 3 and 6 months post randomization
measure: FCG caregiving burden
timeFrame: At baseline and at 3 and 6 months post randomization
measure: FCG QOL
timeFrame: At baseline and at 3 and 6 months post randomization
measure: Overall survival
timeFrame: From initiation of intervention to death from any cause, up to 6 months
Other outcomes:
measure: Chemotherapy in last 14 days of life
timeFrame: At 3 and 6 months post randomization
measure: Emergency room visits in the last days of life
timeFrame: At 3 and 6 months post randomization
measure: Intensive care unit admissions in the last 30 days of life
timeFrame: At 3 and 6 months post randomization
measure: Hospice care for less than 3 days before death
timeFrame: At 3 and 6 months post randomization
Locations:
city: Arcadia
country: United States
facility: City of Hope at Arcadia
state: California
city: Corona
country: United States
facility: City of Hope Corona
state: California
city: Duarte
country: United States
facility: City of Hope at Duarte
state: California
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Glendale
country: United States
facility: City of Hope at Glendale
state: California
city: Glendora
country: United States
facility: City of Hope at Glendora
state: California
city: Huntington Beach
country: United States
facility: City of Hope Seacliff
state: California
city: Irvine
country: United States
facility: City of Hope at Irvine Lennar
state: California
city: Irvine
country: United States
facility: City of Hope at Irvine Sand Canyon
state: California
city: Lancaster
country: United States
facility: City of Hope Antelope Valley
state: California
city: Long Beach
country: United States
facility: City of Hope at Long Beach Worsham
state: California
city: Long Beach
country: United States
facility: City of Hope at Long Beach Elm
state: California
city: Mission Hills
country: United States
facility: City of Hope Mission Hills
state: California
city: Newport Beach
country: United States
facility: City of Hope at Newport Beach Fashion Island
state: California
city: Palmdale
country: United States
facility: City of Hope at Palmdale
state: California
city: Santa Clarita
country: United States
facility: City of Hope - Santa Clarita
state: California
city: Simi Valley
country: United States
facility: City of Hope at Simi Valley
state: California
city: South Pasadena
country: United States
facility: City of Hope South Pasadena
state: California
city: Thousand Oaks
country: United States
facility: City of Hope at Thousand Oaks
state: California
city: Torrance
country: United States
facility: City of Hope South Bay
state: California
city: Upland
country: United States
facility: City of Hope Upland
state: California
city: West Covina
country: United States
facility: City of Hope West Covina
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Vincent Chung, MD
role: PRINCIPAL_INVESTIGATOR
References: