Trial Title:
Telehealth Self-Management Coaching Sessions to Improve Quality of Life in Pancreatic Cancer Survivors and Their Family Care Givers
NCT ID:
NCT06524973
Condition:
Metastatic Pancreatic Adenocarcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Telemedicine
Description:
Attend telehealth self-management coaching sessions
Arm group label:
Arm A (telehealth self-management coaching sessions)
Intervention type:
Other
Intervention name:
Counseling
Description:
Attend telehealth self-management coaching sessions
Arm group label:
Arm A (telehealth self-management coaching sessions)
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive standard of care
Arm group label:
Arm B (standard of care)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm A (telehealth self-management coaching sessions)
Arm group label:
Arm B (standard of care)
Intervention type:
Other
Intervention name:
Inrweview
Description:
Ancillary studies
Arm group label:
Arm A (telehealth self-management coaching sessions)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
City of Hope at Arcadia
Address:
City:
Arcadia
Zip:
91007
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope Corona
Address:
City:
Corona
Zip:
92879
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope at Duarte
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vincent Chung, MD
Facility:
Name:
City of Hope Comprehensive Cancer Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope at Glendale
Address:
City:
Glendale
Zip:
91204
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope at Glendora
Address:
City:
Glendora
Zip:
91741
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope Seacliff
Address:
City:
Huntington Beach
Zip:
92648
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope at Irvine Lennar
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope at Irvine Sand Canyon
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope Antelope Valley
Address:
City:
Lancaster
Zip:
93534
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope at Long Beach Worsham
Address:
City:
Long Beach
Zip:
90808
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope at Long Beach Elm
Address:
City:
Long Beach
Zip:
90813
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Email:
VChung@coh.org
Facility:
Name:
City of Hope Mission Hills
Address:
City:
Mission Hills
Zip:
91345
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope at Newport Beach Fashion Island
Address:
City:
Newport Beach
Zip:
92660
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope at Palmdale
Address:
City:
Palmdale
Zip:
93551
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope - Santa Clarita
Address:
City:
Santa Clarita
Zip:
91355
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
800-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope at Simi Valley
Address:
City:
Simi Valley
Zip:
93065
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope South Pasadena
Address:
City:
South Pasadena
Zip:
91030
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope at Thousand Oaks
Address:
City:
Thousand Oaks
Zip:
91361
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope South Bay
Address:
City:
Torrance
Zip:
90503
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope Upland
Address:
City:
Upland
Zip:
91786
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Facility:
Name:
City of Hope West Covina
Address:
City:
West Covina
Zip:
91790
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-359-8111
Email:
VChung@coh.org
Start date:
October 7, 2024
Completion date:
May 3, 2027
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06524973
