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Telehealth Self-Management Coaching Sessions to Improve Quality of Life in Pancreatic Cancer Survivors and Their Family Care Givers
Trial Status: active
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.
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 be within 8 weeks of beginning treatments for pancreatic adenocarcinoma
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
Additional locations may be listed on ClinicalTrials.gov for NCT06524973.
I. Compare patient-reported quality of life (QOL) at 3 months post-randomization.
SECONDARY OBJECTIVES:
I. Assess the feasibility of the intervention.
II. Compare survivor symptom severity, survivor/FCG psychological distress, FCG burden, FCG QOL, palliative care quality metrics (chemotherapy in the last 14 days of life, emergency room [ER] visits in the last days of life, intensive care unit [ICU] admissions in the last 30 days of life, hospice care for less than 3 days before death) at 3 and 6 months.
III. Compare overall survival.
OUTLINE: Patients and their FCGs are randomized to 1 of 2 arms.
ARM A: Patients and FCGs attend telehealth self-management coaching sessions over 40-60 minutes every other week for 6 sessions over 3 months.
ARM B: Patients and FCGs receive standard of care on study.
After completion of study intervention, participants are followed up at 6 months.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationCity of Hope Comprehensive Cancer Center
