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.
• 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
• 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
Parallel
Telemedicine
Other interventionAttend telehealth self-management coaching sessions
Counseling
Other interventionAttend telehealth self-management coaching sessions
Best Practice
Other interventionReceive standard of care
Questionnaire Administration
Other interventionAncillary studies
Inrweview
Other interventionAncillary studies
Patient reported quality of life (QOL)
Patient reported quality of life will be assessed by the Functional Assessment of Cancer Therapy- Hepatobiliary (FACT-Hep) quality of life score. The primary analysis will be a treatment group comparison of the QOL at 3 months via linear regression model, with adjustment for baseline FACT-Hep score and stratification factors. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Enrollment rate
Feasibility of the intervention will be defined as at least 60% of eligible participants enrolling. Descriptive statistics will be used to summarize the feasibility of the intervention. Reasons for non-participation will be recorded and used to make needed modifications for improvement in future studies.
Intervention completion rate
Feasibility of the intervention will be defined as at least 60% of participants completing ≥ 80% of the intervention (4 of 6 sessions). Descriptive statistics will be used to summarize the feasibility of the intervention. Reasons for attrition will be recorded and used to make needed modifications for improvement in future studies.
Rate of participants completing any follow-up assessments
Feasibility of the intervention will be defined as at least 60% of participants completing any follow-up assessments after randomization. Descriptive statistics will be used to summarize the feasibility of the intervention. Reasons for attrition will be recorded and used to make needed modifications for improvement in future studies.
Participant experience
Participant experiences with the intervention will be explored through qualitative data (structured exit interviews) from participants randomized to the intervention group and analyzed using content analysis approach. Interviews will be transcribed and data analyzed. Transcripts will be imported for the development of analytic categories, data coding, and review of coded data. Codes will be sorted into themes based on links and relationship.
Chemotherapy in last 14 days of life
Emergency room visits in the last days of life
Intensive care unit admissions in the last 30 days of life
Hospice care for less than 3 days before death
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City of Hope Medical Center
Lead sponsor
United States Department of Defense
Collaborator
