Telehealth Self-Management Coaching Sessions to Improve Quality of Life in Pancreatic Cancer Survivors and Their Family Care Givers
NCT Number: NCT06524973
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metastatic Pancreatic Adenocarcinoma
Interventions: OTHER: Telemedicine|OTHER: Counseling|OTHER: Best Practice|OTHER: Questionnaire Administration|OTHER: Inrweview
Sponsor: City of Hope Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 136
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-30
Completion Date: 2027-07-20
Locations: City of Hope at Arcadia, Arcadia, California, 91007, United States|City of Hope Corona, Corona, California, 92879, United States|City of Hope Comprehensive Cancer Center, Duarte, California, 91010, United States|City of Hope at Glendale, Glendale, California, 91204, United States|City of Hope at Glendora, Glendora, California, 91741, United States|City of Hope Seacliff, Huntington Beach, California, 92648, United States|City of Hope at Irvine Lennar, Irvine, California, 92618, United States|City of Hope at Irvine Sand Canyon, Irvine, California, 92618, United States|City of Hope Antelope Valley, Lancaster, California, 93534, United States|City of Hope at Long Beach Worsham, Long Beach, California, 90808, United States|City of Hope at Long Beach Elm, Long Beach, California, 90813, United States|City of Hope Mission Hills, Mission Hills, California, 91345, United States|City of Hope at Newport Beach Fashion Island, Newport Beach, California, 92660, United States|City of Hope at Palmdale, Palmdale, California, 93551, United States|City of Hope - Santa Clarita, Santa Clarita, California, 91355, United States|City of Hope at Simi Valley, Simi Valley, California, 93065, United States|City of Hope South Pasadena, South Pasadena, California, 91030, United States|City of Hope at Thousand Oaks, Thousand Oaks, California, 91361, United States|City of Hope South Bay, Torrance, California, 90503, United States|City of Hope Upland, Upland, California, 91786, United States|City of Hope West Covina, West Covina, California, 91790, United States

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.

Primary Outcome Measures: 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., At baseline and at 3 months post randomization
Secondary Outcome Measures: 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., Up to 25 months|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., Up to 6 months|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., Up to 6 months|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., Up to 6 months|Patient reported symptom severity, Treatment group comparisons will be assessed via repeated measures linear regression models with adjustment for baseline value of the outcome including sex and age 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., At baseline and at 3 and 6 months post randomization|Patient reported psychological distress, Patient reported psychological distress will be measured using the National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT). Treatment group comparisons will be assessed via repeated measures linear regression models with adjustment for baseline value of the outcome including sex and age 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., At baseline and at 3 and 6 months post randomization|Family care giver (FCG) psychological distress, FCG reported psychological distress will be measured using the NCCN DT. Treatment group comparisons will be assessed via repeated measures linear regression models with adjustment for baseline value of the outcome including sex and age 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., At baseline and at 3 and 6 months post randomization|FCG caregiving burden, FCG caregiving burden will be measured using the Montgomery Borgatta Caregiver Burden Scale. Treatment group comparisons will be assessed via repeated measures linear regression models with adjustment for baseline value of the outcome including sex and age 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., At baseline and at 3 and 6 months post randomization|FCG QOL, FCG QOL will be measured using City of Hope Quality of Life-Family questionnaire. Treatment group comparisons will be assessed via repeated measures linear regression models with adjustment for baseline value of the outcome including sex and age 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., At baseline and at 3 and 6 months post randomization|Overall survival, From initiation of intervention to death from any cause, up to 6 months
Other Outcome Measures: Chemotherapy in last 14 days of life, At 3 and 6 months post randomization|Emergency room visits in the last days of life, At 3 and 6 months post randomization|Intensive care unit admissions in the last 30 days of life, At 3 and 6 months post randomization|Hospice care for less than 3 days before death, At 3 and 6 months post randomization