Metastatic Pancreatic Adenocarcinoma
Conditions
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.
Interventions
OTHERTelemedicine
Attend telehealth self-management coaching sessions
OTHERCounseling
Attend telehealth self-management coaching sessions
OTHERBest Practice
Receive standard of care
OTHERQuestionnaire Administration
Ancillary studies
OTHERInrweview
Ancillary studies
Sponsors
City of Hope Medical Center
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported quality of life (QOL) | At baseline and at 3 months post randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment rate | Up to 25 months | 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 | Up to 6 months | 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 | Up to 6 months | 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 | Up to 6 months | 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. |
| Patient reported symptom severity | At baseline and at 3 and 6 months post randomization | 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. |
| Patient reported psychological distress | At baseline and at 3 and 6 months post randomization | 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. |
| Family care giver (FCG) psychological distress | At baseline and at 3 and 6 months post randomization | 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. |
| FCG caregiving burden | At baseline and at 3 and 6 months post randomization | 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. |
| FCG QOL | At baseline and at 3 and 6 months post randomization | 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. |
| Overall survival | From initiation of intervention to death from any cause, up to 6 months | — |
Countries
United States
Contacts
CONTACTVincent Chung, MD
PRINCIPAL_INVESTIGATORVincent Chung, MD
City of Hope Medical Center
Outcome results
None listed