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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-06078 | Other Identifier | P30 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (telehealth self-management coaching sessions) | Experimental | Patients and FCGs attend telehealth self-management coaching sessions over 40-60 minutes every other week for 6 sessions over 3 months. |
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| Arm B (standard of care) | Active Comparator | Patients and FCGs receive standard of care on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine | Other | Attend telehealth self-management coaching sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
• PATIENT: Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
Assent, when appropriate, will be obtained per institutional guidelines
Exclusion Criteria:
• An employee who is under the direct/ indirect supervision of the principal investigator (PI)/ a co-investigator/ the study manager
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent Chung, MD | Contact | 626-359-8111 | vchung@coh.org |
| Name | Affiliation | Role |
|---|---|---|
| Vincent Chung, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope at Arcadia | Not yet recruiting | Arcadia | California | 91007 | United States |
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| Counseling | Other | Attend telehealth self-management coaching sessions |
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| Best Practice | Other | Receive standard of care |
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| Questionnaire Administration | Other | Ancillary studies |
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| Inrweview | Other | Ancillary studies |
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| 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 |
| At 3 and 6 months post randomization |
| Hospice care for less than 3 days before death | At 3 and 6 months post randomization |
| City of Hope Corona | Not yet recruiting | Corona | California | 92879 | United States |
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| City of Hope at Duarte | Recruiting | Duarte | California | 91010 | United States |
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| City of Hope Comprehensive Cancer Center | Not yet recruiting | Duarte | California | 91010 | United States |
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| City of Hope at Glendale | Not yet recruiting | Glendale | California | 91204 | United States |
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| City of Hope at Glendora | Not yet recruiting | Glendora | California | 91741 | United States |
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| City of Hope Seacliff | Not yet recruiting | Huntington Beach | California | 92648 | United States |
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| City of Hope at Irvine Lennar | Not yet recruiting | Irvine | California | 92618 | United States |
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| City of Hope at Irvine Sand Canyon | Not yet recruiting | Irvine | California | 92618 | United States |
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| City of Hope Antelope Valley | Not yet recruiting | Lancaster | California | 93534 | United States |
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| City of Hope at Long Beach Worsham | Not yet recruiting | Long Beach | California | 90808 | United States |
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| City of Hope at Long Beach Elm | Not yet recruiting | Long Beach | California | 90813 | United States |
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| City of Hope Mission Hills | Not yet recruiting | Mission Hills | California | 91345 | United States |
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| City of Hope at Newport Beach Fashion Island | Not yet recruiting | Newport Beach | California | 92660 | United States |
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| City of Hope at Palmdale | Not yet recruiting | Palmdale | California | 93551 | United States |
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| City of Hope - Santa Clarita | Not yet recruiting | Santa Clarita | California | 91355 | United States |
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| City of Hope at Simi Valley | Not yet recruiting | Simi Valley | California | 93065 | United States |
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| City of Hope South Pasadena | Not yet recruiting | South Pasadena | California | 91030 | United States |
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| City of Hope at Thousand Oaks | Not yet recruiting | Thousand Oaks | California | 91361 | United States |
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| City of Hope South Bay | Not yet recruiting | Torrance | California | 90503 | United States |
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| City of Hope Upland | Not yet recruiting | Upland | California | 91786 | United States |
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| City of Hope West Covina | Not yet recruiting | West Covina | California | 91790 | United States |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D003376 | Counseling |
| D017410 | Practice Guidelines as Topic |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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