Telehealth Self-Management Coaching Sessions To Improve Quality Of Life In Pancreatic Cancer Survivors And Their Family Care Givers

Study Overview

Telehealth Self-Management Coaching Sessions to Improve Quality of Life in Pancreatic Cancer Survivors and Their Family Care Givers

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.

N/A

Metastatic Pancreatic Adenocarcinoma

OTHER: Telemedicine
OTHER: Counseling
OTHER: Best Practice
OTHER: Questionnaire Administration
OTHER: Inrweview

24172
NCI-2024-06078 (OTHER Identifier) (OTHER: P30)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-07-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-11-05
First Submitted that Met QC Criteria 2024-07-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-11-06
First Posted (ACTUAL) 2024-07-29	Results First Posted N/A	Last Verified 2024-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm A (telehealth self-management coaching sessions) Patients and FCGs attend telehealth self-management coaching sessions over 40-60 minutes every other week for 6 sessions over 3 months.	OTHER: Telemedicine Attend telehealth self-management coaching sessions OTHER: Counseling Attend telehealth self-management coaching sessions OTHER: Questionnaire Administration Ancillary studies OTHER: Inrweview Ancillary studies
ACTIVE_COMPARATOR: Arm B (standard of care) Patients and FCGs receive standard of care on study.	OTHER: Best Practice Receive standard of care OTHER: Questionnaire Administration Ancillary studies

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm A (telehealth self-management coaching sessions)

Patients and FCGs attend telehealth self-management coaching sessions over 40-60 minutes every other week for 6 sessions over 3 months.

OTHER: Telemedicine

Attend telehealth self-management coaching sessions

OTHER: Counseling

Attend telehealth self-management coaching sessions

OTHER: Questionnaire Administration

Ancillary studies

OTHER: Inrweview

Ancillary studies

ACTIVE_COMPARATOR: Arm B (standard of care)

Patients and FCGs receive standard of care on study.

OTHER: Best Practice

Receive standard of care

OTHER: Questionnaire Administration

Ancillary studies

Primary Outcome Measures	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

Secondary Outcome Measures	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
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Vincent Chung, MD

Phone Number: 626-359-8111

Email: vchung@coh.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

• 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

• 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Vincent Chung, MD, City of Hope Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record