Metastatic Pancreatic AdenocarcinomaNCT06524973
Telehealth Self-Management Coaching Sessions to Improve Quality of Life in Pancreatic Cancer Survivors and Their Family Care Givers
A study testing Telemedicine, Counseling and Best Practice in people with Metastatic Pancreatic Adenocarcinoma, run by City of Hope Medical Center at 22 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- Telemedicine, Counseling and Best Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 22 sitesUnited States
- Study dates
- 7 Oct 2024to 3 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
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- 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
Who cannot join
- • 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
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
United States22 sites, 22 recruiting
- Not yet recruiting
City of Hope at Arcadia
Arcadia, California, 91007
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope Corona
Corona, California, 92879
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Recruiting
City of Hope at Duarte
Duarte, California, 91010
Vincent Chung, MD
- Not yet recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope at Glendale
Glendale, California, 91204
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope at Glendora
Glendora, California, 91741
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope Seacliff
Huntington Beach, California, 92648
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope at Irvine Lennar
Irvine, California, 92618
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope at Irvine Sand Canyon
Irvine, California, 92618
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope Antelope Valley
Lancaster, California, 93534
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope at Long Beach Worsham
Long Beach, California, 90808
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope at Long Beach Elm
Long Beach, California, 90813
Vincent Chung, MD, VChung@coh.org
- Not yet recruiting
City of Hope Mission Hills
Mission Hills, California, 91345
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope at Newport Beach Fashion Island
Newport Beach, California, 92660
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope at Palmdale
Palmdale, California, 93551
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope - Santa Clarita
Santa Clarita, California, 91355
Vincent Chung, MD, 800-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope at Simi Valley
Simi Valley, California, 93065
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope South Pasadena
South Pasadena, California, 91030
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope at Thousand Oaks
Thousand Oaks, California, 91361
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope South Bay
Torrance, California, 90503
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope Upland
Upland, California, 91786
Vincent Chung, MD, 626-359-8111, VChung@coh.org
- Not yet recruiting
City of Hope West Covina
West Covina, California, 91790
Vincent Chung, MD, 626-359-8111, VChung@coh.org
About this study
Official title: Impacting Quality of Life and Pancreatic Cancer Survivorship Through a Telehealth Intervention
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.
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Being tested
- Telemedicine, Counseling, Best Practice, Questionnaire Administration, Inrweview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Attend telehealth self-management coaching sessions
CounselingOther
Attend telehealth self-management coaching sessions
Best PracticeOther
Receive standard of care
Questionnaire AdministrationOther
Ancillary studies
InrweviewOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Telemedicine; Other: Counseling; Other: Questionnaire Administration; Other: Inrweview |
| Arm B (standard of care) | Active comparator | Patients and FCGs receive standard of care on study. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and at 3 months post randomization
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline and at 3 and 6 months post randomization
Overall survival
Measured: From initiation of intervention to death from any cause, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start7 Oct 2024
- Primary completion3 May 2027 (estimated)
- Study completion3 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Vincent Chung, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524973
- Sponsor's protocol ID
- 24172
- Other IDs
- NCI-2024-06078
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacting Quality of Life and Pancreatic Cancer Survivorship Through a Telehealth Intervention
- ClinicalTrials.gov ID
- NCT06524973
- Acronym / sponsor ID
- 24172
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 3 May 2027 (estimated)
- Study completion
- 3 May 2027 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (telehealth self-management coaching sessions) | Experimental | Other: Telemedicine, Other: Counseling, Other: Questionnaire Administration, Other: InrweviewPatients and FCGs attend telehealth self-management coaching sessions over 40-60 minutes every other week for 6 sessions over 3 months. |
| Arm B (standard of care) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationPatients and FCGs receive standard of care on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- • PATIENT: Documented informed consent of the participant and/or legally authorized representative
Key exclusion criteria (2 listed)
- • An employee who is under the direct/ indirect supervision of the principal investigator (PI)/ a co-investigator/ the study manager
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineAttend telehealth self-management coaching sessions | Other | Arm A (telehealth self-management coaching sessions) |
| CounselingAttend telehealth self-management coaching sessions | Other | Arm A (telehealth self-management coaching sessions) |
| Best PracticeReceive standard of care | Other | Arm B (standard of care) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (telehealth self-management coaching sessions), Arm B (standard of care) |
| InrweviewAncillary studies | Other | Arm A (telehealth self-management coaching sessions) |
Primary outcome
Patient reported quality of life (QOL)
Time frame: 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.
10 secondary outcomes
Enrollment rate
Time frame: Up to 25 months
Intervention completion rate
Time frame: Up to 6 months
Rate of participants completing any follow-up assessments
Time frame: Up to 6 months
Participant experience
Time frame: Up to 6 months
Patient reported symptom severity
Time frame: At baseline and at 3 and 6 months post randomization
Patient reported psychological distress
Time frame: At baseline and at 3 and 6 months post randomization
Family care giver (FCG) psychological distress
Time frame: At baseline and at 3 and 6 months post randomization
FCG caregiving burden
Time frame: At baseline and at 3 and 6 months post randomization
FCG QOL
Time frame: At baseline and at 3 and 6 months post randomization
Overall survival
Time frame: From initiation of intervention to death from any cause, up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided. not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent Chung, MD principal investigator
City of Hope Medical Center
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine, Counseling and Best Practice in people with Metastatic Pancreatic Adenocarcinoma, run by City of Hope Medical Center at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent Chung, MD (626-359-8111, vchung@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported quality of life (QOL) (time frame: At baseline and at 3 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.