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Recruiting NCT06524973

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

No phase Interventional Metastatic Pancreatic Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Telemedicine, Counseling, Best Practice, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Metastatic Pancreatic Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Impacting Quality of Life and Pancreatic Cancer Survivorship Through a Telehealth Intervention

Overview

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

  • Other Telemedicine
    Attend telehealth self-management coaching sessions
  • Other Counseling
    Attend telehealth self-management coaching sessions
  • Other Best Practice
    Receive standard of care
  • Other Questionnaire Administration
    Ancillary studies
  • Other Inrweview
    Ancillary studies

Primary outcome measures

  • Patient reported quality of life (QOL) [Time frame: At baseline and at 3 months post randomization]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 22 centers
  • City of Hope at Arcadia — Arcadia
  • City of Hope Corona — Corona
  • City of Hope at Duarte — Duarte
  • City of Hope Comprehensive Cancer Center — Duarte
  • City of Hope at Glendale — Glendale
  • City of Hope at Glendora — Glendora
  • City of Hope Seacliff — Huntington Beach
  • City of Hope at Irvine Lennar — Irvine
  • … and 14 more centers

Identifiers

NCT: NCT06524973 · 24172 · NCI-2024-06078

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗