RECRUITING

Cancer and Mild Cognitive Impairment Dyadic Intervention

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to see whether programs that include both a patient and their spouse or a patient and family caregiver (known as a dyad) are helpful for families in which one member of the dyad has cancer and mild memory difficulties and/or concerns. Participant and their spouse or participant and their family caregiver will have six, 60-minute video-conference sessions which will be scheduled at their convenience. The investigator will loan participants a tablet computer (iPad) to use for videoconferencing and train the participant in its use. Participant and their spouse or participant and their family caregiver will complete three assessments - one before starting the sessions, one after the sixth session, and one after 1 month. Each assessment will include surveys, which the participant will complete separately from their spouse or family caregiver. For most people, it will take upwards of 2 - 4 months to complete this study

Official Title

A Patient-Caregiver Behavioral Intervention for Older Adults With Cancer and Mild Cognitive Impairment-2

Quick Facts

Study Start:2024-09-30
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05144516

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:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients with Stage I-IV breast, colon, rectal, or lung cancer (diagnosed within two years); age 65 or older.
  2. 2. Participants must be living at home (either in her/his own home).
  3. 3. Participants must be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions.
  4. 4. Exhibit Mild Cognitive Impairment/Concerns
  5. 5. Have an informal family caregiver.
  1. 1. Participant has visual or hearing impairments that preclude participation.
  2. 2. Participant has dementia and do not have the capacity to participate.
  3. 3. Have a serious untreated psychiatric illness as documented in medical chart review.
  4. 4. The patient and the caregiver score less than a 3 on the National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) on a scale 0 to 10 to screen for distress. At least one dyad member must experience distress.

Contacts and Locations

Study Contact

Katherine Ramos, Ph.D.
CONTACT
9194163434
Katherine.Ramos@duke.edu
Kaylee Faircloth
CONTACT
9194163479
Kaylee.Faircloth@duke.edu

Principal Investigator

Katherine Ramos, Ph.D.
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke University
Durham, North Carolina, 27705
United States

Collaborators and Investigators

Sponsor: Duke University

  • Katherine Ramos, Ph.D., PRINCIPAL_INVESTIGATOR, Duke University

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

Study Start Date2024-09-30
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2024-09-30
Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

  • Aging
  • Behavioral Intervention
  • Mental Health
  • Communication

Additional Relevant MeSH Terms

  • Cancer
  • Cognitive Impairment