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Search / Trial NCT05144516

Cancer and Mild Cognitive Impairment Dyadic Intervention

Launched by DUKE UNIVERSITY · Nov 22, 2021

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

Aging Behavioral Intervention Mental Health Communication

ClinConnect Summary

This clinical trial is looking to see if programs that involve both a cancer patient and their spouse or family caregiver can help families where one person has cancer and mild memory issues. Participants will join six online video sessions, lasting about an hour each, at times that work best for them. The study will provide a tablet (like an iPad) for these sessions and will teach participants how to use it. Before starting, and after the sessions, participants will fill out surveys to share their experiences, and this process will take around 2 to 4 months to complete.

To be eligible for this study, patients need to be at least 65 years old, have been diagnosed with certain types of cancer within the last two years, and have mild cognitive concerns. They should also be living at home and have a family caregiver who helps them. Caregivers must be 18 or older and spend a significant amount of time caring for the patient. It's important to note that both the patient and caregiver need to be able to communicate in English and learn how to use the tablet for the video sessions. If you or someone you know fits this description and is interested in participating, this study could be a valuable opportunity to receive support and help during a challenging time.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patient inclusion criteria include:
  • 1. Patients with Stage I-IV breast, colon, rectal, or lung cancer (diagnosed within two years); age 65 or older.
  • 2. Participants must be living at home (either in her/his own home).
  • 3. Participants must be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions.
  • 4. Exhibit Mild Cognitive Impairment/Concerns
  • 5. Have an informal family caregiver.
  • Inclusion Criteria:
  • (Partner or family member) inclusion criteria include:
  • 1. Caregivers are 18 older.
  • 2. Be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions.
  • 3. Either co-reside with the patient or spend at least 3-4 hours day caregiving.
  • 4. Not exhibit cognitive impairment.
  • Exclusion Criteria:
  • 1. Participant has visual or hearing impairments that preclude participation.
  • 2. Participant has dementia and do not have the capacity to participate.
  • 3. Have a serious untreated psychiatric illness as documented in medical chart review.
  • 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.

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Katherine Ramos, Ph.D.

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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