Intervention for cancer patients with mild cognitive impairment and their caregivers

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

This study tests a video program designed to help cancer patients with mild cognitive issues and their caregivers improve communication and emotional support.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Duke University (other)
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT05144516 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of a dyadic intervention program for cancer patients experiencing mild cognitive impairment and their caregivers. Participants will engage in six 60-minute video-conference sessions, facilitated through a tablet computer provided by the study. Assessments will be conducted before, after, and one month post-intervention to measure outcomes related to cognitive and emotional well-being. The program focuses on enhancing communication and support within the patient-caregiver dyad.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 65 or older with Stage I-IV breast, colon, rectal, or lung cancer and mild cognitive impairment.

Not a fit: Patients with advanced dementia or significant visual or hearing impairments may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this intervention could improve the quality of life and cognitive functioning for cancer patients and their caregivers.

How similar studies have performed: Other studies have shown promise in dyadic interventions for chronic illnesses, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

Patient inclusion criteria include:

1. Patients with Stage I-IV breast, gastrointestinal (GI), genitourinary (GU), or lung cancer (including extensive stage small cell 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.

Where this trial is running

Durham, North Carolina

• Duke University — Durham, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Katherine Ramos, Ph.D. — Duke University
• Study coordinator: Katherine Ramos, Ph.D.

Conditions: Cancer, Cognitive Impairment, Aging, Behavioral Intervention, Mental Health, Communication