NCT05144516 · RECRUITING

Cancer and Mild Cognitive Impairment Dyadic Intervention

This trial is testing a behavioral support program called COPE+ for pairs of people — one with cancer and mild memory difficulties, plus their spouse or family caregiver. They meet together over six video sessions to learn coping strategies. Researchers are measuring whether the program reduces distress and improves functioning for both people. This is a Phase NA trial, meaning it is a feasibility or pilot study — early stage, not yet proven.

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.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-02-10

View full record on ClinicalTrials.gov

All APOE4 clinical trials