Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT05144516

Conditions

Cancer

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Behavioral: COPE +

Study Details

Brief summary:

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

Conditions

Cancer

Cognitive Impairment

Study ID

NCT05144516

Start date

Sep 30, 2024

Status verified date

Feb, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Patient Caregiver Dyad

Participants who are 65 years or older with cancer and mild cognitive impairment with their caregiver.

Interventions

Behavioral: COPE +

Six sixty minute sessions that teaches participants distress and communication coping skills.

Primary outcome measure

  • Number of completed sessions as measured by enrollment log [ Time Frame: Up to 17 Weeks ]
  • Number of participants who are satisfied with the intervention as measured by a score of 24 or greater on the CSQ-8 [ Time Frame: Up to 17 weeks ]

Central Contacts and Locations

Central contacts

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

More Information

Sponsor

Duke University

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • Aging
  • Behavioral Intervention
  • Mental Health
  • Communication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-02-10.