Cancer and Mild Cognitive Impairment Dyadic Intervention

NCT ID: NCT05144516

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2027-08-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patient Caregiver Dyad

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

Group Type: EXPERIMENTAL

Behavioral: COPE +

Intervention Type: BEHAVIORAL

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

Interventions

Behavioral: COPE +

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine Ramos, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Katherine Ramos, Ph.D.

Role: CONTACT

Katherine.Ramos@duke.edu

9194163434

Kaylee Faircloth

Role: CONTACT

Kaylee.Faircloth@duke.edu

9194163479

Other Identifiers

Pro00109148

Identifier Type: -

Identifier Source: org_study_id