Cancer and Mild Cognitive Impairment Dyadic Intervention

NCT05144516 | Recruiting

• 1 other identifier: Pro00109148
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Aging; Behavioral Intervention; Mental Health; Communication

Outcome Measures

Primary Outcomes (2)

• Number of completed sessions as measured by enrollment log

  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

  The Client Satisfaction Questionnaire (CSQ-8) is a self report measure of satisfaction with health and behavioral services received. The CSQ-8 is measured on a four point Likert scale from 1 "Quite Dissatisfied" to 4 "Very Satisfied." Scores range from 8-32, with higher values indicating higher satisfaction

  Up to 17 weeks

Secondary Outcomes (4)

• Change in Distress as measured by the DASS-21

  Baseline, up to 17 weeks, up to 1 month follow up

• Change in Quality of Life as measured by the FACT-G

  Baseline, up to 17 weeks, up to 1 month follow up

• Change in Communication Patterns as measured by the CPQ-SF

  Baseline, up to 17 weeks, up to 1 month follow up

• Change in Relationship Satisfaction as measured by the Mutuality Scale of the Family Care Inventory

  Baseline, up to 17 weeks, up to 1 month follow up

Study Arms (1)

Patient Caregiver Dyad

EXPERIMENTAL

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

Behavioral: Behavioral: COPE +

Interventions

Behavioral: COPE + BEHAVIORAL

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

Patient Caregiver Dyad

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participants must be living at home (either in her/his own home).
• Participants must be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions.
• Exhibit Mild Cognitive Impairment/Concerns
• Have an informal family caregiver.
• Caregivers are 18 older.
• Be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions.
• Either co-reside with the patient or spend at least 3-4 hours day caregiving.
• Not exhibit cognitive impairment.

You may not qualify if:

• Participant has visual or hearing impairments that preclude participation.
• Participant has dementia and do not have the capacity to participate.
• Have a serious untreated psychiatric illness as documented in medical chart review.
• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Cognitive Dysfunction; Psychological Well-Being; Communication

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Katherine Ramos, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Ramos, Ph.D.

CONTACT

9194163434; Katherine.Ramos@duke.edu

Kaylee Faircloth

CONTACT

9194163479; Kaylee.Faircloth@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: September 30, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)