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NCT Number: NCT05144516

Cancer and Mild Cognitive Impairment Dyadic Intervention

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

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Key information

Conditions

Cancer Behavior Cognition Disorders Cognitive Dysfunction Cognitive Impairment Communication Mental Disorders Neoplasms Neurocognitive Disorders Personal Satisfaction Psychological Well-Being

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient inclusion criteria include:

  • 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.

Inclusion criteria

(Partner or family member) inclusion criteria include:

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Behavioral: COPE +

Behavioral

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

Primary outcomes

  1. Number of completed sessions as measured by enrollment log

    Time frame: Up to 17 Weeks

  2. 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

    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

Secondary outcomes

  1. Change in Distress as measured by the DASS-21

    Time frame: Baseline, up to 17 weeks, up to 1 month follow up

    The Depression, Anxiety, and Stress Scale (DASS-21) measure will be used for rating general distress across three emotional states of depression, anxiety, and stress. The measure has a total of 21 items. Scores range from 0- 63, with higher scores indicating greater distress.

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

    Time frame: Baseline, up to 17 weeks, up to 1 month follow up

    The Functional Assessment of Cancer Therapy: General (FACT-G) measure will be used for rating quality of life. The measure has a total of 27 items. Scores range from 0-108, with higher scores indicating greater quality of life.

  3. Change in Communication Patterns as measured by the CPQ-SF

    Time frame: Baseline, up to 17 weeks, up to 1 month follow up

    The Communication Patterns Questionnaire Short-Form (CPQ-SF) will be used for rating communication patterns in a relationship. The measure has a total of 11 items. Scores range from 11-99, higher scores indicate a greater likelihood of using a particular communication pattern during conflict interactions.

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

    Time frame: Baseline, up to 17 weeks, up to 1 month follow up

    The Mutuality Scale of the Family Care Inventory will be used for rating mutual concerns and overall relationship satisfaction. The measure consists of 15 items. Scores range from 0-60, higher scores indicate greater relationship satisfaction

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine Ramos, Ph.D.

CONTACT

[email protected]

9194163434

Kaylee Faircloth

CONTACT

[email protected]

9194163479

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 3, 2021
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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