NCT04826315

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
7mo left

Started Jan 2022

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Jan 2022Nov 2026

First Submitted

Initial submission to the registry

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

January 15, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

4.9 years

First QC Date

March 29, 2021

Last Update Submit

January 4, 2022

Conditions

CancerCognitive Impairment

Keywords

AgingBehavioral InterventionMental HealthCommunication

Outcome Measures

Primary Outcomes (2)

  • Number of completed sessions as measured by enrollment log

    Up to 10 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 10 weeks.

Secondary Outcomes (4)

  • Change in Distress as measured by the DASS-21

    Up to 10 weeks.

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

    Up to 10 weeks.

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

    Up to 10 weeks.

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

    Up to 10 weeks.

Study Arms (1)

Patient Caregiver Dyad

EXPERIMENTAL

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

Behavioral: COPE +

Interventions

COPE +BEHAVIORAL

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

Patient Caregiver Dyad

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Stage I-IV breast, colon, rectal, or lung cancer (newly diagnosed within 6 months; 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

NeoplasmsCognitive DysfunctionPsychological Well-BeingCommunication

Interventions

Coatomer Protein

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Coat Protein Complex IVesicular Transport ProteinsMembrane ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Katherine Ramos, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR
0

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

March 29, 2021

First Posted

April 1, 2021

Study Start

January 15, 2022

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)