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COPE+ Program for Cancer Patients with Cognitive Impairment

N/A
Recruiting
Led By Katherine Ramos, Ph.D.
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with Stage I-IV breast, colon, rectal, or lung cancer (diagnosed within two years); age 65 or older
Either co-reside with the patient or spend at least 3-4 hours day caregiving
Must not have
Participant has dementia and do not have the capacity to participate
Participant has visual or hearing impairments that preclude participation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 17 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether programs that include both a cancer patient and their spouse or family caregiver are helpful for families when the cancer patient has mild memory difficulties. Participants will have six, 60-minute video-conference sessions.

Who is the study for?
This trial is for people aged 65 or older with Stage I-IV breast, colon, rectal, or lung cancer diagnosed within the last two years. They must have mild cognitive issues and live at home with a family caregiver who spends 3-4 hours daily providing care. Both must speak English and be able to use a tablet for video calls. Excluded are those with serious untreated mental illness, dementia without capacity to participate, or insufficient distress levels.
What is being tested?
The study tests a program called COPE+ involving patients with cancer and mild memory problems along with their caregivers (dyads). They'll attend six one-hour video sessions via an iPad provided by the researchers. The goal is to assess if this dyadic intervention helps manage their conditions.
What are the potential side effects?
Since this trial involves behavioral interventions through video-conference sessions rather than medication, traditional side effects like you might see in drug trials are not expected. However, participants may experience emotional discomfort discussing sensitive topics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 65 or older with a recent diagnosis of breast, colon, rectal, or lung cancer.
Select...
I live with the patient or spend 3-4 hours a day caring for them.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have dementia and cannot make decisions for myself.
Select...
I do not have severe visual or hearing impairments that would stop me from participating.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 17 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 17 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants who are satisfied with the intervention as measured by a score of 24 or greater on the CSQ-8
Secondary study objectives
Change in Communication Patterns as measured by the CPQ-SF
Change in Distress as measured by the DASS-21
Change in Quality of Life as measured by the FACT-G
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patient Caregiver DyadExperimental Treatment1 Intervention
Participants who are 65 years or older with cancer and mild cognitive impairment with their caregiver.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,462 Previous Clinical Trials
2,964,280 Total Patients Enrolled
Katherine Ramos, Ph.D.Principal InvestigatorDuke University
3 Previous Clinical Trials
48 Total Patients Enrolled

Media Library

COPE + Clinical Trial Eligibility Overview. Trial Name: NCT05144516 — N/A
Cognitive Impairment Research Study Groups: Patient Caregiver Dyad
Cognitive Impairment Clinical Trial 2023: COPE + Highlights & Side Effects. Trial Name: NCT05144516 — N/A
COPE + 2023 Treatment Timeline for Medical Study. Trial Name: NCT05144516 — N/A
~53 spots leftby Aug 2027
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