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COPE+ Program for Cancer Patients with Cognitive Impairment

N/A

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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I live with the patient or spend 3-4 hours a day caring for them.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of completed sessions as measured by enrollment log

Number of participants who are satisfied with the intervention as measured by a score of 24 or greater on the CSQ-8

Secondary outcome measures

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

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,358 Previous Clinical Trials

3,419,965 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial accept elderly participants?

"To be admitted into this medical trial, applicants must fall within the age bracket of 18 to 100. Meanwhile, 89 studies cater to minors and 997 studies focus on those aged over 65."

Answered by AI

Are there any opportunities to join this clinical experiment currently available?

"Data retrieved from clinicaltrials.gov has confirmed that, while this medical trial was originally published on October 1st 2023 and last amended on 10/6/2022, it is no longer actively enrolling patients. Nevertheless, there are still over a thousand other trials presently recruiting participants."

Answered by AI

Am I eligible to take part in this clinical trial?

"This clinical trial is searching for 144 people with a malignancy between the ages of 18 and 100. To be eligible, participants must possess fluency in English and demonstrate competence using tablet computers to take part in video conferences. Furthermore, patients should have Stage I-IV breast, colon, rectal or lung cancer (diagnosed within 6 months), exhibit Mild cognitive impairment/Concerns and cohabit or spend at least 3-4 hours per day providing caregiving services to the patient. Additionally, they are required to have an informal family caregiver who is over 18 years old and not suffer from cognitive impairment themselves."

Answered by AI

What is the desired outcome of this research?

"The primary assessment of this trial, measured over the course of 10 weeks, will be patient satisfaction determined by a score on CSQ-8 greater than 24. Secondary outcomes include quality of life as gauged by FACT-G (0-108), distress levels assessed through DASS-21 (0 - 63) and relationship satisfaction evaluated with Mutuality Scale from Family Care Inventory (0 - 60)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cancer and Mild Cognitive Impairment Dyadic Intervention

2024. "Cancer and Mild Cognitive Impairment Dyadic Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05144516.

All > Mild Cognitive Impairment