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Behavioral Intervention for Cancer Patients with Cognitive Impairment (urochester Trial)
N/A
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 14
Awards & highlights
urochester Trial Summary
This trial will test whether a Dyadic Life Review (DLR), adapted from Life Review Therapy, can be done effectively over telehealth with caregivers of older cancer patients, including those with Mild Cognitive Impairment (MCI).
Who is the study for?
This trial is for older adults (65+) with advanced Stage III or IV cancer and their caregivers (50+). Participants must be able to consent, read English, and have decision-making capacity. At least 20 patients should show signs of Mild Cognitive Impairment. Those without decision-making ability or a health proxy, unable to identify a caregiver, or whose caregivers can't consent due to impairments are excluded.Check my eligibility
What is being tested?
The study tests the feasibility of Dyadic Life Review (DLR) therapy via telehealth for pairs ('dyads') consisting of an older adult with advanced cancer and their caregiver. It includes those with potential cognitive impairment and aims to adapt individual life review techniques for these dyads.See study design
What are the potential side effects?
Since DLR is a behavioral intervention involving discussions rather than medication, typical drug side effects aren't expected. However, participants may experience emotional discomfort discussing past experiences during sessions.
urochester Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
proportion of participants that complete the study
proportion of participants that consent who are approached for the study
proportion of participants who state the intervention is acceptable during a qualitative interview
Secondary outcome measures
mean change in Caregiver Reaction Scale for caregivers
mean change in Distress Thermometer and Problem list for caregivers
mean change in Dyadic Adjustment Scale-7 for caregivers
+7 moreurochester Trial Design
1Treatment groups
Experimental Treatment
Group I: Cancer PatientsExperimental Treatment1 Intervention
Dyadic Life Review will consist of 8 sessions delivered by a trained licensed clinician (i.e, the PI or other trained clinician) via video-conferencing in weekly sessions of 60 minutes.
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Who is running the clinical trial?
University of RochesterLead Sponsor
836 Previous Clinical Trials
518,070 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,644 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,669 Previous Clinical Trials
28,005,091 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have cancer that has reached Stage III or IV, regardless of the type of cancer.I'm sorry, it seems like the criterion you were about to mention got cut off. Could you please provide me with the full criterion so I can summarize it for you?You have advanced cancer, either Stage III or Stage IV, regardless of the type of cancer.You are 65 years old or older.You can read and understand English.You understand the study and are able to make your own decisions about participating. You will take a test to see if you can provide informed consent. The test will measure your understanding of the study and a score of >14.5 means you are able to make your own decisions.The study is looking for at least 20 patients with a high chance of Mild Cognitive Impairment based on their score of less than 26 on the Montreal Cognitive Assessment.
Research Study Groups:
This trial has the following groups:- Group 1: Cancer Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What results are scientists hoping to glean from this clinical endeavor?
"This trial's primary outcome will be measured after two weeks and is the percentage of participants that agree to join. Secondary outcomes include changes in Dyadic Adjustment Scale-7, UCLA Loneliness Score and PROMIS29 domains scores; all of which are graded on a scale from 0 - 10 with higher numbers suggesting worse results."
Answered by AI
Are there any available slots for participants in this research?
"Per the data hosted on clinicaltrials.gov, this medical experiment is actively enrolling patients. It was initially published on 28th March 2022 and its most recent update came through 15 June of that same year."
Answered by AI
How many volunteers are involved in this research endeavor?
"Affirmative. According to records accessible on clinicaltrials.gov, the trial first published in March 28th 2022 is presently recruiting for 80 candidates from a single site. The listing was most recently updated on June 15th 2022."
Answered by AI
Who else is applying?
What state do they live in?
New York
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
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