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Behavioral Intervention
Digital Neurotherapy for Depression and Cognitive Improvement in Cancer Survivors
N/A
Recruiting
Led By Jennifer Kilkus, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have received chemotherapy, and/or radiation treatment, and/or immunotherapy treatment for cancer
Be older than 18 years old
Must not have
Hearing or vision insufficient to do the computer exercises.
Brain cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 8 weeks
Awards & highlights
Summary
This trial will test whether a digital neurotherapy can help relieve depression, improve cognition, and quality of life in cancer survivors.
Who is the study for?
This trial is for adult cancer survivors from Smilow Cancer Hospital who have undergone chemotherapy, radiation, or immunotherapy. Participants must understand English and be willing to follow the study's procedures. Those with serious mental illness, cognitive impairment, severe hearing or vision issues, stage 4 cancer, or brain cancer cannot join.
What is being tested?
The study is testing a digital neurotherapy (DNT) treatment aimed at improving depression symptoms, cognition, and quality of life in cancer survivors. It's a randomized trial where participants are either placed in the DNT group or put on a wait list as a control.
What are the potential side effects?
Since this intervention involves non-invasive digital therapy rather than medication or surgery, significant side effects are not expected. However, participants may experience fatigue or discomfort from using digital devices.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have undergone chemotherapy, radiation, or immunotherapy for cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My hearing and vision allow me to do computer exercises.
Select...
I have brain cancer.
Select...
My cancer is at stage 4.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 weeks, 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks, 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in California Verbal Learning Test-II
Change in Controlled Oral Word Association Test
Change in Flanker Task
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Digital neurotherapy (DNT) TreatmentExperimental Treatment1 Intervention
The experimental group will have 8 weeks of DNT 4 times a week for 30 minutes in the participant's home. The computer-presented training will be done on the participants' tablets or personal computers with the Rejuvenate brain training program
Group II: Wait list control groupActive Control1 Intervention
Waiting-list control group participants will be offered 8 weeks of DNT training at the completion of the final outcome assessment.
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,907 Previous Clinical Trials
3,018,829 Total Patients Enrolled
64 Trials studying Depression
20,566 Patients Enrolled for Depression
Jennifer Kilkus, MDPrincipal InvestigatorYale University
Anushree Shirali, MDPrincipal InvestigatorYale University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with a serious mental illness such as psychosis.You are willing to comply with all study procedures and are available for the duration of the study.You have been diagnosed with a cognitive impairment, such as dementia or intellectual disability.My hearing and vision allow me to do computer exercises.You are able to understand and read English.I have undergone chemotherapy, radiation, or immunotherapy for cancer.I have brain cancer.My cancer is at stage 4.I am 18 years old or older.I am a cancer patient at Smilow Cancer Hospital.
Research Study Groups:
This trial has the following groups:- Group 1: Digital neurotherapy (DNT) Treatment
- Group 2: Wait list control group
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.
Depression Patient Testimony for trial: Trial Name: NCT04961047 — N/A
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