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Behavioral Intervention
Digital Neurotherapy for Depression and Cognitive Improvement in Cancer Survivors
N/A
Recruiting
Led By Anushree Shirali, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 and older
Have received chemotherapy, and/or radiation treatment, and/or immunotherapy treatment for cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 8 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 am 18 years old or older.
Select...
I have undergone chemotherapy, radiation, or immunotherapy for cancer.
Select...
I am a cancer patient at Smilow Cancer Hospital.
Select...
I have undergone chemotherapy, radiation, or immunotherapy for cancer.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,843 Previous Clinical Trials
2,735,017 Total Patients Enrolled
63 Trials studying Depression
20,426 Patients Enrolled for Depression
Anushree Shirali, MDPrincipal InvestigatorYale University
Jennifer Kilkus, MDPrincipal InvestigatorYale University
Media Library
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.I am 18 years old or older.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 am a cancer patient at Smilow Cancer Hospital.I have brain cancer.I have undergone chemotherapy, radiation, or immunotherapy for 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies still available to participate in this research study?
"Per the clinicaltrials.gov entry, this medical trial is currently in search of participants. The experiment was first posted on December 17th 2021 and it has undergone a recent update on October 20th 2022."
Answered by AI
How many participants are being recruited for this experiment?
"Correct. Clinicaltrials.gov records indicate that the study, which began recruiting on December 17th 2021, is currently open for enrollment. A total of 50 participants need to be recruited from one medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
How old are they?
18 - 65
What site did they apply to?
Yale New Haven Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have tried at least 15 drugs that have not worked and many that have been detrimental.
PatientReceived 2+ prior treatments
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