Clinical trial NCT04961047: Feasibility and Efficacy of a Digital Neurotherapy Protocol for Management of Depression, Cognition, and Quality of Life in Cancer Survivors
Official title: Feasibility and Efficacy of a Digital Neurotherapy Protocol for Management of Depression, Cognition, and Quality of Life in Patients With Major Medical Illnesses
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Cognition
Quality of Life
Keywords: Cancer Survivor
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective, randomized clinical study to evaluate the feasibility and efficacy of a digital neurotherapy on depression, cognition, and quality of life in two groups of patients with major medical illness: 1) a sample of cancer survivors, and 2) a sample of patients with end stage kidney disease (ESKD) on dialysis.

Detailed description: This is a randomized, waitlist-control study to evaluate the feasibility and efficacy of an 8-week DNT intervention in patients with major medical illnesses. Waitlisted subjects will be given the option of receiving the DNT after completion of the waitlist period. Subjects will not be blinded to treatment condition.

Hypothesis 1: It is hypothesized that an 8-week DNT intervention will be feasible for 2 groups of patients with major medical illnesses: 1) a group of cancer survivors, and 2) a group of patients with ESKD on dialysis.

Hypothesis 2: It is hypothesized that this intervention will decrease depression symptoms, improve quality of life, and improve attention, executive functioning, and memory.

Study Procedures

General procedure: Potential subjects will be informed of the study and their option to participate by staff and providers during routine clinic visits to the Cancer Survivorship Program at Smilow Cancer Hospital and at routine clinic visits through Yale Nephrology. Interested individuals will be contacted by a member of the research team to assess eligibility. After providing informed consent, subjects will be randomly assigned to either the DNT group or to a waiting-list control group who will then be offered 8 weeks of DNT training at the completion of the final outcome assessment.

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. The Rejuvenate program has 7 different games that together train attention, reaction inhibition, cognitive flexibility, use of categories, pattern recognition, memory, dealing with distraction, and auditory and visual perception. In each training session participants do 4 training games for 5 minutes each. Before each 5-minute game, participants are offered three games to choose from. The program keeps track of all the games they choose, and if their training becomes too unbalanced, the games they have been choosing most often are not offered among the three choices until appropriate balance is restored.

Assessment: Assessments will be conducted at 3 intervals (baseline, midpoint, endpoint) for each subject assigned to the experimental group during the 8-week experimental intervention.

Eligibility criteria: Cancer Survivor Group

Inclusion Criteria:

1. Provision of signed and date informed consent form.
2. Stated willingness to comply with all study procedures and availability for the durationof the study.
3. Associated with Smilow Cancer Hospital with a diagnosis for cancer
4. Have received chemotherapy, and/or radiation treatment, and/or immuno therapy treatment for cancer
5. Able to understand and read English

Exclusion Criteria:

1. Stage 4 cancer
2. Brain cancer
3. Diagnosis of serious mental illness (ie, psychosis)
4. Cognitive impairment (ie, diagnosed dementia, intellectual development disorder)
5. Hearing or vision insufficient to do the computer exercises.

ESKD Group

Inclusion Criteria:

1. Associated with Yale Nephrology practice and receiving in-center hemodialysis treatment
2. Have received hemodialysis for at least one month from start of outpatient dialysis and attended 10 of first 12 visits.

Exclusion Criteria:

1. Diagnosis of serious mental illness (ie, psychosis)
2. Cognitive Impairment (ie, diagnosed dementia, intellectual development disorder)
3. Hearing or vision insufficient to do the computer exercises

Primary outcomes:
measure: Change in Hospital Anxiety and Depression Questionnaire
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in Patient Health Questionnaire-9
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in Functional Assessment of Cancer Therapy-General
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in Short-Form 36 Health Survey
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in Mindful Attention Awareness Scale
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in Flanker Task
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in List Sort Working Memory
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in Logical Memory
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in Multidimensional Executive Function Screening Test
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in Controlled Oral Word Association Test
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in California Verbal Learning Test-II
timeFrame: Baseline, 4 weeks, 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Anushree Shirali, MD
role: PRINCIPAL_INVESTIGATOR
References: