Cognitive Remediation Therapy (CRT) for Adults Treated for Cancer

NCT03285048 | Completed

• 1 other identifier: MIRB 02072 MB0018
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to determine the safety, feasibility and acceptability of an 8-week cognitive remediation training (CRT) in patients treated for cancer. The secondary objective of the study is to estimate the effect size of CRT in improving neurocognitive functioning and quality of life. This is a single-arm proof of concept study. Patients treated for cancer with persistent cognitive complaints will be recruited from the outpatient clinic of the VA Comprehensive Cancer Center, West Haven, CT, Yale Medicine, and greater New Haven community.The active treatment phase will be followed by an assessment at the conclusion of treatment to evaluate changes in cognitive function and quality of life. Participants will be invited back to participate in a final follow-up assessment 2 months later.

Conditions

Cancer of the Prostate; Cancer

Keywords

cognitive impairment

Outcome Measures

Primary Outcomes (1)

• Self-report of daily cognitive function

  Self-reported cognitive function includes symptoms of perceived cognitive impairments, perceived cognitive abilities, and overall quality of life. These are aggregated into a classification of overall degree of impairment and disability

  8 weeks

Secondary Outcomes (1)

• Neurocognitive function

  8 weeks

Study Arms (1)

Cognitive Remediation Therapy

EXPERIMENTAL

Cognitive Remediation Training is comprised of 8 weeks of active cognitive training using Brain HQ auditory and visual training tasks. Training is twice per week for up to 2 hours. Also included is a Bridging Group at each training session. The Bridging group provides information about cognitive training and compensatory strategies to generalize the benefits of training to daily life.

Behavioral: Cognitive Remediation Therapy

Interventions

Cognitive Remediation Therapy BEHAVIORAL

Brain HQ is a computer based cognitive training that uses hierarchical adaptive technology to provide challenging and demanding training that is not too frustrating or discouraging. Training includes auditory and visual sensory training, memory and executive function exercises. The Bridging group is based on similar training programs that focus on self-regulation training, problem focused cognitive behavior therapy and compensatory cognitive strategies.

Also known as: Cognitive Remediation Training

Cognitive Remediation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who:
• are at least six months from completion of adjuvant chemotherapy or chemoradiation and are in remission or;
• are receiving long-term chemotherapy (6 months or longer) with a diagnosis of Stage IV cancer and with stable medical conditions or;
• are receiving long-term (6 months or longer) hormone therapy (androgen deprivation therapy or anti-estrogen therapy). Patients in this group who received chemotherapy will be eligible if they completed chemotherapy at least 6 months prior to enrolling.
• \. Subjective reports of cognitive decline. 3. Report that they are interested in seeking treatment to address their cognitive concerns.
• \. Age 18 or older. 5. Fluency in English and a 6th grade or higher reading level.

You may not qualify if:

• Does not meet one of the three participant categories
• Unstable medical condition.
• History of, or current symptoms of, serious psychiatric disorder requiring antipsychotic medications or hospitalization.
• Current substance abuse disorder.
• History of, or current central nervous system (CNS) malignancies, CNS radiation, intrathecal chemotherapy, or CNS-involved surgery.
• Current IQ estimate less than 80.
• Unable to give written informed consent.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Morris D Bell, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: September 15, 2017
• Study Start: January 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 22, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)