Cognitive Remediation Therapy (CRT) for Adults Treated for Cancer

Cancer Clinical Trial

— CaCRT  

Official title:

Cognitive Remediation Therapy (CRT) for Adults Treated for Cancer: A Single-arm Proof of Concept Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03285048
• Other study ID #: MIRB 02072 MB0018
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: September 2017

Study information

• Verified date: October 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Objectives:

The primary objective of this study is to determine the safety, feasibility and acceptability of an 8-week cognitive training intervention 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 for three different populations of cancer patients.

Research Design:

This is a single-arm proof of concept study with three cancer groups. 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. We intend to enroll approximately 30 participants, with approximately 10 from each of the following cancer treatment types (1) participants who are at least six months from completion of adjuvant chemotherapy or chemoradiation and are in remission; (2) participants who are receiving long-term chemotherapy (6 months or longer) with a diagnosis of Stage IV cancer and with stable medical condition; (3) participants who 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. There will be an eight-week intervention period and a two-month follow-up assessment.

Methodology:

Participants will participate in a pre-assessment to establish eligibility, baseline cognitive function, and quality of life. This will be followed by participation in a cognitive remediation program (Brain HQ) for eight weeks during which all participants receive up to 16 hours of computerized cognitive training and 16 45-minute Bridging groups where they learn cognitive skills for daily living. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1.Participants who:

1. are at least six months from completion of adjuvant chemotherapy or chemoradiation and are in remission or;

2. are receiving long-term chemotherapy (6 months or longer) with a diagnosis of Stage IV cancer and with stable medical conditions or;

3. 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.

2. Subjective reports of cognitive decline. 3. Report that they are interested in seeking treatment to address their cognitive concerns.

4. Age 18 or older. 5. Fluency in English and a 6th grade or higher reading level.

Exclusion Criteria:

1. Does not meet one of the three participant categories

2. Unstable medical condition.

3. History of, or current symptoms of, serious psychiatric disorder requiring antipsychotic medications or hospitalization.

4. Current substance abuse disorder.

5. History of, or current central nervous system (CNS) malignancies, CNS radiation, intrathecal chemotherapy, or CNS-involved surgery.

6. Current IQ estimate less than 80.

7. Unable to give written informed consent.

Related Conditions & MeSH terms

• Cancer
• Cancer of the Prostate
• Prostatic Neoplasms

Intervention

Behavioral:
• Cognitive Remediation Therapy
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.

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neurocognitive function	Neurocognitive assessments using neurocognitive tests of attention, processing speed, executive function and memory changes from baseline. Results are aggregated into an overall score reflecting neurocognitive change from baseline.	8 weeks