Cognitive Remediation Therapy (CRT) for Adults Treated for Cancer

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.

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.