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