Trial Title:
MAAT For Young Adult Cancer Survivors
NCT ID:
NCT06150976
Condition:
Cancer
Conditions: Keywords:
Cancer
cancer survivorship
cancer-related cognitive impairment
CRCI
Cognitive-behavioral therapy
Memory Attention and Adaptation Training
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
MAAT-YS
Description:
MAAT is an evidence-based cognitive-behavioral therapy composed of eight 45-minute
telehealth appointments and an accompanying workbook.
Arm group label:
MAAT-YS Group
Summary:
The goal of this clinical trial is to pilot-test a modified version of
telehealth-delivered Memory and Attention Adaption Training (MAAT) that is tailored to
young adult childhood cancer survivors (ages 18-39; MAAT-YS) with cancer-related
cognitive impairment (CRCI). MAAT-YS consists of 8 weekly visits (45-minutes in duration)
and participants use a survivor workbook and complete homework between visits.
Participants in this single-group pilot trial (N=9) will complete online self-report
measures of cognitive symptoms, quality of life, treatment satisfaction and a brief
online neuropsychological test battery at baseline and post-MAAT-YS timepoints.
Detailed description:
The goal of this clinical trial is to pilot-test a modified version of
telehealth-delivered Memory and Attention Adaption Training (MAAT) that is tailored to
young adult childhood cancer survivors (ages 18-39; MAAT-YS) with cancer-related
cognitive impairment (CRCI). MAAT-YS consists of 8 weekly visits (45-minutes in duration)
and participants use a survivor workbook and complete homework between visits.
This pilot trial will determine MAAT-YS feasibility, treatment satisfaction and size of
effect in self-report and objective measures of neurocognitive function.
Eligible participants will be 9 individuals who were diagnosed with non-central-nervous
system (CNS) cancer (including leukemia/lymphoma without known CNS involvement) prior to
the age of 18, are at least 1-year from completion of cancer treatment, including
chemotherapy.
Participants will complete online self-report measures of cognitive symptoms, quality of
life, treatment satisfaction and a brief online neuropsychological test battery at
baseline and post-MAAT-YS timepoints.
If successful, further research is planned with a larger, multi-site randomized
controlled trial of MAAT-YS.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Adults aged 18-39
2. Diagnosed prior to 18 years of age with non-CNS solid tumor or leukemia/lymphoma
without known CNS involvement
3. At least 1 year after completion of treatment including chemotherapy, cancer-free
4. English fluent
5. Memory or other cognitive problems attributed to cancer and/or cancer treatment
6. Score of <10 on the FACT-Cog Impact on Quality of Life Scale
7. Willing to use telehealth with internet access
8. Willing to provide informed consent to participation
Exclusion Criteria:
1. Severe non-cancer brain injury such as severe traumatic brain injury, stroke or
toxic injury causing memory impairments;
2. Currently meeting Diagnostic and Statistical Manual-5 (DSM-5) criteria for a severe
psychiatric disorder, including substance abuse, mood, anxiety, or psychotic
disorders, as assessed by the PRIME-MD;
3. Scoring 3 or below on the 6-item cognitive screen designed to detect severe memory
disorders;59
4. Severe uncorrected sensory impairment (severe hearing or visual impairment).
Gender:
All
Minimum age:
18 Years
Maximum age:
39 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Indiana University School of Medicine
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Contact:
Last name:
Brenna Brenna, PsyD
Phone:
317-963-7502
Email:
mcdonalb@iupui.edu
Contact backup:
Last name:
Jessica N. Bailey, BS
Phone:
317-963-7516
Email:
jnadkins@iupui.edu
Investigator:
Last name:
Brenna C. McDonald, PsyD
Email:
Principal Investigator
Facility:
Name:
University of Pittsburgh School of Medicine/UPMC Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15213
Country:
United States
Contact:
Last name:
Chloe A Sinagra
Phone:
412-623-5888
Email:
chloe.sinagra@pitt.edu
Contact backup:
Last name:
University OPSOMHC Center, PHD
Phone:
412-623-5888
Email:
fergusonrj2@upmc.edu
Investigator:
Last name:
Robert J. Ferguson, PhD
Email:
Principal Investigator
Facility:
Name:
St. Jude Children's Research Hospital
Address:
City:
Memphis
Zip:
38105-3678
Country:
United States
Contact:
Last name:
Tara Brinkman, PHD
Phone:
901-595-5891
Email:
tara.brinkman@stjude.org
Contact backup:
Last name:
Stephanie Guthrie, RN, BSN, CCRP
Phone:
901-595-5143
Email:
stephanie.guthrie@stjude.org
Investigator:
Last name:
Tara Brinkman, PHD
Email:
Principal Investigator
Start date:
September 30, 2024
Completion date:
November 30, 2024
Lead sponsor:
Agency:
University of Pittsburgh
Agency class:
Other
Collaborator:
Agency:
St. Jude Children's Research Hospital
Agency class:
Other
Collaborator:
Agency:
Indiana University School of Medicine
Agency class:
Other
Source:
University of Pittsburgh
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06150976
