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Clinical Trials/NCT06150976
NCT06150976
Completed
Not Applicable

Modifying Memory and Attention Adaptation Training (MAAT) For Young Adult Childhood Cancer Survivors

University of Pittsburgh3 sites in 1 country7 target enrollmentFebruary 12, 2025
ConditionsCancer
InterventionsMAAT-YS

Overview

Phase
Not Applicable
Intervention
MAAT-YS
Conditions
Cancer
Sponsor
University of Pittsburgh
Enrollment
7
Locations
3
Primary Endpoint
CNS Vital Signs (CNSVS) Online Neuropsychological Test Battery (3) Stroop Test (ST) (visual motor reaction time, processing speed and visual discrimination)
Status
Completed
Last Updated
3 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 12, 2025
End Date
September 5, 2025
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Donna Posluszny

Associate Professor

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18-39
  • Diagnosed prior to 18 years of age with non-CNS solid tumor or leukemia/lymphoma without known CNS involvement
  • At least 1 year after completion of treatment including chemotherapy, cancer-free
  • English fluent
  • Memory or other cognitive problems attributed to cancer and/or cancer treatment
  • Score of \<10 on the FACT-Cog Impact on Quality of Life Scale
  • Willing to use telehealth with internet access
  • Willing to provide informed consent to participation

Exclusion Criteria

  • Severe non-cancer brain injury such as severe traumatic brain injury, stroke or toxic injury causing memory impairments;
  • 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;
  • Scoring 3 or below on the 6-item cognitive screen designed to detect severe memory disorders;59
  • Severe uncorrected sensory impairment (severe hearing or visual impairment).

Arms & Interventions

MAAT-YS Group

This group will be treated with the MAAT-YS cognitive-behavioral therapy.

Intervention: MAAT-YS

Outcomes

Primary Outcomes

CNS Vital Signs (CNSVS) Online Neuropsychological Test Battery (3) Stroop Test (ST) (visual motor reaction time, processing speed and visual discrimination)

Time Frame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)

CNSVS Stroop Test (ST) is a computer-based neuropsychological test of visual motor reaction time, processing speed and visual discrimination. The test is measured in standard score units (Mean of 100; SD 15). Higher scores denote better cognitive function.

CNS Vital Signs (CNSVS) Online Neuropsychological Test Battery (1) Verbal Memory (VBM) (recognition memory for words)

Time Frame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)

CNSVS Verbal Memory (VBM) is a computer-based neuropsychological test of word recognition and memory for words). The test is measured in standard score units (Mean of 100; SD 15). Higher scores denote better cognitive function.

CNS Vital Signs (CNSVS) Online Neuropsychological Test Battery (4) 4-Part Continuous Performance Test (FPCPT) (sustained attention and working memory)

Time Frame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT visits)

CNSVS 4-Part Continuous Performance Test (FPCPT) is a computer-based neuropsychological test of sustained attention and working memory. The test is measured in standard score units (Mean of 100; SD 15). Higher scores denote better cognitive function.

Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) v.3. Perceived Cognitive Impairments Scale (PCI)

Time Frame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)

The PCI assesses perceived cognitive function of participants within a timeframe of the previous 7 days. It consists of 18 items with a 5-point Likert-type rating of 0 (Never) to 4 (Several times a day) with a scoring range of 0-72. Scoring instructions indicate items are reverse scored, such that higher scores denote better perceived cognitive function, lower scores, poorer cognitive function.

CNS Vital Signs (CNSVS) Online Neuropsychological Test Battery (2) Symbol Digit Coding (SDC) (visual motor processing speed)

Time Frame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)

CNSVS Symbol Digit Coding (SDC) is a computer-based neuropsychological test of visual motor processing speed. The test is measured in standard score units (Mean of 100; SD 15). Higher scores denote better cognitive function.

Secondary Outcomes

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2. Global Health - Mental 2a(Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits))
  • Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) v.3. Impact on Quality-of-Life Scale (IQOL)(Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits))
  • Metamemory in Adulthood-Anxiety Scale (MIA-A)(Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits))
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Depression v.1. - Short Form 4a(Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits))
  • Credibility/Expectancy Questionnaire (CEQ)(Only administered after Visit 6 of MAAT-YS (after 6 weeks))
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue v.1. - Short Form 4a(Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits))
  • Cognitive-Symptom-Checklist-Work-21 (CSC-W-21)(Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits))
  • Treatment Satisfaction Questionnaire (TSS)(Post-MAAT-YS treatment only (8 weeks))
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety v.1. - Short Form 4a(Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits))
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2. Global Health - Physical 2a(Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits))

Study Sites (3)

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