MAAT For Young Adult Cancer Survivors

NCT06150976 | Completed DMC

• 1 other identifier: HCC 23-043
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Keywords

Cancer; cancer survivorship; cancer-related cognitive impairment; CRCI; Cognitive-behavioral therapy; Memory Attention and Adaptation Training

Outcome Measures

Primary Outcomes (5)

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

  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.

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

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

  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.

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

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

  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.

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

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

  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.

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

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

  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.

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

Secondary Outcomes (10)

• 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)

• Cognitive-Symptom-Checklist-Work-21 (CSC-W-21)

  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) Anxiety v.1. - Short Form 4a

  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)

Other Outcomes (1)

• MAAT-YS Fidelity Checklists

  Immediately after the 6th visit of the MAAT intervention (6 weeks)

Study Arms (1)

MAAT-YS Group

EXPERIMENTAL

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

Behavioral: MAAT-YS

Interventions

MAAT-YS BEHAVIORAL

MAAT is an evidence-based cognitive-behavioral therapy composed of eight 45-minute telehealth appointments and an accompanying workbook.

MAAT-YS Group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Pittsburgh: lead
• Indiana University School of Medicine: collaborator
• St. Jude Children's Research Hospital: collaborator

Study Sites (3)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

University of Pittsburgh School of Medicine/UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15213, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105-3678, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Robert J Ferguson, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

• Donna Posluszny, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 30, 2023
• Study Start: February 12, 2025
• Primary Completion: September 5, 2025
• Study Completion: September 5, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)