MAAT For Young Adult Cancer Survivors (MAAT-YACCS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: MAAT-YS

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.

• Study Type: Interventional
• Enrollment (Estimated): 9
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chloe A Sinagra; Phone Number: 412-623-5888; Email: chloe.sinagra@pitt.edu
• Study Contact Backup: Name: Robert J Ferguson, PHD; Email: fergusonrj2@upmc.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University school of Medicine
      • Contact: Brenna Brenna, PsyD; Phone Number: 317-963-7502; Email: mcdonalb@iupui.edu
      • Contact: Jessica N. Bailey, BS; Phone Number: 317-963-7516; Email: jnadkins@iupui.edu
      • Principal Investigator: Brenna C. McDonald, PsyD
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh School of Medicine/UPMC Hillman Cancer Center
      • Contact: Chloe A Sinagra; Phone Number: 412-623-5888; Email: chloe.sinagra@pitt.edu
      • Contact: University OPSOMHC Center, PHD; Phone Number: 412-623-5888; Email: fergusonrj2@upmc.edu
      • Principal Investigator: Robert J. Ferguson, PhD
  • Tennessee
    • Memphis, Tennessee, United States, 38105-3678
      • St. Jude Children's Research Hospital
      • Principal Investigator: Tara Brinkman, PHD
      • Contact: Tara Brinkman, PHD; Phone Number: 901-595-5891; Email: tara.brinkman@stjude.org
      • Contact: Stephanie Guthrie, RN, BSN, CCRP; Phone Number: 901-595-5143; Email: stephanie.guthrie@stjude.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MAAT-YS Group; This group will be treated with the MAAT-YS cognitive-behavioral therapy.	Behavioral: MAAT-YS; MAAT is an evidence-based cognitive-behavioral therapy composed of eight 45-minute telehealth appointments and an accompanying workbook.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) v.3. Impact on Quality-of-Life Scale (IQOL)	The IQOL assesses perceived quality of life impact of cognitive symptoms participants experience within a timeframe of the previous 7 days. It consists of 4 items with a 5-point Likert-type rating of 0 (Not at all) to 4 (Very Much) with a scoring range of 0-16. Scoring instructions indicate items are reverse scored, such that higher scores denote better quality of life, lower scores, poorer quality of life.	Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
Cognitive-Symptom-Checklist-Work-21 (CSC-W-21)	The CSC-W-21 is a 21-tem self-report measure of perceived impact of cognitive symptoms on work (occupational)-related tasks. Respondents are asked to indicate "yes" (1 point) or "no" (0 points) to each item. Higher scores, ranging from 0-21, denote more work-related cognitive symptoms.	Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
Metamemory in Adulthood-Anxiety Scale (MIA-A)	The MIA-A is a 14-item scale that uses a 5-point Likert-type rating for each item (1= Disagree Strongly; 5 Agree Strongly) with item 13 reverse scored. Items are summed with higher scores (range from 14-70) denoting more anxiety associated with perceived cognitive problems in daily life.	Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety v.1. - Short Form 4a	The PROMIS Anxiety v.1 Short Form 4a scale evaluates self-reported fearfulness, cognitive focus, and concentration, as well as emotional distress related to worry and feeling uneasy over the past 7 days. It consists of 4 items, each rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a scoring range of 4 to 20. Raw scores are converted to T-scores using PROMIS norms (mean = 50; SD = 10).Raw scores are converted to T-scores using PROMIS norms (mean = 50; SD = 10). Higher scores denote more anxiety.	Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression v.1. - Short Form 4a	The PROMIS Depression v.1 Short Form 4a scale evaluates self-reported negative mood, helpless and worthlessness over the past 7 days. It consists of 4 items, each rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a scoring range of 4 to 20. Raw scores are converted to T-scores using PROMIS norms (mean = 50; SD = 10). Higher scores denote more depression.	Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue v.1. - Short Form 4a	The PROMIS Fatigue v.1 Short Form 4a scale evaluates self-reported symptoms of exhaustion, fatigue and interference with daily activity over the past 7 days. It consists of 4 items, each rated on a 5-point scale (1=not at all; 2=a little bit; 3=somewhat; 4=quite a bit; and 5=very much) with a scoring range of 4 to 20. Raw scores are converted to T-scores using PROMIS norms (mean = 50; SD = 10). Raw scores are converted to T-scores using PROMIS norms (mean = 50; SD = 10). Higher scores denote more anxiety.	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	The PROMIS Global Health Physical scale is a self-report measure assessing physical health and ability. It consists of 2 items with a 5-point Likert-type rating of 1 (Poor) to 5 (Excellent) with a scoring range of 2-10. Raw scores are converted to T-scores using PROMIS norms (mean = 50; SD = 10). Higher scores denote better physical health.	Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2. Global Health - Mental 2a	The PROMIS Global Health Mental scale is a self-report measure assessing mental health and ability. It consists of 2 items with a 5-point Likert-type rating of 1 (Poor) to 5 (Excellent) with a scoring range of 2-10. Raw scores are converted to T-scores using PROMIS norms (mean = 50; SD = 10). Higher scores denote better mental health.	Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
Credibility/Expectancy Questionnaire (CEQ)	The CEQ is a self-report measure assessing the credibility and expectancy of treatment received. It consists of 6 items, 4 items with a 9-point Likert-type rating of 1 (not at all) to 5 (very much) with a scoring range of 3-27. The other 2 items are on a percentage scale from 0%-100% in increments of 10 with a scoring range of means 0-100%. Higher scores denote higher treatment credibility and expectancy.	Only administered after Visit 6 of MAAT-YS (after 6 weeks)
Treatment Satisfaction Questionnaire (TSS)	The Treatment Satisfaction (TSS) questionnaire is a self-report measure assessing satisfaction of treatment. It consists of 5 items with a 5-point Likert-type rating of 0 (not at all) to 8 (completely) with a scoring range of 0-40 and 1 additional yes/no item about whether traveling for treatment is possible for participation. Higher scores denote more satisfaction with treatment.	Post-MAAT-YS treatment only (8 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAAT-YS Fidelity Checklists	The MAAT-YS Fidelity Checklists assess the degree to which the MAAT-YS study clinician adheres to specific therapeutic behaviors of the MAAT-YS Clinician Manual. The checklists are administered to 2 independent treatment adherence raters who review randomly selected audio recordings of each of the 8 telehealth-delivered MAAT-YS visits. Behaviors in checklists per each visit are independently rated 0 (no or poor fidelity) to 10 (highest fidelity possible). Rating means are computed for each visit for a score of 0-10 with higher scores denoting higher treatment fidelity.	Immediately after the 6th visit of the MAAT intervention (6 weeks)

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: St. Jude Children's Research Hospital; Indiana University School of Medicine
• Investigators: Principal Investigator: Robert J Ferguson, PHD, UPMC Hillman Cancer Center/University of Pittsburgh School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Cognitive-behavioral therapy; cancer survivorship; cancer-related cognitive impairment; CRCI; Memory Attention and Adaptation Training
• Other Study ID Numbers: STUDY23030156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no data sharing plan with other institutions for this pilot trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No