MAAT For Young Adult Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: MAAT-YS


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, cancer survivorship, cancer-related cognitive impairment, CRCI, Cognitive-behavioral therapy, Memory Attention and Adaptation Training