Clinical trial NCT06150976: MAAT For Young Adult Cancer Survivors
Official title: Modifying Memory and Attention Adaptation Training (MAAT) For Young Adult Childhood Cancer Survivors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Cancer
cancer survivorship
cancer-related cognitive impairment
CRCI
Cognitive-behavioral therapy
Memory Attention and Adaptation Training
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: St. Jude Children's Research Hospital
name: Indiana University School of Medicine
First posted: 2023-11-30
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) v.3. Perceived Cognitive Impairments Scale (PCI)
timeFrame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
measure: CNS Vital Signs (CNSVS) Online Neuropsychological Test Battery (1) Verbal Memory (VBM) (recognition memory for words)
timeFrame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
measure: CNS Vital Signs (CNSVS) Online Neuropsychological Test Battery (2) Symbol Digit Coding (SDC) (visual motor processing speed)
timeFrame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
measure: CNS Vital Signs (CNSVS) Online Neuropsychological Test Battery (3) Stroop Test (ST) (visual motor reaction time, processing speed and visual discrimination)
timeFrame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
measure: CNS Vital Signs (CNSVS) Online Neuropsychological Test Battery (4) 4-Part Continuous Performance Test (FPCPT) (sustained attention and working memory)
timeFrame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT visits)
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) v.3. Impact on Quality-of-Life Scale (IQOL)
timeFrame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
measure: Cognitive-Symptom-Checklist-Work-21 (CSC-W-21)
timeFrame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
measure: Metamemory in Adulthood-Anxiety Scale (MIA-A)
timeFrame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety v.1. - Short Form 4a
timeFrame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Depression v.1. - Short Form 4a
timeFrame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue v.1. - Short Form 4a
timeFrame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2. Global Health - Physical 2a
timeFrame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2. Global Health - Mental 2a
timeFrame: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
measure: Credibility/Expectancy Questionnaire (CEQ)
timeFrame: Only administered after Visit 6 of MAAT-YS (after 6 weeks)
measure: Treatment Satisfaction Questionnaire (TSS)
timeFrame: Post-MAAT-YS treatment only (8 weeks)
Other outcomes:
measure: MAAT-YS Fidelity Checklists
timeFrame: Immediately after the 6th visit of the MAAT intervention (6 weeks)
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine/UPMC Hillman Cancer Center
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: UPMC Hillman Cancer Center/University of Pittsburgh School of Medicine
name: Robert J Ferguson, PHD
role: PRINCIPAL_INVESTIGATOR
References: