ACTIVE_NOT_RECRUITING

Telehealth and Memory Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The overall purpose of this trial is to confirm the efficacy of Memory and Attention Adaptation Training (MAAT), a cognitive-behavioral therapy (CBT) for treatment of chemotherapy-related cognitive dysfunction among (female or male) breast cancer survivors. This is a multi-center, multi-clinician randomized control trial (MAAT vs. supportive therapy attention control condition). This trial will also evaluate a sub-sample of survivors pre-and post treatment with functional magnetic resonance imaging (fMRI) in a working memory task to evaluate pre-to-post treatment brain activation patterns to elucidate underlying mechanisms of clinical therapeutic change.

Official Title

Mobile Device CBT for Chemotherapy-Related Cognitive Dysfunction: A Multi-Center Randomized Controlled Trial

Quick Facts

Study Start:2021-03-18

Study Completion:2026-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04586530

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Diagnosis of stage I-III breast cancer 2. 1-5 years post-treatment and currently disease free 3. Treatment involved adjuvant or neoadjuvant chemotherapy 4. Report cognitive problems of memory and concentration attributed to chemotherapy with a score of 10 or below on the FACT-Cog Impact on Quality of Life Scale (a score \~1SD below pre-chemotherapy treatment norms; this criterion was used in our prior R21 study, ensures a clinically meaningful level of cognitive concerns,41 and discriminates high and low PCI scores in prior research42) 5. Able to speak and read English 6. Age \>18 7. Able to provide IRB-approved written informed consent 8. Willing to use videoconferencing.	1. Previous CNS radiation, intrathecal therapy, or CNS-involved surgery 2. Previous cancer history with the exception of non-melanoma skin cancer 3. Previous exposure to chemotherapy with another cancer or due to other medical condition (e.g., methotrexate exposure for treatment of rheumatoid arthritis) 4. Significant neurodevelopmental, neurobehavioral, or medical risk factors likely to affect cognitive functioning (e.g., history of neurological disorder or TBI of greater than mild severity, such as loss of consciousness \>30 minutes, medical disorder that is unstable or likely to affect cognition such as metabolic disorder, heart attack or stroke, uncontrolled diabetes or endocrine dysfunction) 5. Currently meeting DSM-5 mental disorder criteria, including but not limited to neurodevelopmental, substance abuse, mood (e.g., Maj.Dep), anxiety, or psychotic disorders 6. Scoring 3 or below on the 6-item cognitive screen designed to detect severe memory disorders;43 7. Severe uncorrected sensory impairment (severe hearing or visual impairment)

Inclusion Criteria

Exclusion Criteria

1. Diagnosis of stage I-III breast cancer
2. 1-5 years post-treatment and currently disease free
3. Treatment involved adjuvant or neoadjuvant chemotherapy
4. Report cognitive problems of memory and concentration attributed to chemotherapy with a score of 10 or below on the FACT-Cog Impact on Quality of Life Scale (a score \~1SD below pre-chemotherapy treatment norms; this criterion was used in our prior R21 study, ensures a clinically meaningful level of cognitive concerns,41 and discriminates high and low PCI scores in prior research42)
5. Able to speak and read English
6. Age \>18
7. Able to provide IRB-approved written informed consent
8. Willing to use videoconferencing.

1. Previous CNS radiation, intrathecal therapy, or CNS-involved surgery
2. Previous cancer history with the exception of non-melanoma skin cancer
3. Previous exposure to chemotherapy with another cancer or due to other medical condition (e.g., methotrexate exposure for treatment of rheumatoid arthritis)
4. Significant neurodevelopmental, neurobehavioral, or medical risk factors likely to affect cognitive functioning (e.g., history of neurological disorder or TBI of greater than mild severity, such as loss of consciousness \>30 minutes, medical disorder that is unstable or likely to affect cognition such as metabolic disorder, heart attack or stroke, uncontrolled diabetes or endocrine dysfunction)
5. Currently meeting DSM-5 mental disorder criteria, including but not limited to neurodevelopmental, substance abuse, mood (e.g., Maj.Dep), anxiety, or psychotic disorders
6. Scoring 3 or below on the 6-item cognitive screen designed to detect severe memory disorders;43
7. Severe uncorrected sensory impairment (severe hearing or visual impairment)

Contacts and Locations

Principal Investigator

Robert J Ferguson, PhD

PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Donna Posluszny, PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

Indiana University

Indianapolis, Indiana, 46202

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

Robert J Ferguson, PhD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital
Donna Posluszny, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-18

Study Completion Date2026-05-31

Study Record Updates

Study Start Date2021-03-18

Study Completion Date2026-05-31

Terms related to this study

Keywords Provided by Researchers

Memory and Attention Adaptation Training (MAAT)
cognitive-impairment
cancer survivorship

Additional Relevant MeSH Terms

Chemotherapy-related Cognitive Dysfunction