GIST and Memory and Attention Adaptation Training

NCT04879979 | Terminated

• 1 other identifier: HCC 20-117
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive-behavioral therapy (CBT) has been found to be efficacious in the treatment of cancer-related cognitive impairment (CRCI). Memory and Attention Adaptation Training (MAAT) has been evaluated in previous clinical trials with samples of breast cancer survivors and found effective at reducing cancer-related cognitive impairment. MAAT has been demonstrated to be efficacious when it is delivered via videoconference.The use of telehealth delivery enhances access to cancer survivorship care and reduces time and travel burden among cancer survivors, especially those who live in rural and/or underserved areas where cancer survivor services are less available. People with a diagnosis of gastrointestinal stromal tumors also experience self-reported cancer-related cognitive impairment. In order to determine if MAAT can sufficiently treat CRCI among people with gastrointestinal stromal tumors (GIST), we propose a trial of MAAT to determine its initial level of effectiveness in improving both self-reported cognitive impairments and objective neuropsychological test performance in GIST patients.

Conditions

GIST, Malignant; CBT

Keywords

GIST; MAAT; CBT

Outcome Measures

Primary Outcomes (3)

• California Verbal Learning Test-3 (CVLT-3)

  The California Verbal Learning Test is a neuropsychological assessment of episodic verbal and working memory. Participants listen to series of words and are then asked to recall the terms and the category to which they belong. This assessment attempts to measure how much a subject learned and also reveal strategies employed and the types of errors made. CVLT-3 measures both recall and recognition of two lists of words (List A and List B). Higher CVLT-3 scores (number of words recalled) are associated with better memory and processing function, therefore better outcome. Scores range from 0-16 for each word list where the higher the score the better the outcome.

  After 8 weekly MAAT visits (or up to 12 weeks if weekly visits are rescheduled)

• Controlled Oral World Association Test (COWAT)

  The Controlled Oral Word Association Test (COWAT), is a neuropsychological measure of verbal fluency. The COWAT consists of three word conditions. Participants are asked to produce as many words as they can that begin with the F, A, or S within a 1 minute time period. The total number of words that the individual is able to produce provides a score.

  After 8 weekly MAAT visits (or up to 12 weeks if weekly visits are rescheduled)

• Symbol Digit Modalities Test (SDMT)

  The Symbol Digit Modalities Test (SDMT) is a neurocognitive screening instrument used to assess neurological dysfunction. Participants are required to use a coded key to match nine abstract symbols paired with numerical digits. Ten (10) practice items before commencing the test. The final score is the correct number of substitutions in 90 seconds, and scores range between 0 and 110. Higher scores indicate better neurocognitive functioning.

  After 8 weekly MAAT visits (or up to 12 weeks if weekly visits are rescheduled)

Secondary Outcomes (5)

• FACT-Cog PCI

  After 8 weekly MAAT visits (or up to 12 weeks if weekly visits are rescheduled)

• PROMIS Item Bank -Emotional Distress - Short Form 8a

  After 8 weekly MAAT visits (or up to 12 weeks if weekly visits are rescheduled)

• PROMIS Item Bank: Anxiety- Short Form 8a.

  After 8 weekly MAAT visits (or up to 12 weeks if weekly visits are rescheduled)

• PROMIS Short Form: Fatigue 8a.

  After 8 weekly MAAT visits (or up to 12 weeks if weekly visits are rescheduled)

• PROMIS Short Form: Pain 3a.

  After 8 weekly MAAT visits (or up to 12 weeks if weekly visits are rescheduled)

Study Arms (1)

Memory and Attention Adaptation Training (MAAT)

EXPERIMENTAL

A cognitive-behavioral therapy (CBT) designed for the treatment of Cancer-Related Cognitive Impairment (CRCI)

Behavioral: MAAT

Interventions

MAAT BEHAVIORAL

MAAT consists of 8 weekly visits of 45 minutes duration and can be delivered effectively through videoconference technology (Vidyo). Participants will be asked to download the Vidyo App on their mobile phone or tablet. Vidyo is a HIPPA compliant, encrypted software with adequate bandwidth for highest quality videoconferencing intended for telehealth. It is the primary software for UPMC Telemedicine. Survivors are provided a workbook to reinforce learning, mastery and application of skills in daily life covered in each MAAT visit. The workbook provides reading structured within each of the 8 visits with guides for application of strategies as homework

Memory and Attention Adaptation Training (MAAT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above;
• Diagnosis of Gastrointestinal stromal tumor (GIST);
• At least 1 year post-initiation of TKI therapy;
• Report cognitive problems of memory and concentration attributed to GIST and/or treatment with a score of 10 or below on the FACT-Cog Impact on Quality of Life Scale;
• Able to speak and read English;
• Able to provide IRB-approved written informed consent; and
• Willingness to use videoconferencing and complete phone-based neurocognitive assessments

You may not qualify if:

• Previous treatment with a tyrosine kinase inhibitor medication for a non-GIST diagnosis
• Previous CNS radiation, intrathecal therapy, or CNS-involved surgery;
• Previous cancer history with the exception of non-melanoma skin cancer;
• Previous exposure to chemotherapy with another cancer or due to other medical condition (e.g., methotrexate exposure for treatment of rheumatoid arthritis);
• Scoring 3 or below on the 6-item cognitive screen designed to detect severe memory disorders;1
• Significant neurodevelopmental, neurobehavioral, or medical risk factors likely to affect cognitive functioning (e.g., history of neurological disorder, stroke, traumatic brain injury 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, uncontrolled diabetes or endocrine dysfunction);
• Current severe DSM-5 mental disorder criteria, including but not limited to neurodevelopmental, substance abuse, mood, anxiety, or psychotic disorders

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Robert J Ferguson, PhD

  University of Pittsburgh School of Medicine, UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

• Anette U Duensing, MD

  University of Pittsburgh School of Medicine, UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 10, 2021
• Study Start: January 12, 2021
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2022
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)