GIST and Memory and Attention Adaptation Training

CBT Clinical Trial

— GIST-MAAT  

Official title:

Cognitive Impairment in GIST Patients on Tyrosine Kinase Inhibitor Therapy: Cognitive Behavioral Therapy to Improve Cognitive Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04879979
• Other study ID #: HCC 20-117
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2021
• Est. completion date: June 2028

Study information

• Verified date: May 2023
• Source: University of Pittsburgh
• Contact: Alicia Brindle
• Phone: 412-647-4817
• Email: alb330[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a single-group, repeated measures (pre-post-intervention) design. This low-cost, simple design is intended to gather pilot data to gain an understanding of preliminary MAAT efficacy in the population of people with GIST who have cognitive complaints. The objective of the study is to estimate the magnitude of clinical effect of MAAT (delivered via videoconference, telehealth technology) on perceived cognitive impairment and neuropsychological test performance among GIST patients with cognitive complaints. The primary objectives consist of the telephone-based assessment of neuropsychological status (TBANS) and self-reported cognitive symptoms as assessed by the FACT-Cog perceived cognitive impairments (PCI) scale and impact on quality of life scale (IQOL). Within-group effect size will be calculated to determine clinical effect of MAAT on group outcomes on neuropsychological and self-reported outcome measures (PCI, IQOL). The reliable change index (RCI) will be calculated to determine minimal clinically important differences in pre-to-post change in individual cases on FACT-Cog (PCI; IQOL) outcomes. The proportion of cases who exceed reliable change ("reliable" difference in pre-to-post-intervention FACT-Cog scores) will be quantified. The secondary objective is to estimate the magnitude of effect of MAAT on depressive symptoms, anxiety and fatigue among GIST patients with cognitive complaints. This will be done using a self-reported questionnaire (total scores/T-scores); a within-group effect size calculated to determine clinical effect of MAAT on group outcomes on self-reported outcome measures (PROMIS Depression 8a; PROMIS Anxiety 8a, PROMIS® Pain 3a, PROMIS® Fatigue 8a) and a within group effect size to determine clinical effect on group outcomes and published minimal clinically important differences in pre-to-post change individual cases. Screening will begin with individual patients diagnosed with GIST and who have either been directed by medical oncologists or those who respond to advertisements on clinic video monitors in waiting rooms, or who have responded to Pitt+Me recruitment methods. All participants in this study will be able to participate from home through the telephone (pre-post-MAAT, or intervention, neurocognitive assessments) and mobile device telehealth videoconference visits for 8 MAAT visits (intervention). Eligible and consented participants will have their first telephone-based neurocognitive assessment (TBANS) scheduled shortly after consent. At that point, a trained psychometrist (our research coordinator) will schedule the 30-minute telephone based and standardized neurocognitive assessment. Participants will also complete self-report measures online (REDCap) with data stored on secured University of Pittsburgh servers.Participants will then be enrolled in MAAT for 8 weekly visits of 45minutes each (described below). MAAT will be videoconference delivered by doctoral-level clinical psychology graduate student trainees who will be completing clinical externship with the Center for Counseling and Cancer Support at Hillman Cancer Center, Shadyside Medical Building. Dr. Ferguson will train and supervise each trainee delivering MAAT to assure highest quality control and treatment fidelity. After completion of 8 MAAT visits, participants will complete post-intervention measures consisting of the same measures they performed during the pre-intervention excluding demographic, clinical characteristics, and Charlson Comorbidity Index to evaluate participant change (efficacy) due to MAAT intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 and above;

2. Diagnosis of Gastrointestinal stromal tumor (GIST);

3. At least 1 year post-initiation of TKI therapy;

4. 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;

5. Able to speak and read English;

6. Able to provide IRB-approved written informed consent; and

7. Willingness to use videoconferencing and complete phone-based neurocognitive assessments

Exclusion Criteria:

1. Previous treatment with a tyrosine kinase inhibitor medication for a non-GIST diagnosis

2. Previous CNS radiation, intrathecal therapy, or CNS-involved surgery;

3. Previous cancer history with the exception of non-melanoma skin cancer;

4. Previous exposure to chemotherapy with another cancer or due to other medical condition (e.g., methotrexate exposure for treatment of rheumatoid arthritis);

5. Scoring 3 or below on the 6-item cognitive screen designed to detect severe memory disorders;1

6. 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);

7. Current severe DSM-5 mental disorder criteria, including but not limited to neurodevelopmental, substance abuse, mood, anxiety, or psychotic disorders

Related Conditions & MeSH terms

• CBT
• Gastrointestinal Stromal Tumors
• GIST, Malignant

Intervention

Behavioral:
• MAAT
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

Locations

Country	Name	City	State
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	FACT-Cog PCI	The FACT-Cog is a 37-item self-report measure that uses 5- point (0-4) Likert-type ratings that produce four scales: 1) Impact on quality of life; 2) Perceived cognitive impairments; 3) Comments from others; and 3) Perceived cognitive abilities. Higher scores indicate better function and quality of life on each scale. While each scale is scored and interpreted separately, they comprise the total Fact-cog assessment.	After 8 weekly MAAT visits (or up to 12 weeks if weekly visits are rescheduled)
Secondary	PROMIS Item Bank -Emotional Distress - Short Form 8a	This measure assesses self-reported negative mood, views of self, and social cognition, as well as decreased positive affect and engagement. It has 8 items on a 5-pt Likert Scale (1-5). Scores range from 8-40, where higher scores indicate more emotional distress.	After 8 weekly MAAT visits (or up to 12 weeks if weekly visits are rescheduled)
Secondary	PROMIS Item Bank: Anxiety- Short Form 8a.	Measures self-reported fear (fearfulness, panic), anxious misery (worry, dread), and hyperarousal (tension, nervousness, restlessness). It contains 8 items on a 5-pt Likert Scale (1-5). Scores range from 8-40, where higher scores indicate higher levels of anxiety.	After 8 weekly MAAT visits (or up to 12 weeks if weekly visits are rescheduled)
Secondary	PROMIS Short Form: Fatigue 8a.	Assesses subjective symptoms of fatigue from mild subjective feelings of tiredness to a sustained sense of exhaustion that interferes with function. It contains 8 items on a 5-pt Likert scale (1-5). Scores range from 8-40 where higher scores indicate higher levels of fatigue.	After 8 weekly MAAT visits (or up to 12 weeks if weekly visits are rescheduled)
Secondary	PROMIS Short Form: Pain 3a.	Assesses worst, average and current pain intensity. It contains 3 items on a 5 point Likert scale (1-5). Scores range from 3-15, where higher scores indicate higher levels of pain.	After 8 weekly MAAT visits (or up to 12 weeks if weekly visits are rescheduled)