Telehealth intervention for improving memory in breast cancer survivors
Mobile Device CBT for Chemotherapy-Related Cognitive Dysfunction: A Multi-Center Randomized Controlled Trial
This study is testing a new online therapy to see if it can help breast cancer survivors improve their memory and attention after chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | chemotherapy, radiation, methotrexate |
| Locations | 2 sites (Indianapolis, Indiana and 1 other locations) |
| Trial ID | NCT04586530 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of Memory and Attention Adaptation Training (MAAT), a cognitive-behavioral therapy designed to address chemotherapy-related cognitive dysfunction in breast cancer survivors. Participants will be randomly assigned to receive either MAAT or supportive therapy over an 8-week period, with both interventions delivered via videoconferencing to enhance accessibility. The study will also utilize functional magnetic resonance imaging (fMRI) to assess brain activation patterns before and after treatment, providing insights into the mechanisms of cognitive improvement. Outcome measures will include self-reported cognitive function and objective neurocognitive test scores, assessed at the end of treatment and at a 6-month follow-up.
Who should consider this trial
Good fit: Ideal candidates are breast cancer survivors who are 1-5 years post-chemotherapy treatment and report cognitive difficulties related to their cancer treatment.
Not a fit: Patients with a history of central nervous system radiation or other significant neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve cognitive functioning and quality of life for breast cancer survivors experiencing cognitive impairments post-chemotherapy.
How similar studies have performed: Previous studies have shown promise in cognitive-behavioral therapies for similar cognitive impairments, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: 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)
Where this trial is running
Indianapolis, Indiana and 1 other locations
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Robert J Ferguson, PhD — St. Jude Children's Research Hospital
- Study coordinator: Chloe M Sinagra, B.S.
- Email: sinagrac@upmc.edu
- Phone: 412-623-5975
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.