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Clinical Trial Summary

The purpose of this research study is to develop and test an intervention designed to improve mood and reduce symptoms of depression.


Clinical Trial Description

Older African American/Black (AA/B) breast cancer survivors (BCS) experience high rates of depression and higher cancer-related mortality than non-Hispanic white BCS.Treating depression in BCS is critical since it is associated with poor health outcomes, in part due to its detrimental effect on health behaviors and high rate of relapse. Depression is an independent prognostic factor in BCS and associated with a 25% increased risk of cancer recurrence, 30% increased risk of all-cause mortality, and 29% increased risk of cancer-specific mortality. Clinical trials have found that treating depression in a cohort of women with metastatic breast cancer leads to an increase in survival. However, recent studies have found that depression is under-treated in participants with cancer, and despite increases in prescribing practices for antidepressants, rates of depression are steadily rising. Unfortunately, older adults and AA/Bs are both under-represented in clinical research and experience health disparities that limit access to evidence-based, culturally-relevant, depression interventions. In addition, current standard treatment of depression with anti-depressant medications is associated with poor adherence, side effects, unpredictable responsiveness, and have drug interactions with antineoplastic and endocrine therapy medications. Little is known regarding novel, non-pharmacological, treatments for depression in these populations, and reducing barriers to clinical trial participation is essential to develop new evidence-based approaches to depression for older AA BCS. Thus, it is critical to development non-pharmacological approaches for depression for older AA/B BCS and reduce barriers to clinical trial participation. Mindfulness-Based Cognitive Therapy (MBCT) is a group-based psychological intervention for depression that combines mindfulness training with cognitive therapy. MBCT reduces depressive symptoms in BCS, and the American Society of Clinical Oncology's (ASCO) guidelines recommend mindfulness-based interventions (MBIs), such as MBCT, for depression during and after cancer treatment. However, MBCT has significant time and logistical burden that limits clinical trial participation and clinical implementation due to its 8 weekly 2.5-hour in-person sessions. To address these barriers, investigators developed an abbreviated MBCT protocol (MBCT-Brief) that is remotely delivered and 8 weekly 1-hour sessions. However, no studies have adapted MBCT-Brief for the specific needs of older AA/B BCS (i.e. addressing psychological stressors specific to older AA/B BCS and including discussion of culturally relevant topics) or tested a culturally-adapted MBCT-Brief intervention in older AA/B BCS. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06336538
Study type Interventional
Source Case Comprehensive Cancer Center
Contact Jacob Hill, ND
Phone 216-695-4897
Email hillj35@ccf.org
Status Not yet recruiting
Phase N/A
Start date July 1, 2024
Completion date January 31, 2025

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