An interventional study of MBCT in Breast Cancer, Breast Cancer Female and Breast Cancer Stage I, sponsored by Case Comprehensive Cancer Center. Active, not recruiting at 1 site in United States. Open to female participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
The purpose of this research study is to develop and test an intervention designed to improve mood and reduce symptoms of depression.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 23 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
MBCT-Brief includes 8 weekly 1-hour group sessions delivered either via telephone or video teleconferencing. The decision to deliver the intervention either via phone or teleconferencing will be made based on participant preference obtained during the formative focus groups. Telephone delivery of MBCT-Brief only requires a landline, while teleconferencing requires either a smartphone, tablet, or computer with audio and video functionality. During the MBCT-Brief intervention the instructor will lead in-session practice of medication and cognitive therapy exercises, guided inquiry, and assign and review at-home practice exercises. All sessions will be audio-recorded. Participants will be encouraged to practice daily meditation in between group sessions for 20 minutes, 6 days per week. Participants will complete practice logs to document daily meditation practice.
Other: MBCT
Mindfulness-Based Cognitive Therapy (MBCT) is a group-based psychological intervention for depression that combines mindfulness training with cognitive therapy.
Mean participant attendance rate
Feasibility rate is measured by calculating the mean percent of intervention sessions attended by the participants
Time frame: 8 weeks
Acceptability rate using CSQ(Client Satisfaction Questionnaire-8)
This is an 8-item self-report measure where response options are coded on a 4-point scale and summed to produce a total score ranging from 8-32. A mean score of ≥25 on the CSQ is considered "high satisfaction"
Time frame: At 8 weeks
Change in fear of recurrence as assessed using FCRI(Fear of Cancer Recurrence Inventory) scores
Pre/post change in FCRI scores, ranging from 0 to 4 where 0 indicates none and 4 indicates a great deal, will be calculated to examine intervention-related differences in fear of recurrence
Time frame: Baseline, 8 weeks
Change in trait mindfulness as assessed using FFMQ-15(Five Facet of Mindfulness Scale Short Form) scores
Pre/post change in FFMQ-15 scores will be calculated, and these scores will be used in models to predict change in patient reported outcomes. The FFMQ measures pre-post trait mindfulness and is assessed using 15 items that index the degree to which participants experience daily mindfulness, a central objective of the MBCT-Brief intervention. Each item is rated on a 5-point scale from '1' = never or very rarely true to '5' = very often or always true. Scores range from 15-75, with higher scores reflecting greater trait mindfulness.
Time frame: Baseline, 8 weeks
Change in Quality of life as assessed using ICS-2(Impact of Cancer Scale version 2) scores
Pre/post change in ICS-2 scores, ranging from 1-5, where 1 is strongly disgaree and 5 is strongly agree, will be calculated to examine intervention-related differences in quality of life. It consists of a positive impact summary scale with four subscales (altruism and empathy, health awareness, meaning of cancer, and positive self-evaluation), a negative impact summary scale with four subscales (appearance concerns, body change concerns, life interferences, and worry), and subscales for employment and relationship concerns.
Time frame: Baseline, 8 weeks
Change in depressive symptoms as assessed using PROMIS-D(Patient Reported Outcomes Measurement Information System-Depression) scores
Responses categorized as 'never,' 'rarely,' 'sometimes,' 'often,' and 'always' with assigned points of 1, 2, 3, 4, and 5 respectively. A pre/post change of ≥3 points is considered minimally important clinical difference for change in depressive symptoms.
Time frame: Baseline, 8 weeks
Plan to share: Yes — De-identified individual data set from the single arm pilot trail that underlie the results in publication will be shared
Supporting information: Icf, Analytic code
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Case Comprehensive Cancer Center