Breast Cancer Clinical Trial
Official title:
Community Engagement in the Development of an Abbreviated Mindfulness-Based Cognitive Therapy Intervention for Depression in Older African American/Black Breast Cancer Survivors (Community Minds)
The purpose of this research study is to develop and test an intervention designed to improve mood and reduce symptoms of depression.
Status | Not yet recruiting |
Enrollment | 31 |
Est. completion date | January 31, 2025 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - =65 years old - fluency in English - female - African American/Black - diagnosis of Stage I, II or III breast cancer - at least 3 months past active treatment for cancer (chemotherapy, surgery and/or radiation therapy) with no additional treatment scheduled except endocrine therapy - mild to moderate symptoms of depression (Patient Health Questionnaire-9(26) scores 4-14) - willing to be audio and video-recorded - willing to provide written informed consent. Exclusion Criteria: - moderately severe or severe depression (PHQ-9 scores =15) - comorbid psychiatric illness or other psychological disorders that would interfere with the ability to participate in or receive benefit from MBCT-Brief, including generalized social anxiety disorder, panic disorder, post-traumatic stress disorder, obsessive-compulsive disorder, drug abuse or dependence, bipolar disorder, borderline personality disorder, and active suicidal ideation. - changes in antidepressant medication within 6 weeks of intake - prior history of engaging in formal MBIs including Mindfulness-Based Stress Reduction, MBCT, Acceptance and Commitment Therapy, Dialectical Behavior Therapy - current daily meditation practice |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Department of Wellness and Preventive Medicine | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | Baseline, 8 weeks | |
Other | 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. | Baseline, 8 weeks | |
Other | 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. | Baseline, 8 weeks | |
Other | 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. | Baseline, 8 weeks | |
Primary | Mean participant attendance rate | Feasibility rate is measured by calculating the mean percent of intervention sessions attended by the participants | 8 weeks | |
Secondary | 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" | At 8 weeks |
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