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Completed
NCT07897890
Testing Health-Related Interventions: Voices of Equity Needed to Overcome Weight-bias in Obesity-Cancer Care
Conditions: Obesity & Overweight, Breast Cancer
Sex: Female
Ages: 21 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 12
Sponsor: Indiana University
Location: Regenstrief Institute Indianapolis Indiana
Summary
This study is testing an 8-week behavioral weight loss and wellness program adapted to the needs of Black/African American breast cancer survivors. The study will also examine psychological and physical factors that may be associated with weight loss outcomes.
Eligibility Criteria
Inclusion Criteria:
1. 21 to 65 years of age
2. 30 ≤ BMI kg/m2 \< 45
3. Identifies as Black or African American race
4. Patient has been diagnosed with stage I-IIIA breast cancer without evidence of distant disease at time of study entry.
5. Patient has completed surgery, radiation therapy, chemotherapy, and/or biologic therapy ≥2 weeks but ≤6 years prior (ongoing endocrine therapy is allowed).
6. Patient is willing to complete an 8-week in-person behavioral weight loss program
Exclusion Criteria:
1. Patient has a previous cancer diagnosis besides breast (non-melanoma skin cancer or melanoma in situ is allowed).
2. Patient is currently participating in ACT, CBT, formal mindfulness meditation training, or any other research study that has the potential to skew results of this study or the study in which the person is participating.
3. History of bariatric surgery or planning to get bariatric surgery over next 3 months
4. Pregnant or planning to become pregnant over next 3 months
5. Currently breastfeeding
6. History of or current serious eating disorder pathology
7. Current severe depression (≥ 5 on PHQ-2)
8. History of or current substance use disorder
9. History of hypomanic or manic episode
10. History of psychotic episode
11. History of neurological disorder or head injury (e.g., stroke, epilepsy, loss of consciousness \>10 min)
12. Recent significant weight loss (\>5% of total body weight)
13. Current Type I Diabetes
14. Disease that impacts weight (e.g., Cushing's syndrome, hypothyroidism).
Source: ClinicalTrials.gov (NCT07897890). StuddyBuddy aggregates publicly available trial information.