Testing Health-Related Interventions: Voices of Equity Needed to Overcome Weight-bias in Obesity-Cancer Care THRIVE NOW in Obesity-Cancer Care
M
Misty Hawkins
Primary Investigator
Enrolling By Invitation
21-100 years
All
Phase
N/A
10 participants needed
2 Locations
Brief description of study
What is the purpose of this study?
There are long-standing inequities in interventions for obesity among Black Breast Cancer Survivors (BCS). While the American Cancer Society provides recommendations regarding weight management for successful cancer survivorship, the guidelines are not specific to women or Blacks. This 3-phase pilot study will address these inequities by inviting Black BCS with obesity to contribute their voice in the development of a weight-related intervention for successful breast cancer survivorship and then test preliminary feasibility/acceptability and efficacy.
There are long-standing inequities in interventions for obesity among Black Breast Cancer Survivors (BCS). While the American Cancer Society provides recommendations regarding weight management for successful cancer survivorship, the guidelines are not specific to women or Blacks. This 3-phase pilot study will address these inequities by inviting Black BCS with obesity to contribute their voice in the development of a weight-related intervention for successful breast cancer survivorship and then test preliminary feasibility/acceptability and efficacy.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
Phase 1: Identify differences in risk and protective factors related to
cancer-obesity multimorbidity among an initial sample of ~100 BCS (any
race-ethnicity).
Phase 2: Tailor a behavioral obesity intervention for Black BCS
with BMI > 30 kg/m2 in co-design collaboration with 5 Black BCS
Phase
3: Determine the feasibility and acceptability of the tailored
intervention in generating weight loss for a open pilot sample of 15
Black BCS
Feasibility defined as >75% retention of participants completing weight loss protocol
Acceptability defined as >80% participants endorsing intervention as acceptable to them and would recommend to others
Generates clinically significant weight loss within the expected time frame (1.5-3% total body weight loss in 8 weeks)
Feasibility defined as >75% retention of participants completing weight loss protocol
Acceptability defined as >80% participants endorsing intervention as acceptable to them and would recommend to others
Generates clinically significant weight loss within the expected time frame (1.5-3% total body weight loss in 8 weeks)
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Breast Cancer
-
Age: Between 21 Years - 100 Years
-
Gender: All
Phase 1
Inclusion criteria:
1. ≥21 years of age
2. Patient has been diagnosed with stage I-IIIA breast cancer without evidence of distant disease at time of study entry.
3. Patient has completed surgery, radiation therapy, chemotherapy, and/or biologic therapy ≥2 weeks but ≤6 years prior (ongoing endocrine therapy is allowed).
4. Patient is willing to complete the survey.
Phases 2 and 3
Inclusion:
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 intervention co-design group (2 in-person sessions, 2 virtual; Phase 2 over 6-8 weeks) or an 8-week in-person behavioral weight loss program (Phase 3).
Exclusion:
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).
Inclusion criteria:
1. ≥21 years of age
2. Patient has been diagnosed with stage I-IIIA breast cancer without evidence of distant disease at time of study entry.
3. Patient has completed surgery, radiation therapy, chemotherapy, and/or biologic therapy ≥2 weeks but ≤6 years prior (ongoing endocrine therapy is allowed).
4. Patient is willing to complete the survey.
Phases 2 and 3
Inclusion:
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 intervention co-design group (2 in-person sessions, 2 virtual; Phase 2 over 6-8 weeks) or an 8-week in-person behavioral weight loss program (Phase 3).
Exclusion:
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).
Updated on
01 Aug 2024.
Study ID: IUSCCC-0856, HEWD-IIR-THRIVE-NOW, 21767
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