Testing Health-Related Interventions: Voices of Equity Needed to Overcome Weight-bias in Obesity-Cancer Care THRIVE NOW in Obesity-Cancer Care

Investigating Weight Management Strategies for Black Breast Cancer Survivors

M
Misty Hawkins

Primary Investigator

Enrolling By Invitation
21 years - 100 years
All
Phase N/A
10 participants needed
2 Locations

Brief description of 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.
 
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 
Phone: (317) 278-5632

Detailed description of 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)

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Cancer
  • Age: 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 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).
 

This study investigates the impact of weight-related interventions on Black Breast Cancer Survivors (BCS) with obesity. Black BCS often face unique challenges in managing their weight post-treatment, and this study aims to address these challenges. The study involves three phases, beginning with identifying risk and protective factors related to cancer-obesity multimorbidity. Participants will be involved in co-designing a tailored intervention to support successful breast cancer survivorship.

The study procedures include participating in surveys and intervention co-design sessions. Participants will take part in either in-person or virtual sessions to develop a weight management plan. The intervention's feasibility and acceptability will be tested on a small group, focusing on achieving a clinically significant weight loss over a short period.

  • Who can participate: Participants must be Black Breast Cancer Survivors aged 21 to 65, with a BMI of 30 or higher. They should have completed major cancer treatments at least two weeks but not more than six years ago. Participants must also be willing to complete an intervention co-design group and an 8-week program. Exclusions include a history of other cancers, recent significant weight loss, or participation in conflicting studies.
  • Study details: Participants will engage in co-design sessions to create a weight management plan. They will attend in-person and virtual sessions to discuss and develop strategies. The study will test if the intervention can lead to weight loss in a supportive environment over an 8-week program.
Updated on 30 Jul 2026. Study ID: HEWD-IIR-THRIVE-NOW, 21767
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only