Integrated Intervention for Breast Cancer Survivors With Diabetes

Summary

The purpose of this research study is to learn how therapy for breast cancer or DCIS/LCIS affects cognitive function and beliefs about cancer/DCIS/LCIS and diabetes (DM). For this portion of the study, the study team will integrate the information collected at previous follow-ups to create educational modules to change disease and medication beliefs and improve DM self-management behaviors (SMB). The educational counseling modules the study team plans to pilot test are rooted in the Common Sense Self-Regulation Model, a theory that posits that health behaviors are influenced by two parallel processes: cognitive (i.e., disease beliefs and expectations) and affective (i.e., emotional responses).

Conditions

• Diabetes
• Breast Cancer

Interventions

BEHAVIORAL

Integrated Intervention for Breast Cancer Survivors with Diabetes

All pilot participants will be required to have a SMB target to be included in this study. A SMB target will be chosen by the participant after reviewing their 18mo follow-up responses with the Care Coach. Participants may endorse a maladaptive belief or emotional response; however, this is not required to participate in this intervention. At each follow-up session, the Care Coach will review the participant's SMB goal and progress, address participant's challenges and suggest alternatives, and correct further misinformation on the disease(s). Additionally, the Care Coach will reinforce or introduce techniques that could help overcome barriers to reaching SMB goal and recommend participants to continue improving on the same goal or begin action planning towards a new SMB goal. 1. Just SMB concern 2. SMB + maladaptive belief + emotional response 3. SMB + maladaptive belief 4. SMB + emotional response

BEHAVIORAL

Attention Control

Participants in the control arm will receive a brochure to discuss healthy lifestyle behaviors to improve DM management. To control for the potentially confounding effect of personalized attention from the care coach on the relationship between the intervention and outcomes, participants also receive 4 calls to discuss study progress, thoughts and feelings about study/illness/behaviors, remind them about returning their pill bottles, and about scheduling for their upcoming 24mo follow-up study interview.

Sponsors & Collaborators

• Northwestern University Feinberg School of Medicine

  collaborator OTHER

• Feinstein Institute for Medical Research

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Icahn School of Medicine at Mount Sinai

  lead OTHER

Principal Investigators

• Jenny J. Lin, MD, MPH · Icahn School of Medicine at Mount Sinai

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-27

Primary Completion

2023-07-24

Completion

2023-07-24

Countries

• United States

Study Locations