Integrated Intervention for Breast Cancer Survivors With Diabetes

NCT05092477 | Completed

• 2 other identifiers: GCO 17-00563R01CA214491
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Breast Cancer; Intervention; Diabetes; Motivational Interviewing; Cognitive Restructuring; Emotional Response Management

Outcome Measures

Primary Outcomes (1)

• Illness Perceptions Questionnaire (IPQ scores)

  It is a widely used multi-factorial pencil-and-paper questionnaire which assesses the five cognitive illness representations on a five-point Likert scale. The IPQ is an 80-item instrument, total scale from 0-10, with higher score indicating higher perception of effects on illness.

  At 6 months

Secondary Outcomes (6)

• Medication Adherence (MARS scores)

  At 6 months

• Summary of Diabetes Self-Care Activities Assessment (SDSCA)

  At 6 months

• International Physical Activity Questionnaire (IPAQ)

  At 6 months

• Center for Epidemiological Studies-Depression (CES-D)

  At 6 months

• Objective adherence with eCAP

  At 7 months

Study Arms (2)

Integrated Intervention

EXPERIMENTAL

4 intervention sessions over 6 months using an educational and counseling intervention developed by the study team.

Behavioral: Integrated Intervention for Breast Cancer Survivors with Diabetes

Control

ACTIVE COMPARATOR

Attention Control group - Supportive counseling for DM management

Behavioral: Attention Control

Interventions

Integrated Intervention for Breast Cancer Survivors with Diabetes BEHAVIORAL

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

Integrated Intervention

Attention Control BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An enrolled participant in the main observational study
• Completed 18-month follow-up interview
• Have at least 1 SMB target (Scored less than scored \<4.5 on the MARS for DM, and/or \<80% on objective adherence at 12-month (DM), and/or scored \<7 on SDSCA)
• Must be willing to participate in the pilot intervention

You may not qualify if:

• \- Participant with suspected clinical depression on CESD (scored ≥20)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Northwestern University Feinberg School of Medicine: collaborator
• Feinstein Institute for Medical Research: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Northwell Health

New Hyde Park, New York, 11040, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Breast Neoplasms

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jenny J. Lin, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant, the outcomes assessor, and the Principal Investigator (Jenny J. Lin) are blinded to study randomization and treatment arm for each participant.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, General Internal Medicine

Model Details: Pilot Overview phase and intervention phase

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 25, 2021
• Study Start: January 27, 2022
• Primary Completion: July 24, 2023
• Study Completion: July 24, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)