Integrated Intervention for Breast Cancer Survivors With Diabetes

NCT ID: NCT05092477

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-27
• Study Completion Date: 2023-07-24

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).

Detailed Description

The study team will develop and pilot an educational and counseling intervention to improve SMB among breast cancer survivors with comorbid DM. Development of Counseling Modules to Promote SMB: The study team will use triangulation analysis to integrate, compare, and contrast the quantitative and qualitative data in order to identify modifiable beliefs and emotional reactions that are associated with DM SMB and which could be the target of tailored education and counseling interventions. The study team will develop modules that address survivors' modifiable beliefs, provide coping skills for emotional reactions to illness, and suggest self-management strategies that have been found to be successful among peers. Triangulation analyses will be conducted following the methods outlined by Farmer beginning with sorting findings from qualitative and quantitative interviews, convergence coding and then convergence assessment, completeness assessment, researcher comparison and feedback.

Developing the Counseling and Education Approach: The CSM has been used to develop behavioral interventions for patients with low adherence to chronic disease SMB. It is similar to DiMatteo's evidence-based 3-factor model of strategies (provide correct information, ensure appropriate beliefs, and eliminate tangible barriers) that has been successfully used to improve medication adherence. The study team will develop 3 basic modules addressing determinants of SMB identified in the study team's quantitative and qualitative analyses and that could be integrated into a future comprehensive self-management support intervention: 1) Addressing DM and Breast Cancer Beliefs: The study team will use cognitive restructuring techniques to address misconceptions about breast cancer and DM and medication adherence. For example, some may believe that DM self-management is not important because breast cancer will likely recur and progress quickly. These views can be "reconstructed" by teaching survivors about timeline and consequences of breast cancer vs. DM allowing them to understand the disease timelines relative to each other. Moreover, the study team will clarify the potential impact of poor DM control on breast cancer outcomes. 2) Addressing Emotional Responses: Anxiety and worries will be addressed with normalizing statements (e.g., "Many patients feel that way..." "It is natural to be worried about side-effects..."). For those who report elevated levels of cancer (or DM) worry and distress, the study team will offer relaxation exercises, such as a deep breathing exercise coupled with stress reducing visualizations. 3) Practical Strategies to Instill Routine SMB: Qualitative interviews will elucidate various strategies that survivors have devised to support their SMB. These patient-identified approaches will be collated and explored with participants as potential strategies the participants might employ as well. Particularly for those with cognitive issues, strategies might include using external aids (i.e., texted phone reminders, alarms, pill box organizers, medication schedules, etc.), linking SMB to routine daily tasks, providing family support, etc. The study team will also use strategies to enhance information comprehension and retention by breast cancer survivors with cognitive dysfunction including teach-to-goal, multi-modal communication, and optimized formatting of print materials.

Conditions

Diabetes; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Integrated Intervention

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

Group Type: EXPERIMENTAL

Integrated Intervention for Breast Cancer Survivors with Diabetes

Intervention Type: 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

Control

Attention Control group - Supportive counseling for DM management

Group Type: ACTIVE_COMPARATOR

Attention Control

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University Feinberg School of Medicine

OTHER

Sponsor Role: collaborator

Feinstein Institute for Medical Research

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Jenny J Lin

Professor, General Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jenny J. Lin, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Feinberg School of Medicine

Chicago, Illinois, United States

Northwell Health

New Hyde Park, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

R01CA214491

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 17-00563

Identifier Type: -

Identifier Source: org_study_id