Clinical trial NCT05092477: Integrated Intervention for Breast Cancer Survivors With Diabetes
Official title: Disease Beliefs and Cognition: Effect on Diabetes Management in Older Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Breast Cancer
Keywords: Breast Cancer
Intervention
Diabetes
Motivational Interviewing
Cognitive Restructuring
Emotional Response Management
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Northwestern University Feinberg School of Medicine
name: Feinstein Institute for Medical Research
name: National Cancer Institute (NCI)
First posted: 2021-10-25
Enrollment: 59
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot Overview phase and intervention phase
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Illness Perceptions Questionnaire (IPQ scores)
timeFrame: At 6 months
Secondary outcomes:
measure: Medication Adherence (MARS scores)
timeFrame: At 6 months
measure: Summary of Diabetes Self-Care Activities Assessment (SDSCA)
timeFrame: At 6 months
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: At 6 months
measure: Center for Epidemiological Studies-Depression (CES-D)
timeFrame: At 6 months
measure: Objective adherence with eCAP
timeFrame: At 7 months
measure: Beliefs about Medicines Questionnaire (BMQ scores)
timeFrame: At 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Feinberg School of Medicine
state: Illinois
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jenny J. Lin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: