DiabetesBRIDGESNCT05092477
Integrated Intervention for Breast Cancer Survivors With Diabetes
A study testing Integrated Intervention for Breast Cancer Survivors with Diabetes in people with Diabetes and Breast Cancer, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Diabetes, Breast Cancer
- What is being tested?
- Integrated Intervention for Breast Cancer Survivors with Diabetes
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Jan 2022to 24 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participant with suspected clinical depression on CESD (scored ≥20)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Feinberg School of Medicine
Chicago, Illinois, 60611
Northwell Health
New Hyde Park, New York, 11040
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Disease Beliefs and Cognition: Effect on Diabetes Management in Older Breast Cancer Survivors
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).
Read the 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
- Being tested
- Integrated Intervention for Breast Cancer Survivors with Diabetes, Attention Control
- Keywords
- Breast Cancer, Intervention, Diabetes, Motivational Interviewing, Cognitive Restructuring, Emotional Response Management
- Medical subject headings
- Diabetes Mellitus, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Intervention for Breast Cancer Survivors with DiabetesBehavioural
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.
- Just SMB concern
- SMB + maladaptive belief + emotional response
- SMB + maladaptive belief
- SMB + emotional response
Attention ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Intervention | Experimental | 4 intervention sessions over 6 months using an educational and counseling intervention developed by the study team. Receives: Behavioral: Integrated Intervention for Breast Cancer Survivors with Diabetes |
| Control | Active comparator | Attention Control group - Supportive counseling for DM management Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months
Secondary outcomes (6)
Medication Adherence (MARS scores)
To assess beliefs about diabetes medication adherence, the MARS, a validated measure, will be administered after the pilot study, at 6 months. MARS is a 10-item self-reported instrument. Total scores range from 0 (low likelihood of medication adherence) to 10 (high likelihood), with higher score indicating higher likelihood of medication adherence.
Measured: At 6 months
Summary of Diabetes Self-Care Activities Assessment (SDSCA)
The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking.
SDSCA is a validated, self-reported measure assessing the number of days the recommended diabetes self-care activities are performed over the past 7 days in the areas of general diet, specific diet, exercise, blood-glucose testing, and foot care. Possible scores range from 0 to 7 days.
Measured: At 6 months
International Physical Activity Questionnaire (IPAQ)
The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity, a validated measure, will be administered at the end of the pilot study, at 6 months. The IPAQ results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.
Measured: At 6 months
Center for Epidemiological Studies-Depression (CES-D)
The Center for Epidemiological Studies-Depression (CES-D) is a 20-item measure that asks participants to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. The CES-D also provides cutoff scores (e.g., 16 or greater) that aid in identifying individuals at risk for clinical depression. Full score from 0- 20, with higher score indicating more symptomology.
Measured: At 6 months
Objective adherence with eCAP
The eCAP™ ECM has the regular pharmacy bottle look and feel patients are used to. The important difference is that eCap™ records real-time adherence data, tracking each opening with the date and time.
Measured: At 7 months
Beliefs about Medicines Questionnaire (BMQ scores)
To assess beliefs about medications, the BMQ, a validated measure, will be administered after the pilot study, at 6 months. The BMQ has two components: beliefs about overuse (score range from 3-15) and perceived risk of medicines (score range from 5-25), total scale 8-40, higher score indicates stronger beliefs in the concepts of the scale.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start27 Jan 2022
- Primary completion24 Jul 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot Overview phase and intervention phase
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, Feinstein Institute for Medical Research, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jenny J Lin, Icahn School of Medicine at Mount Sinai
- Investigators
- Jenny J. Lin, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092477
- Sponsor's protocol ID
- GCO 17-00563
- Other IDs
- R01CA214491
- Acronym
- BRIDGES
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This behavioral coaching intervention plans to enroll a small pilot study of 60 participants. The sample size will be small and the data will be mostly qualitative in nature. The data will be release in the aggregate to protect the participants.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Beliefs and Cognition: Effect on Diabetes Management in Older Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05092477
- Acronym / sponsor ID
- BRIDGES / GCO 17-00563
- Conditions
- Diabetes, Breast Cancer
- Keywords
- Breast Cancer, Intervention, Diabetes, Motivational Interviewing, Cognitive Restructuring, Emotional Response Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Northwestern University, Feinstein Institute for Medical Research, National Cancer Institute (NCI)
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot Overview phase and intervention phase
| Arm | Type | Receives |
|---|---|---|
| Integrated Intervention | Experimental | Behavioral: Integrated Intervention for Breast Cancer Survivors with Diabetes4 intervention sessions over 6 months using an educational and counseling intervention developed by the study team. |
| Control | Active comparator | Behavioral: Attention ControlAttention Control group - Supportive counseling for DM management |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Participant with suspected clinical depression on CESD (scored ≥20)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Intervention for Breast Cancer Survivors with DiabetesAll 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 | Behavioural | Integrated Intervention |
| Attention ControlParticipants 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. | Behavioural | Control |
Primary outcome
Illness Perceptions Questionnaire (IPQ scores)
Time frame: At 6 months
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.
6 secondary outcomes
Medication Adherence (MARS scores)
Time frame: At 6 months
Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Time frame: At 6 months
International Physical Activity Questionnaire (IPAQ)
Time frame: At 6 months
Center for Epidemiological Studies-Depression (CES-D)
Time frame: At 6 months
Objective adherence with eCAP
Time frame: At 7 months
Beliefs about Medicines Questionnaire (BMQ scores)
Time frame: At 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No. This behavioral coaching intervention plans to enroll a small pilot study of 60 participants. The sample size will be small and the data will be mostly qualitative in nature. The data will be release in the aggregate to protect the participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny J. Lin, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Intervention for Breast Cancer Survivors with Diabetes in people with Diabetes and Breast Cancer, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illness Perceptions Questionnaire (IPQ scores) (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.