Diabetes Care for Breast Cancer Patients

Browse trials for

• Breast Neoplasms 12,544
• Prediabetic State 999
• Diabetes Mellitus, Type 2 9,359

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 74 is close to the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

Study arms

• Experimental
  Nurse-practitioner led intervention group

  A nurse practitioner (NP) who is trained in diabetes on the oncology team will help manage diabetes for breast cancer patients undergoing cancer treatments

  Behavioral: Nurse-practitioner led intervention

• No intervention
  Non-intervention (control) group

  Patient will not have access to the nurse practitioner led intervention.

Interventions

• BehavioralNurse-practitioner led intervention

  * Face-to-face or virtual consultation with NP during chemotherapy infusion with individualized recommendations/medications AND patient education through the Patient Activated Learning System (PALS). * Weekly follow-ups from NP via phone, Zoom, or in-person (patient directed) for 12 weeks/course of chemotherapy.

Primary outcomes

1. Recruitment Success Ratio

   Number of participants recruited divided by the number of participants approached

   Time frame: 2 years

2. Intervention Completion Ratio

   (Intervention only) Number of participants who completed the intervention divided by the number of participants who were enrolled.

   Time frame: 2 years

3. Data Collection Success Ratio

   Number of participants who completed both surveys divided by the number of participants who were enrolled.

   Time frame: 2 years

4. Patient Questionnaire: Self-report of Intervention Feasibility

   Questionnaire: Feasibility of Intervention Measure (4 items) Response Scale: For each item, respondents can choose a value from 1-5. Scales can be created for the measure by averaging responses for all 4 items for the overall score. The average score range is from 1 to 5 with higher scores indicating that the intervention is very feasible, and lower scores (below 3) indicating the intervention is not feasible.

   Time frame: Immediately post-intervention at the week ~12 follow-up

5. Patient Questionnaire: Self-report of Intervention Acceptability

   Questionnaire: Acceptability of Intervention Measure (4 items) Response Scale: For each item, respondents can choose a value from 1-5. Scales can be created for the measure by averaging responses for all 4 items for the overall score. The average score range is from 1 to 5 with higher scores indicating more favorable attitudes toward the intervention and lower scores (below 3) indicating less favorable attitudes.

   Time frame: Immediately post-intervention at the week 12 follow-up

6. Patient Questionnaire: Self-report of Intervention Appropriateness

   Questionnaire: Intervention Appropriateness Measure (4 items) Response Scale: For each item, respondents can choose a value from 1-5. Scales can be created for the measure by averaging responses for all 4 items for the overall score. The average score range is from 1 to 5 with higher scores indicating the intervention suits their needs well and lower scores (below 3) indicating the intervention does not fit their needs well.

   Time frame: Immediately post-intervention at the week 12 follow-up

7. Ratio of Patients Who Had a Summary Document Created for Them at the End of the Intervention

   Number of patients who had a summary document created for them compared to the number of patients who complete the follow-up visit.

   Time frame: 2 years

8. Mean Number of In-person, Virtual or Phone Contacts With the NP Per Participant.

   This will assess the degree to which the intervention was implemented over the course of the study

   Time frame: 2 years

Secondary outcomes

1. Change in Patient Self-report Responses of Diabetes Treatment Satisfaction Questionnaire

   Diabetes Treatment Satisfaction Questionnaire (8 items) DTSQ, score 0-36; higher scores reflecting higher satisfaction

   Time frame: From baseline to week 12 follow-up visit

2. Severity of Patient Self-report Responses of Neuropathy as Measured By the PRO-CTCAE Survey at Follow-up

   PRO-CTCAE: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Neuropathy - PRO-CTCAE (2 items) 0-8 with higher scores representing worse neuropathy

   Time frame: At week 12 follow-up visit

3. Change in Patient Self-report Responses of Diabetes Distress Scale Questionnaire

   Diabetes Distress Scale (17 items) A score of "1" indicates a particular item is not a problem or bother for the patient, whereas "6" represents an item is very concerning for the patient. To score, the patient's responses will be summed and then divided by the number of items in that scale. A mean score of 3 or higher (moderate distress) is considered as a level of distress that is above average. (decrease in score means the item is considered less of a problem/bother)

   Time frame: From baseline to Week 12 follow-up

4. Change in Patient Self-report Responses of the Functional Assessment of Cancer Therapy-Breast Questionnaire

   Functional Assessment of Cancer Therapy -Breast (44-items) measures quality of life for patients with breast cancer. Total scores range from 0-148 with higher scores representing better quality of life.

   Time frame: From baseline to Week 12 follow-up

5. Average Number of Hospitalizations Since Study Enrollment

   The average number of hospitalizations since study enrollment

   Time frame: From baseline to Week ~12 follow-up

6. Average Number of ED Visits Since Study Enrollment

   The average number of emergency department (ED) visits since study enrollment

   Time frame: From baseline to Week ~12 follow-up

7. Average Number of Uncompleted Chemotherapy Sessions

   Average number of planned chemo sessions that were not completed by participants

   Time frame: From baseline to Week ~12 follow-up

8. Proportion of Planned Chemo Session Completed (%)

   The proportion of planned chemo session completed during study enrollment, as a percentage

   Time frame: From baseline to Week ~12 follow-up

9. Chemo Dose Reduction

   Whether or not participants had their chemotherapy dose reduced

   Time frame: From baseline to Week ~12 follow-up

10. Most Recent HbA1c Level

    Average last HbA1c level

    Time frame: From baseline to Week ~12 follow-up

11. Highest Glucose During Treatment

    Average highest glucose measure during treatment

    Time frame: From baseline to Week ~12 follow-up

Baseline characteristics

Publications

• Gearing RE, El-Bassel N, Ghesquiere A, Baldwin S, Gillies J, Ngeow E. Major ingredients of fidelity: a review and scientific guide to improving quality of intervention research implementation. Clin Psychol Rev. 2011 Feb;31(1):79-88. doi: 10.1016/j.cpr.2010.09.007. Epub 2010 Oct 7. PubMed 21130938 ↗
• Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322. PubMed 10474547 ↗

Study documents

• Study protocol · Sep 3, 2024
• Statistical analysis plan · Nov 1, 2022
• Informed consent form · Nov 6, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No