N/A
N=132
Involving Family to Improve Communication in Breast Cancer Care
Active Breast Cancer Treatment
Bottom Line
View on ClinicalTrials.gov: NCT03283553 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Between-group Differences in Patient Complete Illness Understanding at 9-months — 42; 38; 21; 17 Participants — p=0.264
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Checklist, MyChart, OpenNotes (Other); Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Between-group Differences in Patient Complete Illness Understanding at 9-months |
42; 38; 21; 17 | 0.264 |
| PRIMARY Between-group Differences in Mean Patient Satisfaction With Cancer Care at 9-months |
16.9; 15.4 | 0.555 |
| PRIMARY Between-group Differences in Patient Anxiety at 9-months |
7; 8; 56; 47 | 0.619 |
| PRIMARY Between-group Differences in Care Partner Complete Illness Understanding at 9-months |
44; 39; 19; 16 | 0.532 |
| PRIMARY Between-group Differences in Care Partner Satisfaction With Cancer Care at 9-months |
15.7; 15.4 | 0.108 |
| PRIMARY Between-group Differences in Care Partner Anxiety at 9-months |
8; 10; 55; 45 | 0.405 |
| SECONDARY Between-group Differences in Patient Quality of Communication at 9-months |
89.8; 88.0 | 0.412 |
| SECONDARY Between-group Differences in Care Partner Quality of Communication at 9-months |
90.3; 86.2 | 0.872 |
Summary
This study evaluates a multi-component communication intervention in the outpatient setting to strengthen communication among patients being actively treated for breast cancer and their support network of family members and friends. The intervention comprises: 1.) a patient-family agenda-setting checklist completed immediately before a regularly scheduled oncology visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to clinician electronic visit notes. The study team will conduct a two-group randomized trial to examine feasibility of the protocol and to compare quality of communication with oncology providers, understanding of patient's cancer, confidence in managing patient's care and satisfaction with cancer care between patient-companion dyads who are in the intervention group (n=60) and patient-companion dyads who receive usual medical oncology care (n=60).
Eligibility Criteria
Inclusion Criteria
- Medical oncology patient: Established patient of participating medical oncologist greater than 18 years of age, have a diagnosis of early stage or advanced breast cancer, are receiving active systemic therapy (in the form of IV adjuvant systemic therapy if early stage), are English speaking, able to provide informed consent themselves, and identify a family member who they would like to include in their care.
- Care partner: Family member (e.g. spouse, adult child, parent, adult sibling or other relative) or unpaid friend who regularly accompanies patient to medical oncology visits.
- Medical oncology provider: Practicing medical oncology provider at a participating clinic who provides care to patients with breast cancer.
Exclusion Criteria
- Medical oncology patients: Younger than 18 years, pregnant, not being treated for breast cancer, do not attend medical oncology visits with family member or unpaid friend or unwilling for their family member or unpaid friend to be contacted.
- Care partner: Paid non-family member who accompanies patient to visits.
Data sourced from ClinicalTrials.gov (NCT03283553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.