| Registry | NCT03283553 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, health services research |
| Enrollment | 132 (Actual) |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other); collaborators: Susan G. Komen Breast Cancer Foundation |
| Conditions | Active Breast Cancer Treatment |
| Interventions | Checklist, MyChart, OpenNotes, Usual Care (Other) |
| Dates | start 2017-07-20, primary completion 2019-07-15, completion 2019-11-07, first posted 2017-09-14, last updated 2021-03-19 |
| Locations | 2 sites in United States |
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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).
Breast cancer is the most common cancer among survivors in the US. Most patients with breast cancer receive help from family in making complex decisions about treatment, handling logistically demanding care coordination, and managing symptoms and side effects. Although family members (as defined by each patient) play a vital role in cancer care, they are not formally recognized or assessed in care delivery, and their need for information and support is typically unmet. Lack of attention to family in care delivery is an important gap that too often leaves families without adequate information about patient health and treatments. This may prevent families and patients from engaging in open conversations, cause them unnecessary anxiety, and negatively affect the quality of cancer care and delivery.
Communication is particularly important in cancer care, as the optimal course of action is determined through longitudinal discussion of prognosis, treatments, and patient goals, preferences, and concerns. Strategies to improve communication for serious illnesses such as cancer have been developed, but typically target a specific decision, conversation, or setting, most often the inpatient hospital. There is growing agreement that communication among patients, families, and providers should be initiated early and continue throughout the disease trajectory. However, little is known about how to provide both patients and families with access to timely information about patient health and mechanisms to communicate directly with health care providers, as proposed in this study.
The goal of this study is to test a multicomponent intervention to strengthen communication and longitudinal partnerships among women with breast cancer and their family members. Recent work by the study team has demonstrated the feasibility, acceptability, and benefit of intervention components which will be combined into a single model of care. The study team's preliminary studies indicate that clarifying patient and family expectations regarding the role of family and providing family with timely and comprehensive information about patient health (as desired by the patient) leads to more effective family involvement, more frequent patient-family-provider interactions, more patient-centered communication, and greater preparedness to manage care.
This study will evaluate the feasibility of delivering a multicomponent communication intervention in the outpatient setting comprising: 1.) a patient-family agenda-setting checklist completed immediately before a regularly scheduled medical oncology visit with a participating medical oncologist, 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 doctor's electronic visit notes. The study will focus on patients who typically attend medical oncology visits with a family member or trusted friend who are already present and involved in communication. This study will enroll up to 132 patients who are on active treatment for breast cancer, up to 132 family member/friend "companions" and up to 14 medical oncology providers. The study team will compare patients and companions who are in the intervention group (n=60 dyads) with patients and companions who are in the control group and receive usual medical oncology care (n=60 dyads). This study will compare quality of communication with medical oncology providers, understanding of patient's cancer, confidence in managing patient's care, satisfaction with cancer care, and symptoms of anxiety after 3 months, 9 months, and 12 months of follow-up.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Multicomponent Intervention | Experimental | Other: Checklist, MyChart, OpenNotes | 1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the 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 doctor's electronic visit notes. |
| Usual Care | Placebo comparator | Other: Usual Care | Care as usual with the medical oncologist. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 1. 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. 2. 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. 3. Medical oncology provider: Practicing medical oncology provider at a participating clinic who provides care to patients with breast cancer. Exclusion Criteria: 1. 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. 2. Care partner: Paid non-family member who accompanies patient to visits.
| Milestone | Multicomponent Intervention | Usual Care |
|---|---|---|
| Started | 69 | 63 |
| Patient baseline interview | 69 | 62 |
| Patient 3-month interview | 67 | 60 |
| Patient 9-month interview | 63 | 57 |
| Patient 12-month interview | 59 | 50 |
| Completed | 59 | 50 |
| Not completed | 10 | 13 |
Time frame: 12 months
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Multicomponent Intervention | 5/69 (7.2%) | 0/69 (0.0%) | 0/69 (0.0%) |
| Usual Care | 10/63 (15.9%) | 0/63 (0.0%) | 0/63 (0.0%) |
| Facility | City | Country | Status |
|---|---|---|---|
| Johns Hopkins Kimmel Cancer Center - Medical Oncology | Baltimore, Maryland | United States | |
| Johns Hopkins Kimmel Cancer Center at Green Spring Station - Medical Oncology | Lutherville, Maryland | United States |