An interventional study of Checklist, MyChart, OpenNotes and Usual Care in Active Breast Cancer Treatment, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-19.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Not applicable, Interventional, and Health services research
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.
Exclusion Criteria:
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.
Other: Checklist, MyChart, OpenNotes
Care as usual with the medical oncologist.
Other: Usual Care
1) Patient-family agenda-setting checklist, 2) Facilitated proxy registration for MyChart, and 3) Education on access to doctor's electronic visit notes.
Routine medical oncology care
Between-group Differences in Patient Complete Illness Understanding at 9-months
Illness understanding was measured by 4 questions regarding knowledge that is considered to be essential to making informed treatment decisions in serious illness, including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease state, and 4.) expectation of duration of life. We summed responses to each item (coded 1 or 0 to reflect the presence or absence of understanding), yielding a score ranging from 0 to 4. Participants with perfect scores reflecting complete illness understanding (4 of 4 correct responses) were compared to all others.
Time frame: 9 months
Between-group Differences in Mean Patient Satisfaction With Cancer Care at 9-months
Outcome was measured with the short-form 10-item version of the Family Satisfaction with Cancer Care (FAMCARE) questionnaire, a validated multi-item instrument that was developed to assess family perspective on cancer care. Respondents are asked to rate 10 items that relate to emotional support, personalization of care, support of decision-making, accessibility, and coordination. Response categories include "very satisfied" (2 points), "satisfied" (1 point), or "not satisfied" (0 points), and the 10-items may be summed to yield a total score (range: 0 to 20) with higher scores reflecting greater satisfaction.
Time frame: 9 months
Between-group Differences in Patient Anxiety at 9-months
Outcome was measured using the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), a well-established 2-item instrument that asks about symptoms of anxiety in a two-week recall period from 0 ("not at all") to 3 ("nearly every day"). Full range is 0-6 with higher scores indicating more anxiety. Symptoms of anxiety refer to a cutpoint of 3+ on the GAD-2.
Time frame: 9 months
Between-group Differences in Care Partner Complete Illness Understanding at 9-months
Illness understanding was measured by 4 questions regarding knowledge that is considered to be essential to making informed treatment decisions in serious illness, including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease state, and 4.) expectation of duration of life. We summed responses to each item (coded 1 or 0 to reflect the presence or absence of understanding), yielding a score ranging from 0 to 4. Participants with perfect scores reflecting complete illness understanding (4 of 4 correct responses) were compared to all others.
Time frame: 9 months
Between-group Differences in Care Partner Satisfaction With Cancer Care at 9-months
Outcome was measured with the short-form 10-item version of the FAMCARE (Family Satisfaction with Cancer Care) questionnaire, a validated multi-item instrument that was developed to assess family perspective on cancer care. Respondents are asked to rate 10 items that relate to emotional support, personalization of care, support of decision-making, accessibility, and coordination. Response categories include "very satisfied" (2 points), "satisfied" (1 point), or "not satisfied" (0 points), and the 10-items may be summed to yield a total score (range: 0 to 20) with higher scores reflecting greater satisfaction.
Time frame: 9 months
Between-group Differences in Care Partner Anxiety at 9-months
Outcome was measured using the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), a well-established 2-item instrument that asks about symptoms of anxiety in a two-week recall period from 0 ("not at all") to 3 ("nearly every day"). Full range is 0-6 with higher scores indicating more anxiety. Symptoms of anxiety refer to a cutpoint of 3+ on the GAD-2.
Time frame: 9 months
Between-group Differences in Patient Quality of Communication at 9-months
Outcome was measured using the Quality of Communication (QC) Scale, a validated 10-item instrument to assess quality of communication between the participant and the medical oncology team. The scale for each item is from 0 ('Worst you can imagine') to 10 ('Best you can imagine'). Full range is 0-100 with higher scores indicating higher perceived quality of communication.
Time frame: 9 months
Between-group Differences in Care Partner Quality of Communication at 9-months
Outcome was measured using the Quality of Communication (QC) Scale, a validated 10-item instrument to assess quality of communication between the participant and the medical oncology team. The scale for each item is from 0 ('Worst you can imagine') to 10 ('Best you can imagine'). Full range is 0-100 with higher scores indicating higher perceived quality of communication.
Time frame: 9 months
Patients of participating clinicians who were in active treatment for early stage or advanced breast cancer were mailed letters describing the study 3 weeks before their next scheduled visit. Patients who did not "opt out" by mail were contacted by research staff to discuss study procedures and administer a screening interview.
| 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 |
| Withdrew: Death | 5 | 10 |
| Withdrew: Withdrawal by subject | 4 | 2 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Milestone | Multicomponent Intervention | Usual Care |
|---|---|---|
| Started | 69 | 63 |
| Care partner baseline interview | 69 | 63 |
| Care partner 3-month interview | 69 | 60 |
| Care partner 9-month interview | 64 | 55 |
| Care partner 12-month interview | 59 | 48 |
| Completed | 59 | 48 |
| Not completed | 10 | 15 |
| Withdrew: Withdrawal by subject | 4 | 3 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Discontinued because patient death | 5 | 11 |
Illness understanding was measured by 4 questions regarding knowledge that is considered to be essential to making informed treatment decisions in serious illness, including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease state, and 4.) expectation of duration of life. We summed responses to each item (coded 1 or 0 to reflect the presence or absence of understanding), yielding a score ranging from 0 to 4. Participants with perfect scores reflecting complete illness understanding (4 of 4 correct responses) were compared to all others.
| Participants | Multicomponent Intervention | Usual Care |
|---|---|---|
| Complete Illness Understanding at 9-Months | 42 | 38 |
| Not Complete Illness Understanding at 9-Months | 21 | 17 |
Outcome was measured with the short-form 10-item version of the Family Satisfaction with Cancer Care (FAMCARE) questionnaire, a validated multi-item instrument that was developed to assess family perspective on cancer care. Respondents are asked to rate 10 items that relate to emotional support, personalization of care, support of decision-making, accessibility, and coordination. Response categories include "very satisfied" (2 points), "satisfied" (1 point), or "not satisfied" (0 points), and the 10-items may be summed to yield a total score (range: 0 to 20) with higher scores reflecting greater satisfaction.
| score on a scale | Multicomponent Intervention | Usual Care |
|---|---|---|
| Between-group Differences in Mean Patient Satisfaction With Cancer Care at 9-months | 16.9 ± 3.9 | 15.4 ± 5.4 |
Outcome was measured using the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), a well-established 2-item instrument that asks about symptoms of anxiety in a two-week recall period from 0 ("not at all") to 3 ("nearly every day"). Full range is 0-6 with higher scores indicating more anxiety. Symptoms of anxiety refer to a cutpoint of 3+ on the GAD-2.
| Participants | Multicomponent Intervention | Usual Care |
|---|---|---|
| Symptoms of Anxiety at 9-Months | 7 | 8 |
| No Symptoms of Anxiety at 9-Months | 56 | 47 |
Illness understanding was measured by 4 questions regarding knowledge that is considered to be essential to making informed treatment decisions in serious illness, including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease state, and 4.) expectation of duration of life. We summed responses to each item (coded 1 or 0 to reflect the presence or absence of understanding), yielding a score ranging from 0 to 4. Participants with perfect scores reflecting complete illness understanding (4 of 4 correct responses) were compared to all others.
| Participants | Multicomponent Intervention | Usual Care |
|---|---|---|
| Complete Illness Understanding at 9-Months | 44 | 39 |
| Not Complete Illness Understanding at 9-Months | 19 | 16 |
Outcome was measured with the short-form 10-item version of the FAMCARE (Family Satisfaction with Cancer Care) questionnaire, a validated multi-item instrument that was developed to assess family perspective on cancer care. Respondents are asked to rate 10 items that relate to emotional support, personalization of care, support of decision-making, accessibility, and coordination. Response categories include "very satisfied" (2 points), "satisfied" (1 point), or "not satisfied" (0 points), and the 10-items may be summed to yield a total score (range: 0 to 20) with higher scores reflecting greater satisfaction.
| score on a scale | Multicomponent Intervention | Usual Care |
|---|---|---|
| Between-group Differences in Care Partner Satisfaction With Cancer Care at 9-months | 15.7 ± 4.4 | 15.4 ± 5.5 |
Outcome was measured using the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), a well-established 2-item instrument that asks about symptoms of anxiety in a two-week recall period from 0 ("not at all") to 3 ("nearly every day"). Full range is 0-6 with higher scores indicating more anxiety. Symptoms of anxiety refer to a cutpoint of 3+ on the GAD-2.
| Participants | Multicomponent Intervention | Usual Care |
|---|---|---|
| Symptoms of Anxiety at 9-Months | 8 | 10 |
| No Symptoms of Anxiety at 9-Months | 55 | 45 |
Outcome was measured using the Quality of Communication (QC) Scale, a validated 10-item instrument to assess quality of communication between the participant and the medical oncology team. The scale for each item is from 0 ('Worst you can imagine') to 10 ('Best you can imagine'). Full range is 0-100 with higher scores indicating higher perceived quality of communication.
| units on a scale | Multicomponent Intervention | Usual Care |
|---|---|---|
| Between-group Differences in Patient Quality of Communication at 9-months | 89.8 ± 11.6 | 88.0 ± 18.7 |
Outcome was measured using the Quality of Communication (QC) Scale, a validated 10-item instrument to assess quality of communication between the participant and the medical oncology team. The scale for each item is from 0 ('Worst you can imagine') to 10 ('Best you can imagine'). Full range is 0-100 with higher scores indicating higher perceived quality of communication.
| units on a scale | Multicomponent Intervention | Usual Care |
|---|---|---|
| Between-group Differences in Care Partner Quality of Communication at 9-months | 90.3 ± 10.3 | 86.2 ± 15.9 |
Care partner registration for shared access to the patient portal was assessed at baseline and nine-months post-enrollment.
| Participants | Multicomponent Intervention | Usual Care |
|---|---|---|
| Care Partner Registered by 9 Months | 49 | 1 |
| Care Partner Did Not Register by 9 Months | 14 | 54 |
Patient portal use was assessed from date and time-stamped interactions reflecting the frequency, timing, and type of patient portal interactions.Use of the patient portal refers to interactions between enrollment and up to 40-weeks post-enrollment.
| Participants | Multicomponent Intervention | Usual Care |
|---|---|---|
| Patient Viewed a Clinical Visit Note by 9-months | 38 | 18 |
| Patient Did Not View a Clinical Visit Note by 9-months | 22 | 32 |
Patient portal use was assessed from date and time-stamped interactions reflecting the frequency, timing, and type of patient portal interactions. Use of the patient portal refers to interactions between enrollment and up to 40-weeks post-enrollment.
| Participants | Multicomponent Intervention | Usual Care |
|---|---|---|
| Care Partner Viewed a Clinical Visit Note by 9-months | 30 | 0 |
| Care Partner Did Not View a Clinical Visit Note by 9-months | 19 | 1 |
Patient portal use was assessed from date and time-stamped interactions reflecting the frequency, timing, and type of patient portal interactions. Use of the patient portal refers to interactions between enrollment and up to 40-weeks post-enrollment.
| Participants | Multicomponent Intervention | Usual Care |
|---|---|---|
| Patient Exchanged a Direct Message by 9-months | 52 | 38 |
| Patient Did Not Exchange a Direct Message by 9-months | 8 | 12 |
Patient portal use was assessed from date and time-stamped interactions reflecting the frequency, timing, and type of patient portal interactions. Use of the patient portal refers to interactions between enrollment and up to 40-weeks post-enrollment.
| Participants | Multicomponent Intervention | Usual Care |
|---|---|---|
| Care Partner Exchanged a Direct Message by 9-months | 3 | 0 |
| Care Partner Did Not Exchange a Direct Message by 9-months | 46 | 1 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Multicomponent Intervention | 5/69 (7.2%) | 0/69 (0%) | 0/69 (0%) |
| Usual Care | 10/63 (15.9%) | 0/63 (0%) | 0/63 (0%) |
Overall Number of Baseline Participants include 69 dyads (one patient, one care partner) in the intervention arm and 63 dyads (one patient, one care partner) in the usual care arm, for a total of 132 dyads in the study. Baseline participant data for patient and care partner is reported here distinctly, where possible.
| Age, Continuous(years) | Multicomponent Intervention | Usual Care | Total |
|---|---|---|---|
| Patient age | 55.1 ± 13.4 | 52.9 ± 14.5 | 54.1 ± 13.9 |
| Care Partner age | 54.0 ± 13.79 | 54.0 ± 13.5 | 54 ± 13.61 |
| Sex: Female, Male(Participants) | Multicomponent Intervention | Usual Care | Total |
|---|---|---|---|
| Patient sex — Female | 68 | 63 | 131 |
| Patient sex — Male | 1 | 0 | 1 |
| Care Partner sex — Female | 28 | 18 | 46 |
| Care Partner sex — Male | 41 | 45 | 86 |
| Ethnicity (NIH/OMB)(Participants) | Multicomponent Intervention | Usual Care | Total |
|---|---|---|---|
| Patient Ethnicity — Hispanic or Latino | 4 | 3 | 7 |
| Patient Ethnicity — Not Hispanic or Latino | 64 | 60 | 124 |
| Patient Ethnicity — Unknown or Not Reported | 1 | 0 | 1 |
| Care Partner Ethnicity — Hispanic or Latino | 2 | 3 | 5 |
| Care Partner Ethnicity — Not Hispanic or Latino | 65 | 60 | 125 |
| Care Partner Ethnicity — Unknown or Not Reported | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Multicomponent Intervention | Usual Care | Total |
|---|---|---|---|
| Patient Race — American Indian or Alaska Native | 0 | 0 | 0 |
| Patient Race — Asian | 1 | 2 | 3 |
| Patient Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Patient Race — Black or African American | 12 | 14 | 26 |
| Patient Race — White | 55 | 44 | 99 |
| Patient Race — More than one race | 1 | 3 | 4 |
| Patient Race — Unknown or Not Reported | 0 | 0 | 0 |
| Care Partner Race — American Indian or Alaska Native | 0 | 0 | 0 |
| Care Partner Race — Asian | 1 | 3 | 4 |
| Care Partner Race — Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Care Partner Race — Black or African American | 11 | 16 | 27 |
| Care Partner Race — White | 55 | 40 | 95 |
| Care Partner Race — More than one race | 0 | 0 | 0 |
| Care Partner Race — Unknown or Not Reported | 2 | 3 | 5 |
| Region of Enrollment(Participants) | Multicomponent Intervention | Usual Care | Total |
|---|---|---|---|
| United States | 69 | 63 | 132 |
| Breast Cancer Disease Stage(Participants) | Multicomponent Intervention | Usual Care | Total |
|---|---|---|---|
| Early Stage Breast Cancer | 35 | 37 | 72 |
| Metastatic Breast Cancer | 34 | 26 | 60 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — This research involves the collection of data and identifying information from approximately 278 diverse study participants including up to 14 medical oncology clinicians, 132 breast cancer patients, and 132 family member or friend companions. The final dataset will include self-reported demographic and health status measures, information from electronic health records, and information about participant experiences. Even though the final dataset will be stripped of identifying information prior to analysis, the study team believes that there remains a possibility of deductive disclosure of subjects. Upon written request from members of the research community, the following resources will be shared: documentation of the process for accessing the study data and constructing the analytic dataset; the codebook for the master analytic dataset; the analytic plan for each study aim; the algorithms used for measurement of outcome variables; surveys and questionnaires.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins