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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00129995 | Other Identifier | JHMIRB | |
| SAC170001 | Other Grant/Funding Number | Susan G. Komen Breast Cancer Foundation |
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| Name | Class |
|---|---|
| Susan G. Komen Breast Cancer Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multicomponent Intervention | Experimental | 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 | Care as usual with the medical oncologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Checklist, MyChart, OpenNotes | Other | 1) Patient-family agenda-setting checklist, 2) Facilitated proxy registration for MyChart, and 3) Education on access to doctor's electronic visit notes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Wolff, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Kimmel Cancer Center - Medical Oncology | Baltimore | Maryland | 21231 | United States | ||
| Johns Hopkins Kimmel Cancer Center at Green Spring Station - Medical Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24417565 | Background | Wolff JL, Roter DL, Barron J, Boyd CM, Leff B, Finucane TE, Gallo JJ, Rabins PV, Roth DL, Gitlin LN. A tool to strengthen the older patient-companion partnership in primary care: results from a pilot study. J Am Geriatr Soc. 2014 Feb;62(2):312-9. doi: 10.1111/jgs.12639. Epub 2014 Jan 13. | |
| 27026614 | Background |
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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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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Multicomponent Intervention | 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. |
| FG001 | Usual Care | Care as usual with the medical oncologist. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patient Participant Flow |
|
| |||||||||||||||||||||||||||||||||
| Care Partner Participant Flow |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Multicomponent Intervention | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months. | Posted | Count of Participants | Participants | 9 months |
|
12 months
Assessed for patients only.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multicomponent Intervention | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Program Manager | Johns Hopkins University | 410-614-7910 | dechava1@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2017 | Jan 27, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D057189 | Checklist |
| D033283 | Patient Access to Records |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Usual Care | Other | Routine medical oncology care |
|
| 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. | 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. | 9 months |
| 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. | 9 months |
| Lutherville |
| Maryland |
| 21093 |
| United States |
| Wolff JL, Berger A, Clarke D, Green JA, Stametz R, Yule C, Darer JD. Patients, care partners, and shared access to the patient portal: online practices at an integrated health system. J Am Med Inform Assoc. 2016 Nov;23(6):1150-1158. doi: 10.1093/jamia/ocw025. Epub 2016 Mar 28. |
| 23027317 | Background | Delbanco T, Walker J, Bell SK, Darer JD, Elmore JG, Farag N, Feldman HJ, Mejilla R, Ngo L, Ralston JD, Ross SE, Trivedi N, Vodicka E, Leveille SG. Inviting patients to read their doctors' notes: a quasi-experimental study and a look ahead. Ann Intern Med. 2012 Oct 2;157(7):461-70. doi: 10.7326/0003-4819-157-7-201210020-00002. |
| 31165374 | Result | Wolff JL, Aufill J, Echavarria D, Heughan JA, Lee KT, Connolly RM, Fetting JH, Jelovac D, Papathakis K, Riley C, Stearns V, Thorner E, Zafman N, Levy HP, Dy SM, Wolff AC. Sharing in care: engaging care partners in the care and communication of breast cancer patients. Breast Cancer Res Treat. 2019 Aug;177(1):127-136. doi: 10.1007/s10549-019-05306-9. Epub 2019 Jun 4. |
| 33579966 | Derived | Wolff JL, Aufill J, Echavarria D, Blackford AL, Connolly RM, Fetting JH, Jelovac D, Papathakis K, Riley C, Stearns V, Zafman N, Thorner E, Levy HP, Guo A, Dy SM, Wolff AC. A randomized intervention involving family to improve communication in breast cancer care. NPJ Breast Cancer. 2021 Feb 12;7(1):14. doi: 10.1038/s41523-021-00217-9. |
| Lost to Follow-up |
|
| Care Partner 3-Month Interview |
|
| Care Partner 9-Month Interview |
|
| Care Partner 12-Month Interview |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Usual Care | Care as usual with the medical oncologist. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Breast Cancer Disease Stage | Count of Participants | Participants |
|
| OG001 | Usual Care | Care as usual with the medical oncologist. |
|
|
|
| Primary | 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. | The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months. | Posted | Mean | Standard Deviation | score on a scale | 9 months |
|
|
|
|
| Primary | 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. | The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months. | Posted | Count of Participants | Participants | 9 months |
|
|
|
|
| Primary | 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. | The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months. | Posted | Count of Participants | Participants | 9 months |
|
|
|
|
| Primary | 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. | The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months. | Posted | Mean | Standard Deviation | score on a scale | 9 months |
|
|
|
|
| Primary | 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. | The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months. | Posted | Count of Participants | Participants | 9 months |
|
|
|
|
| Secondary | 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. | The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months. | Posted | Mean | Standard Deviation | units on a scale | 9 months |
|
|
|
|
| Secondary | 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. | The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months. | Posted | Mean | Standard Deviation | units on a scale | 9 months |
|
|
|
|
| Post-Hoc | Between-group Differences in Care Partner Registration for Shared Access to the Patient Portal at 9-months | Care partner registration for shared access to the patient portal was assessed at baseline and nine-months post-enrollment. | The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months. | Posted | Count of Participants | Participants | 9 months |
|
|
|
|
| Post-Hoc | Between-group Differences in Patient Views of Clinical Visit Notes in the Patient Portal at 9-months | 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. | The analysis sample includes the patients who used a patient portal feature at least once during 9 month follow up period. | Posted | Count of Participants | Participants | 9 months |
|
|
|
|
| Post-Hoc | Between-group Differences in Care Partner Views of Clinical Visit Notes in the Patient Portal at 9-months | 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. | The analysis sample includes the care partners who logged in to the patient portal at least once during 9 month follow up period. | Posted | Count of Participants | Participants | 9 months |
|
|
|
|
| Post-Hoc | Between-group Differences in Patient Exchange of Direct Messages in the Patient Portal at 9-months | 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. | The analysis sample includes the patients who logged in to the patient portal at least once during 9 month follow up period. | Posted | Count of Participants | Participants | 9 months |
|
|
|
|
| Post-Hoc | Between-group Differences in Care Partner Exchange of Direct Messages in the Patient Portal at 9-months | 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. | The analysis sample includes the care partners who logged in to the patient portal at least once during 9 month follow up period. | Posted | Count of Participants | Participants | 9 months |
|
|
|
|
| 5 |
| 69 |
| 0 |
| 69 |
| 0 |
| 69 |
| EG001 | Usual Care | Care as usual with the medical oncologist. | 10 | 63 | 0 | 63 | 0 | 63 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D028701 | Patient Rights |
| D006806 | Human Rights |
| D012926 | Social Control, Formal |
| D004472 | Health Care Economics and Organizations |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|