Involving Family to Improve Communication in Breast Cancer Care

NCT03283553 | Completed Results

• 3 other identifiers: J1735IRB00129995SAC170001
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Active Breast Cancer Treatment

Keywords

breast cancer

Outcome Measures

Primary Outcomes (6)

• 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.

  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

Secondary Outcomes (2)

• Between-group Differences in Patient Quality of Communication at 9-months

  9 months

• Between-group Differences in Care Partner Quality of Communication at 9-months

  9 months

Study Arms (2)

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.

Other: Checklist, MyChart, OpenNotes

Usual Care

PLACEBO COMPARATOR

Care as usual with the medical oncologist.

Other: Usual Care

Interventions

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.

Multicomponent Intervention

Usual Care OTHER

Routine medical oncology care

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (2)

Johns Hopkins Kimmel Cancer Center - Medical Oncology

Baltimore, Maryland, 21231, United States

Location

Johns Hopkins Kimmel Cancer Center at Green Spring Station - Medical Oncology

Lutherville, Maryland, 21093, United States

Location

Related Publications (5)

• 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.

  PMID: 24417565 BACKGROUND

• 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.

  PMID: 27026614 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.

  PMID: 23027317 BACKGROUND

• 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.

  PMID: 31165374 RESULT

• 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.

  PMID: 33579966 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Checklist; Patient Access to Records

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Patient Rights; Human Rights; Social Control, Formal; Health Care Economics and Organizations

Results Point of Contact

• Title: Research Program Manager
• Organization: Johns Hopkins University

dechava1@jhu.edu

410-614-7910

Study Officials

• Antonio Wolff, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: September 14, 2017
• Study Start: July 20, 2017
• Primary Completion: July 15, 2019
• Study Completion: November 7, 2019
• Last Updated: March 19, 2021
• Results First Posted: March 19, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)