Metastatic Breast Cancer
Conditions
Keywords
palliative care, communication about care preferences
Brief summary
Many people living with metastatic breast cancer face challenging symptoms and frequent medical visits. At the same time, conversations about personal goals, values, and preferences for care may not always happen as early or as often as patients and families would like. This multi-site study will test the effectiveness of a five-session palliative care program, designed specifically for people with metastatic breast cancer and their caregivers, to strengthen communication with clinicians about what matters most in their care. The study aims to inform how palliative care services can be delivered in a more timely, personalized, and scalable way for people living with advanced cancers who have long disease trajectories, such as metastatic breast cancer.
Detailed description
The diagnosis of metastatic breast cancer can bring many challenges including physical symptoms, treatment side effects, and emotional stress for patients and their families. Palliative care specialists work alongside the oncology team to help patients and families manage symptoms, communicate effectively with their clinicians, and cope with the impact of living with cancer. Research has shown that when palliative care and oncology teams collaborate closely, patients often experience better symptom relief, clearer communication about their goals and preferences, improved quality of life and mood, and a stronger understanding of their illness. Caregivers also report feeling more supported and less distressed. The purpose of this research study is to learn whether a personalized palliative care program for people with metastatic breast cancer and their caregivers, called TARGET-PC, can further improve communication, symptom management, coping skills, and understanding of care. In this study, 400 patients with metastatic breast cancer and their caregivers will be randomly assigned to receive either the TARGET-PC program or enhanced usual care. Enhanced usual care includes an electronic prompt that reminds oncology clinicians to discuss and record each patient's goals and preferences for care. The study will take place at the Massachusetts General Hospital Cancer Center, Penn Abramson Cancer Center, and Duke Cancer Center.
Interventions
OTHERPalliative Care Intervention, TARGET-PC
Palliative care intervention focused on eliciting patients' goals and values to facilitate discussion and documentation of health care preferences.
OTHEREnhanced Usual Care
Oncology clinicians will receive an electronic message to encourage them to discuss and document their patients' health care preferences.
Sponsors
National Cancer Institute (NCI)
Duke University
University of Pennsylvania
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria: * age ≥18 years * diagnosed with metastatic breast cancer * within 8 weeks of the oncology visit at which they were identified as having an eligible Epic EOL Care Index (≥ 15) * functioning independently per an Eastern Cooperative Oncology Group performance status ≤2 * receiving their cancer care at one of the participating institutions * able to complete questionnaires in English or Spanish Patient
Exclusion criteria
* received outpatient palliative care visit within the last six months * enrolled in hospice services * diagnosed with a comorbid condition that impairs their ability to understand study procedures and/or consent for the trial as per the report of the oncology clinician(s) Caregiver Inclusion Criteria: * age ≥18 years * identified by the patient as a family member or friend who is primarily involved in their care * able to complete questionnaires in English or Spanish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Documentation of End-of-Life Care Preferences | From date of randomization until date of death or last follow up assessed up to 60 months | To compare proportions of patients with clinician-documented end-of-life care preferences in the electronic health record by last follow-up time point or date of death between study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospice Utilization | From date of randomization until date of death or last follow up assessed up to 60 months | To compare proportions of patients using hospice services by last follow up time point or death of death between study groups. |
| Hospice Length of Stay | From date of randomization until date of death or last follow up assessed up to 60 months | To compare patients' lengths of stay in hospice between study groups among patients who die during study follow up. |
| Death in the Hospital | From date of randomization until date of death or last follow up assessed up to 60 months | To compare proportions of patients dying in the hospital between study groups among patients who die during study follow up. |
| Patient-reported Communication about End-of-Life Care Preferences | From date of randomization until date of death or last follow up assessed up to 60 months | To compare proportions with patient-reported communication about their end-of-life care preferences between study groups by last follow-up time point or date of death using the Prognosis and Treatment Perceptions Questionnaire (PTPQ). The PTPQ has a single item in which patients indicate whether they have discussed their end-of-life care wishes with their clinicians (scored dichotomously as yes or no). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Coping (Brief COPE) | 24 weeks | To compare caregiver-reported use of approach-oriented and avoidant coping strategies per the Brief-COPE between study groups at 24 weeks. The Brief-COPE approach-oriented subscale scores range from 6-24, and the avoidant subscale scores range from 4-16, with higher scores indicating greater use of each strategy. |
| Patient Quality of Life (Functional Assessment of Cancer Therapy-Breast Scale) | 24 Weeks | To compare patient-reported quality of life per the Functional Assessment of Cancer Therapy-Breast (FACT-B) Scale between study groups at 24 weeks. The FACT-B total scale scores range from 0-148, with higher scores indicating better quality of life. |
| Caregiver After Death Assessment | From date of randomization until three months after the patient's death assessed up to 60 months | To compare caregiver-reported assessment of the patient's end-of-life experiences between study groups among caregivers of patients who die during the study period as measured by three items ranging from 0-10, with higher scores indicating worse quality of end-of-life. |
| Caregiver-reported Communication about the Patient's End-of-Life Care Preferences | From date of randomization until date of death or last follow up assessed up to 60 months | To compare caregiver-reported communication about the patient's end-of-life care preferences between study groups by last follow-up time point or the patient's date of death using the Prognosis and Treatment Perceptions Questionnaire (PTPQ). The PTPQ has a single item in which caregivers indicate whether they have discussed the patient's end-of-life care wishes with their clinicians (scored dichotomously as yes or no). |
| Patient Psychological Distress (Hospital Anxiety and Depression Scale - HADS) | 24 weeks | To compare patient-reported anxiety and depression symptoms per the Hospital Anxiety and Depression Scale (HADS) between study groups at 24 weeks. HADS subscale scores range from 0-21, with higher scores indicating worse distress. |
| Patient Coping (Brief COPE) | 24 weeks | To compare patient-reported use of approach-oriented and avoidant coping strategies per the Brief-COPE between study groups at 24 weeks. The Brief-COPE approach-oriented subscale scores range from 6-24, and the avoidant subscale scores range from 4-16, with higher scores indicating greater use of each strategy. |
| Caregiver Quality of Life (Caregiver Oncology QOL Questionnaire) | 24 Weeks | To compare caregiver-reported quality of life per the Caregiver Oncology Quality-of-Life Questionnaire (CarGOQoL) between study groups at 24 weeks. The CarGOQoL total scale scores range from 0-100, with higher scores indicating better quality of life. |
| Caregiver Psychological Distress (Hospital Anxiety and Depression Scale - HADS) | 24 weeks | To compare caregiver-reported anxiety and depression symptoms per the Hospital Anxiety and Depression Scale (HADS) between study groups at 24 weeks. HADS subscale scores range from 0-21, with higher scores indicating worse distress. |
Countries
United States
Contacts
Primary ContactJennifer Temel, MD
Backup ContactJoseph Greer, PhD
Outcome results
None listed