No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
120 (estimated)
Sponsor
UNC Lineberger Comprehensive Cancer Center · Other
Who this trial is looking for
This trial is looking for women and men diagnosed with metastatic breast cancer who want to improve their quality of life through a supportive program. Participants will engage in surveys and counseling sessions remotely to help build resilience during their treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with metastatic breast cancer in the last 182 days.
I can understand and respond to surveys in English.
I intend to continue receiving cancer care at the enrolling institution.
I am willing to participate in the study and follow its procedures.
I have given my permission to participate and understand how my health information will be used.
You may not be able to join if
I cannot complete surveys using paper or electronic methods.
I cannot provide my consent to participate.
I cannot read English.
I have stopped all cancer-directed therapy and do not plan to receive it.
I am receiving hospice care or am hospitalized.
I am expected to die within the next 90 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This pilot interventional study evaluates the change from baseline to post-intervention in resilience and other patient-reported outcomes for individuals with a recent diagnosis of metastatic breast cancer (MBC) participating in the Promoting Resilience in Women with Breast Cancer (PRISM) intervention, overall and stratified by race, and to evaluate the feasibility and acceptability of the PRISM i…
This pilot interventional study evaluates the change from baseline to post-intervention in resilience and other patient-reported outcomes for individuals with a recent diagnosis of metastatic breast cancer (MBC) participating in the Promoting Resilience in Women with Breast Cancer (PRISM) intervention, overall and stratified by race, and to evaluate the feasibility and acceptability of the PRISM intervention in the MBC population.
Black women with MBC have shorter survival from the time of metastatic diagnosis to death, compared to White women with clinically similar disease, and may have more rapid declines in quality of life over time. Adverse social determinants of health may play a role in these outcome disparities, due to both social barriers in accessing care, and through direct stress-mediated biological effects on the host and tumor microenvironment. Interventions to reduce stress and optimize resilience during treatment of MBC may improve quality of life and even improve disease outcomes; however, feasibility of face-to-face intervention during intensive medical treatment is limited. Thus, this study aims to demonstrate the feasibility of a remotely delivered resilience intervention, PRISM, already proven effective in other cancer settings, for MBC patients, and to gather preliminary efficacy data for a future randomized trial.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
* Participants are willing and able to comply with study procedures based on the judgement of the investigator.
* Male and female patients of age \…
Inclusion Criteria:
* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
* Participants are willing and able to comply with study procedures based on the judgement of the investigator.
* Male and female patients of age \>18 years.
* Pathologic diagnosis of metastatic breast cancer within 182 days prior to enrollment date.
* Able to answer surveys and participate in counseling sessions in English (the patient's first language is not required to be English).
* Indicate intent to receive ongoing cancer care at the enrolling institution.
Exclusion Criteria:
Individuals meeting any of the following exclusion criteria will be excluded from study participation.
* Patient unwilling or unable to complete surveys via one of the following methods: (a) paper survey completed in clinic or mailed directly to patient's home address, including a pre-addressed, pre-stamped return envelope in the mailed survey packet, or (b) electronic survey links sent via emails or text link on a mobile device, tablet, laptop, or desktop computer.
* Patient unwilling or unable to provide verbal or signed consent to participate.
* Participant cannot read English.
* Patient has permanently discontinued cancer-directed therapy or does not intend to receive any cancer-directed therapy, is receiving home or residential hospice care, is hospitalized, or is described as likely to die within 90 days or actively dying in last provider documentation, at the time of enrollment.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.