120 Participants Needed

PRISM Program for Breast Cancer

(PRISMMBC Trial)

Recruiting at 1 trial location
EL
KL
Overseen ByKacee Little
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: UNC Lineberger Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinator or your doctor.

What data supports the effectiveness of the PRISM treatment for breast cancer?

Research shows that a similar program, the SMART program, helped women with breast cancer feel less stressed and anxious, and improved their resilience and quality of life after 12 weeks. This suggests that the PRISM treatment might also be effective in helping women with breast cancer.12345

Is the PRISM Program for Breast Cancer safe for humans?

The available research does not provide specific safety data for the PRISM Program for Breast Cancer, but it highlights the importance of monitoring adverse events in breast cancer treatments generally.678910

How does the PRISM treatment for breast cancer differ from other treatments?

The PRISM treatment is unique because it focuses on promoting resilience and managing stress in women with breast cancer, rather than directly targeting the cancer itself. It is similar to other supportive programs that aim to improve quality of life and reduce anxiety through mind-body-spirit approaches, but it specifically emphasizes building resilience.1231112

What is the purpose of this trial?

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.

Research Team

KR

Katie Reeder-Hayes, MD, MBA, MSCR

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

This trial is for men and women over 18 with a recent diagnosis of metastatic breast cancer, who can participate in English surveys and counseling. They must plan to continue treatment at the enrolling institution. It's not for those not seeking active treatment, in hospice care, hospitalized, or likely to pass away within 90 days.

Inclusion Criteria

Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information
I am over 18 years old.
Participants are willing and able to comply with study procedures based on the judgement of the investigator
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Exclusion Criteria

Patient unwilling or unable to provide verbal or signed consent to participate
I am not pursuing further cancer treatment and may be in hospice or expected to live less than 90 days.
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
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Promoting Resilience in Women with Breast Cancer (PRISM) intervention remotely

3 months
Remote sessions

Follow-up

Participants are monitored for resilience score changes and other outcomes

12 months

Treatment Details

Interventions

  • Promoting Resilience in Women with Breast Cancer (PRISM)
Trial Overview The PRISM intervention aims to boost resilience and quality of life in individuals with metastatic breast cancer through remote sessions. The study will assess changes from before to after the program and check if it's practical and well-received by participants.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: PRISMExperimental Treatment1 Intervention
Participants with metastatic breast cancer (MBC) receive the Promoting Resilience in Women with Breast Cancer (PRISM) intervention.

Find a Clinic Near You

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials
377
Recruited
95,900+

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

The SMART (Stress Management and Resiliency Training) program significantly improved resilience, reduced perceived stress and anxiety, and enhanced quality of life in 25 women with breast cancer over a 12-week period, compared to a control group.
The intervention, which included group training sessions and follow-up calls, was found to be feasible and effective, indicating that brief resilience training can be beneficial for breast cancer patients.
Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial.Loprinzi, CE., Prasad, K., Schroeder, DR., et al.[2022]
A randomized controlled trial involving 60 women with breast cancer showed that a supportive program significantly improved problem-oriented coping strategies and reduced stress levels compared to a control group.
The intervention, which included education, relaxation techniques, and stress management over six weekly sessions, effectively enhanced coping mechanisms and emotional well-being in participants.
The effect of a supportive program on coping strategies and stress in women diagnosed with breast cancer: A randomized controlled clinical trial.Samami, E., Elyasi, F., Mousavinasab, SN., et al.[2021]
A study of 285 Chinese women with early-stage breast cancer found that their levels of distress in the first 8 months after surgery significantly predicted their psychosocial outcomes 6 years later.
Women who maintained low distress levels (the resilient group) had the best long-term outcomes, while those with chronic distress experienced greater psychological issues and poorer social adjustment, highlighting the need for early identification and intervention for at-risk patients.
Distress trajectories at the first year diagnosis of breast cancer in relation to 6 years survivorship.Lam, WW., Shing, YT., Bonanno, GA., et al.[2022]

References

Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial. [2022]
The effect of a supportive program on coping strategies and stress in women diagnosed with breast cancer: A randomized controlled clinical trial. [2021]
Distress trajectories at the first year diagnosis of breast cancer in relation to 6 years survivorship. [2022]
Psychiatric symptoms mediate the effect of resilience on health-related quality of life in patients with breast cancer: Longitudinal examination. [2022]
Psychological Adjustment in Breast Cancer Survivors. [2016]
A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. [2022]
Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions. [2020]
Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. [2021]
Personal and clinical social support and adherence to adjuvant endocrine therapy among hormone receptor-positive breast cancer patients in an integrated health care system. [2019]
Potential Utility of Pre-Emptive Germline Pharmacogenetics in Breast Cancer. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Holistic healing for women with breast cancer through a mind, body, and spirit self-empowerment program. [2017]
"When I Needed It": Evaluation of the Use and Timing of Sharsheret's Thriving Again Program for Young Breast Cancer Survivors. [2019]
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