PRISM Program for Breast Cancer

(PRISMMBC Trial)

Recruiting at 1 trial location

Overseen By Kacee Little

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Hospice care, Hospitalized, Cannot read English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the program Promoting Resilience in Women with Breast Cancer (PRISM) can boost resilience and improve quality of life for individuals recently diagnosed with metastatic breast cancer (MBC), focusing on addressing racial disparities in health outcomes. The study tests whether this support can be effectively delivered remotely, potentially allowing participants to engage without clinic visits. It suits those diagnosed with MBC within the last six months who are continuing their cancer treatment. The goal is to determine if this approach can ease the stress of living with MBC and potentially improve overall health outcomes. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance support for others facing similar challenges.

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 prior data suggests that the PRISM intervention is safe for individuals with metastatic breast cancer?

Previous studies have shown the PRISM program to be safe for participants. This program helps women with metastatic breast cancer build resilience and manage stress. Tested in other cancer settings, it has not been linked to any serious side effects. The goal is to improve quality of life during treatment. So far, patients have received PRISM well, finding it easy to use. No reports of harm or negative effects have been directly attributed to the program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PRISM intervention because it focuses on building psychological resilience in women with metastatic breast cancer (MBC). Unlike traditional treatments that primarily target the cancer itself, such as chemotherapy and hormone therapy, PRISM aims to enhance emotional and mental well-being, which can significantly impact overall quality of life. By promoting resilience, this approach could help women better manage the stress and emotional challenges associated with their diagnosis, potentially improving their overall treatment experience and outcomes.

What evidence suggests that the PRISM intervention is effective for improving resilience in women with metastatic breast cancer?

Research has shown that the PRISM program, which participants in this trial will receive, aids women undergoing cancer treatment by enhancing their resilience and mental well-being. In past studies, PRISM sessions helped participants manage stress more effectively, feel more hopeful, and experience less emotional distress. The program can be completed remotely, providing easy access for those in intensive treatment. While this study focuses on women with advanced breast cancer, earlier use of PRISM in other cancer contexts showed positive results in patients' perceptions of their health. These findings suggest that PRISM could improve the quality of life for women with advanced breast cancer. ^{1 5 6 7 8}

Who Is on the Research Team?

Katie Reeder-Hayes, MD, MBA, MSCR

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

I was diagnosed with metastatic breast cancer in the last 6 months.

Exclusion Criteria

Patient unwilling or unable to provide verbal or signed consent to participate

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

I am not pursuing further cancer treatment and may be in hospice or expected to live less than 90 days.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: PRISM Experimental Treatment 1 Intervention

Participants with metastatic breast cancer (MBC) receive the Promoting Resilience in Women with Breast Cancer (PRISM) intervention.

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

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Most women diagnosed with breast cancer experience low psychological distress and report benefits from their cancer experience, although some may face long-term issues like depression and anxiety.

Effective psychosocial interventions exist to help improve psychological adjustment in breast cancer survivors, and ongoing research is needed to better understand the factors that contribute to positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological Adjustment in Breast Cancer Survivors. Stanton, AL., Bower, JE.[2016]

A study involving 14 clinicians revealed that motivations for reporting serious oncology-associated adverse drug reactions included scientific curiosity and public health concerns, but feedback from pharmaceutical manufacturers was predominantly negative.

The research highlights the need for improved pharmacovigilance mechanisms, such as big data and registries, to enhance the reporting and documentation of adverse drug events, addressing barriers like complacency and indifference among clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions. Bennett, CL., Schooley, B., Taylor, MA., et al.[2020]

In a study of 139 breast cancer patients undergoing chemotherapy, using a mobile app for symptom tracking improved the stabilization of daily functional activity when patients reviewed their data with a physician, compared to those who used the app unsupervised.

Patients using the app reported more adverse events than those using traditional questionnaires, indicating that the app enhances awareness and reporting of chemotherapy side effects, particularly when used in a supervised setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. Egbring, M., Far, E., Roos, M., et al.[2022]

A 50-year-old breast cancer patient experienced significant adverse effects from tamoxifen, including hot flushes, hyperhidrosis, urinary frequency, and depression, which negatively impacted her quality of life.

After 25 days of treatment with traditional Korean herbal medicine and acupuncture, the patient's symptoms improved significantly, indicating that these interventions may help alleviate tamoxifen-induced side effects in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. Seo, J., Lee, D., Jo, HG.[2021]

In a study of 3382 women with hormone receptor-positive breast cancer, those with low personal or clinical social support were more likely to not start or adhere to adjuvant endocrine therapy (AET), highlighting the importance of social support in treatment compliance.

Women with moderate or low personal social support had a significantly higher risk of discontinuing AET or being non-adherent, suggesting that healthcare teams should address these support gaps to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personal and clinical social support and adherence to adjuvant endocrine therapy among hormone receptor-positive breast cancer patients in an integrated health care system. Kroenke, CH., Hershman, DL., Gomez, SL., et al.[2019]

In a study of 225 breast cancer patients, it was found that all participants had at least one actionable pharmacogenetic variant that could inform better prescribing decisions for their medications, potentially improving treatment outcomes.

The research highlights the importance of pre-emptive pharmacogenetic testing, as it could help tailor drug and dose selection to enhance efficacy and reduce adverse events associated with polypharmacy in breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Utility of Pre-Emptive Germline Pharmacogenetics in Breast Cancer. Bernard, PS., Wooderchak-Donahue, W., Wei, M., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The integrated mind-body-spirit self-empowerment program for 51 breast cancer survivors led to statistically significant improvements in distress reduction, perceived quality of life, and overall wellness after participation.

Participants reported large effect sizes on all four measures of health and well-being, indicating that the program effectively helped them find greater meaning and purpose in life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holistic healing for women with breast cancer through a mind, body, and spirit self-empowerment program. Kinney, CK., Rodgers, DM., Nash, KA., et al.[2017]

In a study of 193 breast cancer patients undergoing neoadjuvant chemotherapy, resilience before treatment was found to significantly influence health-related quality of life (HRQOL) after chemotherapy, primarily through its impact on depression levels during treatment.

The results suggest that monitoring and addressing depression in patients with low resilience could be crucial for improving their HRQOL after chemotherapy, highlighting the importance of psychological support during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychiatric symptoms mediate the effect of resilience on health-related quality of life in patients with breast cancer: Longitudinal examination. Lee, S., Jung, S., Jung, S., et al.[2022]

A survey of 163 young breast cancer survivors revealed that 94% found the survivorship care plan (SCP) helpful for managing their treatment and follow-up, indicating its efficacy in supporting their care.

75% of participants were satisfied with the timing of receiving the SCP kit, suggesting that timely access to resources is crucial for enhancing the quality of life for young breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"When I Needed It": Evaluation of the Use and Timing of Sharsheret's Thriving Again Program for Young Breast Cancer Survivors. Rohan, EA., Townsend, JS., Fleischmann, A., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06855654

Promoting Resilience in Women With Breast Cancer ... This pilot interventional study evaluates the change from baseline to post-intervention in resilience and other patient-reported outcomes for individuals ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/579964

Promoting Resilience in Women With Breast Cancer (PRISM This pilot interventional study evaluates the change from baseline to post-intervention in resilience and other patient-reported outcomes ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12209016/

Promoting resilience in stress management (PRISM) for ... Women receiving chemotherapy for stage I–III breast cancer completed six standard PRISM sessions focused on rapport building, stress management, ...

4. ctv.veeva.com ctv.veeva.com/study/promoting-resilience-in-women-with-breast-cancer

Promoting Resilience in Women With Breast Cancer (PRISM) Previous studies using this intervention have found PRISM to be successfully administered remotely and it has improved resilience, psychological distress, hope, ...

5. smartpatients.com smartpatients.com/trials/NCT06855654

Promoting Resilience in Women With Breast Cancer (PRISM This pilot interventional study evaluates the change from baseline to post-intervention in resilience and other patient-reported outcomes for individuals ...

6. trialx.com trialx.com/clinical-trials/listings/324035/promoting-resilience-in-women-with-breast-cancer-prism-mbc/

Promoting Resilience in Women With Breast Cancer (PRISM Interventions to reduce stress and optimize resilience during treatment of MBC may improve quality of life and even improve disease outcomes; ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/48/NCT06133348/Prot_SAP_000.pdf

Promoting Resilience in Women With Breast Cancer Data and Safety Monitoring ... Cohort 2 will include women undergoing treatment for metastatic breast cancer ... and young adults with cancer: Results from the ...

8. cancer.gov cancer.gov/clinicaltrials/NCI-2025-00134

A Skills-based Intervention for Promoting Resilience in ... ... Resilience in Stress Management for Patients with Metastatic Breast Cancer, PRISM-MBC Trial. ... Black women with metastatic breast cancer (MBC) often ...