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

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 3 11 12}

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

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

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

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

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

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.

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]

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]

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]

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 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]

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 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]

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]

References

1. United States 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. [2022]

2. United States 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. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Distress trajectories at the first year diagnosis of breast cancer in relation to 6 years survivorship. [2022]

4. England 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Psychological Adjustment in Breast Cancer Survivors. [2016]

6. Canada 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. [2021]

9. Netherlands 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. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Potential Utility of Pre-Emptive Germline Pharmacogenetics in Breast Cancer. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Holistic healing for women with breast cancer through a mind, body, and spirit self-empowerment program. [2017]

12. England 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. [2019]