PRISM Program for Breast Cancer
(PRISMMBC Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byKatie Reeder-Hayes, MD, MBA, MSCR
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: UNC Lineberger Comprehensive Cancer Center
Disqualifiers: Hospice care, Hospitalized, Cannot read English, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
678910How 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.
1231112Eligibility 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
+3 more
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
+1 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
The University of AlabamaBirmingham, AL
University of North CarolinaChapel Hill, NC
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Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
PfizerIndustry Sponsor
References
Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial. [2022]This randomized controlled trial assessed the effect of a SMART (Stress Management and Resiliency Training) program among 25 women diagnosed with breast cancer. Resilience, perceived stress, anxiety, and quality of life improved at 12 weeks in the active but not the control arm. A brief training in the SMART program can enhance resilience and quality of life and decrease stress and anxiety.
The effect of a supportive program on coping strategies and stress in women diagnosed with breast cancer: A randomized controlled clinical trial. [2021]To investigate the effect of a supportive program on coping strategies and stress in women with breast cancer.
Distress trajectories at the first year diagnosis of breast cancer in relation to 6 years survivorship. [2022]To explore how initial trajectories of distress experienced during the first year following diagnosis with early-stage breast cancer (ESBC) relate to subsequent long-term(6 years) psychosocial outcomes.
Psychiatric symptoms mediate the effect of resilience on health-related quality of life in patients with breast cancer: Longitudinal examination. [2022]Patients with breast cancer receiving neoadjuvant chemotherapy are at increased risk of poor health-related quality of life (HRQOL). This study examined clinical caseness on depression and anxiety mediate the relationship between resilience and HRQOL in patients with breast cancer.
Psychological Adjustment in Breast Cancer Survivors. [2016]Women living with a diagnosis of breast cancer constitute more than 20 % of the cancer survivor population in the United States. Research on trajectories of psychological adjustment in women recently diagnosed with breast suggests that the largest proportion of women evidences relatively low psychological distress either from the point of diagnosis or after a period of recovery. Substantial heterogeneity exists, however, and some women are at risk for lingering depression, anxiety, fear of cancer recurrence and other long-term psychological effects. Most women diagnosed with breast cancer also report a number of benefits that arise from their experience of cancer. Longitudinal studies have illuminated risk and protective factors for psychological adjustment in breast cancer survivors, which we describe in this chapter. Effective psychosocial interventions, as evidenced in randomized controlled trials, also are available for bolstering breast cancer-related adjustment. We offer directions for research to deepen the understanding of biological, psychological, and social contributors to positive adjustment in the context of breast cancer, as well as suggestions for the development of optimally efficient evidence-based psychosocial interventions for women living with the disease.
A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. [2022]The well-being of breast cancer patients and reporting of adverse events require close monitoring. Mobile apps allow continuous recording of disease- and medication-related symptoms in patients undergoing chemotherapy.
Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions. [2020]Oncology-associated adverse drug/device reactions can be fatal. Some clinicians who treat single patients with severe oncology-associated toxicities have researched case series and published this information. We investigated motivations and experiences of select individuals leading such efforts. Clinicians treating individual patients who developed oncology-associated serious adverse drug events were asked to participate. Inclusion criteria included having index patient information, reporting case series, and being collaborative with investigators from two National Institutes of Health funded pharmacovigilance networks. Thirty-minute interviews addressed investigational motivation, feedback from pharmaceutical manufacturers, FDA personnel, and academic leadership, and recommendations for improving pharmacovigilance. Responses were analyzed using constant comparative methods of qualitative analysis. Overall, 18 clinicians met inclusion criteria and 14 interviewees are included. Primary motivations were scientific curiosity, expressed by six clinicians. A less common theme was public health related (three clinicians). Six clinicians received feedback characterized as supportive from academic leaders, while four clinicians received feedback characterized as negative. Three clinicians reported that following the case series publication they were invited to speak at academic institutions worldwide. Responses from pharmaceutical manufacturers were characterized as negative by 12 clinicians. One clinician's wife called the post-reporting time the "Maalox month," while another clinician reported that the manufacturer collaboratively offered to identify additional cases of the toxicity. Responses from FDA employees were characterized as collaborative for two clinicians, neutral for five clinicians, unresponsive for negative by six clinicians. Three clinicians endorsed developing improved reporting mechanisms for individual physicians, while 11 clinicians endorsed safety activities that should be undertaken by persons other than a motivated clinician who personally treats a patient with a severe adverse drug/device reaction. Our study provides some of the first reports of clinician motivations and experiences with reporting serious or potentially fatal oncology-associated adverse drug or device reactions. Overall, it appears that negative feedback from pharmaceutical manufacturers and mixed feedback from the academic community and/or the FDA were reported. Big data, registries, Data Safety Monitoring Boards, and pharmacogenetic studies may facilitate improved pharmacovigilance efforts for oncology-associated adverse drug reactions. These initiatives overcome concerns related to complacency, indifference, ignorance, and system-level problems as barriers to documenting and reporting adverse drug events- barriers that have been previously reported for clinician reporting of serious adverse drug reactions.
Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. [2021]Adverse events of endocrine therapy reduce the breast cancer patient's quality of life and adversely affect treatment compliance.
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]We evaluated associations between personal and clinical social support and non-adherence to adjuvant endocrine therapy (AET) in a large, Northern California breast cancer (BC) cohort from an integrated healthcare network.
Potential Utility of Pre-Emptive Germline Pharmacogenetics in Breast Cancer. [2021]Patients with breast cancer often receive many drugs to manage the cancer, side effects associated with cancer treatment, and co-morbidities (i.e., polypharmacy). Drug-drug and drug-gene interactions contribute to the risk of adverse events (AEs), which could lead to non-adherence and reduced efficacy. Here we investigated several well-characterized inherited (germline) pharmacogenetic (PGx) targets in 225 patients with breast cancer. All relevant clinical, pharmaceutical, and PGx diplotype data were aggregated into a single unifying informatics platform to enable an exploratory analysis of the cohort and to evaluate pharmacy ordering patterns. Of the drugs recorded, there were 38 for which high levels of evidence for clinical actionability with PGx was available from the US FDA and/or the Clinical Pharmacogenetics Implementation Consortium (CPIC). These data were associated with 10 pharmacogenes: DPYD, CYP2C9, CYP2C19, CYP2D6, CYP3A5, CYP4F2, G6PD, MT-RNR1, SLCO1B1, and VKORC1. All patients were taking at least one of the 38 drugs and had inherited at least one actionable PGx variant that would have informed prescribing decisions if this information had been available pre-emptively. The non-cancer drugs with PGx implications that were common (prescribed to at least one-third of patients) included anti-depressants, anti-infectives, non-steroidal anti-inflammatory drugs, opioids, and proton pump inhibitors. Based on these results, we conclude that pre-emptive PGx testing may benefit patients with breast cancer by informing drug and dose selection to maximize efficacy and minimize AEs.
Holistic healing for women with breast cancer through a mind, body, and spirit self-empowerment program. [2017]This article reports results of an integrated mind-body-spirit self-empowerment program for breast cancer survivors. Fifty-one women at various stages of breast cancer completed a series of eclectic lessons offered in a support group format. The program followed an integrated and cumulative lesson plan that progressively and systematically introduced multiple strategies for creating a balance among mental, emotional, spiritual, and physical health. The program's goals were to enable participants to experience a reduction in distress, improve perceived quality of life, reach a deeper sense of meaning and purpose in life, and experience a greater sense of perceived wellness. Self-assessments were obtained on four well-documented measures relating to both pre- and postprogram participation. Differences in pre- and postscores showed statistically significant improvement and large estimated effect sizes on all four measures. Participants' written comments provide examples of the scope and benefits of the program.
"When I Needed It": Evaluation of the Use and Timing of Sharsheret's Thriving Again Program for Young Breast Cancer Survivors. [2019]Approximately 11% of all new breast cancer cases in the USA occur in women aged 45 years or younger. In 2011, CDC funded seven organizations to develop or enhance programs for young breast cancer survivors (YBCS). This paper analyzed program evaluation data collected by one of these organizations to gain a more nuanced understanding of how recipients used the newly developed program and resources for YBCS. Sharsheret's Thriving Again program was evaluated through a web-based survey of survivorship program participants. The evaluation asked questions about participant demographics, use of the kit's survivorship care plan (SCP), satisfaction with the timing of survivorship kit receipt, and factors related to survivors' use of additional Sharsheret programs. We conducted bivariate analyses of survey responses and calculated chi-square statistics for significance testing. Of the 163 women who responded to the survey, 43% were diagnosed with breast cancer at or before age 45 and 69% were of Jewish descent. The majority of women who used the SCP found it helpful to facilitate cancer treatment (94%), follow-up (85%), or discussions with providers (91%). A total of 75% of women who received the SCP kit while either recently diagnosed or undergoing treatment were satisfied with the timing of receipt. Survey respondents found the Thriving Again program and survivorship kit beneficial and indicated timing preferences for when to receive resources and support. Supporting the self-efficacy of cancer survivors may improve survivors' quality of life and is an important aspect of survivorship programs.