Promoting Resilience in Women With Breast Cancer

NCT06133348 | Completed Results

• 2 other identifiers: 3000110282027123
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The PRISM (Promoting Resilience in Stress Management) intervention is an evidence-based program that builds resilience. This program was developed in adolescent and young adult oncology and utilizes centrally administered skills-based coaching to bolster positive psychological tools known as resilience resources. These resources include stress management, goal-setting, and positive reframing. Previous studies using this intervention have found PRISM to be successfully administered remotely and it has improved resilience, psychological distress, hope, and quality of life. Among adult caregivers, PRISM has shown to improve resilience, self-efficacy, and engagement with medical care. While PRISM successfully targets distress and associated downstream consequences known to be experienced by breast cancer survivors, it has not been utilized in adults with cancer or in marginalized communities. Adapting this intervention to this context will require the testing of the intervention and, importantly, tailoring to meet the needs of women with breast cancer, particularly those of marginalized populations who may uniquely benefit from this intervention.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of PRISM

  Feasibility was defined as 70% of participants completing all sessions and pre/post surveys.

  8 months 4 weeks

Secondary Outcomes (33)

• Acceptable, Appropriate, and Feasible

  post-PRISM (ranged from 1 to 7 months after baseline)

• Resilience

  pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)

• Overall Post-Traumatic Growth Inventory

  pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)

• Post-Traumatic Growth Inventory: Personal Strength Sub-scale

  pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)

• Post-Traumatic Growth Inventory: New Possibilities Sub-scale

  pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)

Study Arms (1)

PRISM Intervention

EXPERIMENTAL

This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.

Behavioral: Promoting Resilience in Stress Management Intervention

Interventions

Promoting Resilience in Stress Management Intervention BEHAVIORAL

PRISM is a manualized, brief, skills-based intervention targeting four resilience resources; PRISM is delivered by trained intervention staff (called "coaches" within the PRISM program). Session 1, Stress-Management. Session 2, Goal setting. Session 3, Cognitive Restructuring. Session 4, Meaning-Making. Session 5 (optional), Coming Together. Session 6 (optional) involved advance care planning to discuss.

PRISM Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women undergoing neoadjuvant chemotherapy with early-stage breast cancer, women undergoing treatment for metastatic breast cancer

You may not qualify if:

• patients who do not speak English

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

This pilot has several limitations as this was an initial feasibility study. The sample size was small and collected from a single site, there was not a control comparison, and the outcomes focused on feasibility. Thus, our study was not designed to evaluate efficacy. Additionally, sample heterogeneity could influence participants' psychological experiences while receiving PRISM intervention, and the sample size of this study did not permit sub-group analyses to address these differences.

Results Point of Contact

• Title: Gabrielle Rocque, MD, MSPH
• Organization: University of Alabama at Birmingham Cancer Center

grocque@uabmc.edu

205-996-9281

Study Officials

• Gabrielle Rocque, MD, MSPH

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Division of Hematology & Oncology; Division of Gerontology, Geriatrics, & Palliative Care

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: January 24, 2024
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: November 10, 2025
• Results First Posted: October 14, 2025

Record last verified: 2025-10

Locations

US (1)