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Promoting Resilience in Women With Breast Cancer

NCT ID: NCT06133348

Last Updated: 2025-11-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-24

Study Completion Date

2024-10-23

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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PRISM Intervention

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.

Group Type EXPERIMENTAL

Promoting Resilience in Stress Management Intervention

Intervention Type 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.

Interventions

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Promoting Resilience in Stress Management Intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients who do not speak English
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Gabrielle Rocque

Associate Professor of Medicine, Division of Hematology & Oncology; Division of Gerontology, Geriatrics, & Palliative Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gabrielle Rocque, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

The University of Alabama at Birmingham

Locations

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The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2027123

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

300011028

Identifier Type: -

Identifier Source: org_study_id