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Trial Title:
Promoting Resilience in Women with Breast Cancer
NCT ID:
NCT06133348
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Promoting Resilience in Stress Management Intervention
Description:
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.
Arm group label:
PRISM Intervention
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Alabama at Birmingham
Address:
City:
Birmingham
Zip:
35294
Country:
United States
Start date:
January 24, 2024
Completion date:
October 24, 2024
Lead sponsor:
Agency:
University of Alabama at Birmingham
Agency class:
Other
Source:
University of Alabama at Birmingham
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06133348
