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NCT06133348: PRISM

Promoting Resilience in Women With Breast Cancer

Completed NA Results posted Last updated 10 November 2025
What this trial tests

NA trial testing Promoting Resilience in Stress Management Intervention in Breast Cancer in 43 participants. Completed in 23 October 2024.

Timeline
24 January 2024
Primary endpoint
23 October 2024
23 October 2024

Quick facts

Lead sponsorUniversity of Alabama at Birmingham
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposehealth services research
Enrollment43
Start date24 January 2024
Primary completion23 October 2024
Estimated completion23 October 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Alabama at Birmingham

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of PRISM Primary · 8 months 4 weeks

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

GroupValue95% CI
PRISM Intervention33
PRISM Intervention10
Acceptable, Appropriate, and Feasible Secondary · post-PRISM (ranged from 1 to 7 months after baseline)

Acceptability, appropriateness, and feasibility of the intervention were measured using the Acceptability of Intervention Measure (AIM; scored 1-5), Intervention Appropriateness Measure (IAM; scored 1-5), and Feasibility of Intervention Measure (FIM; scored 1-5). Higher scores indicated better outcomes for each validated survey tool. If means are greater than 4, then the study is considered acceptable, appropriate, and/or feasible.

Acceptability of Intervention Measure (AIM)
GroupValue95% CI
PRISM Intervention4.5± 0.7
Intervention Appropriateness Measure (IAM)
GroupValue95% CI
PRISM Intervention4.5± 0.8
Feasibility of Intervention Measure (FIM)
GroupValue95% CI
PRISM Intervention4.6± 0.5
Resilience Secondary · pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)

Connor-Davidson Resilience scale (CD-RISC; scored 0-40, higher scores indicate greater resilience)

pre-PRISM
GroupValue95% CI
PRISM Intervention28.5± 7.0
post-PRISM
GroupValue95% CI
PRISM Intervention31.8± 5.6
Overall Post-Traumatic Growth Inventory Secondary · pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)

Post-Traumatic Growth Inventory (PTGI; scored 0-105 with factor subscales ranging from 0-10 to 0-35; higher scores indicate more positive transformation). Sub-scores are summed together to receive the overall score.

pre-PRISM
GroupValue95% CI
PRISM Intervention57.4± 28.7
post-PRISM
GroupValue95% CI
PRISM Intervention67.8± 28.6
Post-Traumatic Growth Inventory: Personal Strength Sub-scale Secondary · pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)

Post-Traumatic Growth Inventory (PTGI; scored 0-105; higher scores indicate more positive transformation). The Post-Traumatic Growth Inventory Personal Strength sub-scale is scored from 0-20 with higher scores indicating increased resilience, self-reliance, confidence, humility, etc.

pre-PRISM
GroupValue95% CI
PRISM Intervention10.9± 6.0
post-PRISM
GroupValue95% CI
PRISM Intervention13.2± 6.1
Post-Traumatic Growth Inventory: New Possibilities Sub-scale Secondary · pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)

Post-Traumatic Growth Inventory (PTGI; scored 0-105; higher scores indicate more positive transformation). The Post-Traumatic Growth Inventory New Possibilities sub-scale is scored from 0-25 with higher scores indicating an increase in new interests, perspectives, more adaptability and openness to new opportunities.

pre-PRISM
GroupValue95% CI
PRISM Intervention11± 6.9
post-PRISM
GroupValue95% CI
PRISM Intervention14.5± 7.1
Post-Traumatic Growth Inventory: Improved Relationships Sub-scale Secondary · pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)

Post-Traumatic Growth Inventory (PTGI; scored 0-105; higher scores indicate more positive transformation). The Post-Traumatic Growth Inventory Improved Relationship sub-scale is scored from 0-35 with higher scores indicating an increased sense of belonging, emotional vulnerability, empathy, more supportive, and have an increased ability to form stronger bonds with others.

pre-PRISM
GroupValue95% CI
PRISM Intervention20± 9.9
post-PRISM
GroupValue95% CI
PRISM Intervention22.9± 9.2
Post-Traumatic Growth Inventory: Spiritual Growth Sub-scale Secondary · pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)

Post-Traumatic Growth Inventory (PTGI; scored 0-105; higher scores indicate more positive transformation). The Post-Traumatic Growth Inventory Spiritual Growth sub-scale is scored from 0-10 with higher scores indicating deeper and more meaningful beliefs, life philosophies and faith, more awareness, and a clearer purpose in life.

pre-PRISM
GroupValue95% CI
PRISM Intervention6± 3.7
post-PRISM
GroupValue95% CI
PRISM Intervention6.7± 3.7
Post-Traumatic Growth Inventory: Appreciation for Life Sub-scale Secondary · pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)

Post-Traumatic Growth Inventory (PTGI; scored 0-105; higher scores indicate more positive transformation). The Post-Traumatic Growth Inventory Appreciation for Life sub-scale is scored from 0-15 with higher scores indicating increased gratitude, appreciation for the positive things in life, and clearer sense of priorities.

pre-PRISM
GroupValue95% CI
PRISM Intervention9.5± 4.8
post-PRISM
GroupValue95% CI
PRISM Intervention10.5± 4.7
Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Secondary · pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)

Functional Assessment of Chronic Illness Therapy Spiritual Well-Being tool (FACIT-Sp; scored 0-48 with each factor scored 0-16, higher scores indicate greater spiritual well-being). The overall score is a summation of each sub-score.

pre-PRISM
GroupValue95% CI
PRISM Intervention37.1± 8.2
post-PRISM
GroupValue95% CI
PRISM Intervention40.5± 5.4
Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Meaning Sub-score Secondary · pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)

Functional Assessment of Chronic Illness Therapy Spiritual Well-Being tool (FACIT-Sp; scored 0-48 with higher scores indicate greater spiritual well-being). The Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Meaning sub-scale is scored from 0-16 with one question reverse coded. Item scores for the sub-scale are summed, multiplied by 4, and divided by the number of items answered by the participant. A higher score indicates a greater sense of a meaningful life.

pre-PRISM
GroupValue95% CI
PRISM Intervention13.2± 3
post-PRISM
GroupValue95% CI
PRISM Intervention14.5± 1.7
Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Peace Sub-score Secondary · pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)

Functional Assessment of Chronic Illness Therapy Spiritual Well-Being tool (FACIT-Sp; scored 0-48 with higher scores indicate greater spiritual well-being). The Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Peace sub-scale is scored from 0-16 with one question reverse coded. Item scores for the sub-scale are summed, multiplied by 4, and divided by the number of items answered by the participant. A higher score indicates a greater sense of inner peace or harmony.

pre-PRISM
GroupValue95% CI
PRISM Intervention11± 3.4
post-PRISM
GroupValue95% CI
PRISM Intervention12.5± 2.6

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing