INSPIRE for Breast Cancer

(INSPIRE Trial)

Not yet recruiting at 2 trial locations
GB
MA
Overseen ByMargaret A Thomas, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how sharing patient-reported outcomes (ePROs) with a multidisciplinary tumor board (MDTB) might influence cancer treatment discussions and decisions. It examines whether using these ePROs affects the healthcare team's workload, the treatments recommended and received, and patients' own health reports. The trial includes different groups: one group shares their ePROs with the MDTB, while others do not. Suitable candidates for this trial are those diagnosed with pancreatic, breast, or gynecologic cancer within the last eight weeks who plan to receive treatment at a participating institution. This trial is part of the INSPIRE (INtegrating Systematic PatIent-Reported Evaluations) initiative. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance cancer care discussions and decisions.

What prior data suggests that the INSPIRE intervention is safe?

Research has shown that the INSPIRE approach, which uses patient feedback to help manage treatment, is generally safe. This method involves gathering information from patients, such as their feelings and preferences, and sharing it with doctors. This process helps doctors make better treatment decisions.

No reports have linked problems or safety issues directly to this process. Since INSPIRE is neither a medication nor a physical treatment, it doesn't carry the same risks. Instead, it aims to enhance communication and decision-making in treatment planning. For those concerned about safety, it's reassuring to know that this approach focuses on improving how care is provided rather than altering the actual treatment itself.12345

Why are researchers excited about this trial?

Researchers are excited about the INSPIRE trial because it focuses on integrating patient-reported outcomes into breast cancer care, potentially transforming how treatment decisions are made. Unlike traditional methods that rely heavily on clinical data, this approach emphasizes the patient's own experience and quality of life. By presenting these patient-reported outcomes to a multidisciplinary tumor board, the INSPIRE intervention aims to personalize and enhance treatment, potentially leading to more patient-centered care strategies that could improve overall satisfaction and outcomes.

What evidence suggests that the INSPIRE intervention is effective for breast cancer?

Research has shown that technology-based tools can help women with breast cancer manage symptoms and improve quality of life. A review of studies found these tools effective. In this trial, the INSPIRE program, tested in Group C, collects and shares patient feedback with medical teams to customize treatments based on individual needs and preferences. Although specific data on INSPIRE's effectiveness for breast cancer is limited, early signs suggest that using patient feedback can enhance treatment choices and increase patient satisfaction.16789

Who Is on the Research Team?

GB

Gabrielle B Rocque, MD

Principal Investigator

The University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with breast, ovarian, pancreatic, uterine, or vaginal cancer who are being discussed in a multidisciplinary tumor board. Specific inclusion and exclusion criteria are not detailed here.

Inclusion Criteria

I am 18 years old or older.
I have been diagnosed with pancreatic, breast, or gynecologic cancer within the last 8 weeks.
Patients with intention to be treated at a participating institution
See 3 more

Exclusion Criteria

I plan to get cancer treatment at a different hospital or clinic.
Patients with inability to speak English or Spanish
My clinician has chosen not to participate in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline Assessment

Participants complete baseline questionnaires about health, daily function, quality of life, and other factors.

2 weeks
1 visit (in-person or virtual)

Intervention

Patient-reported outcomes are integrated into multidisciplinary tumor board discussions for the INSPIRE intervention group.

6 months
Regular tumor board meetings (virtual)

Follow-up

Participants complete follow-up questionnaires at 3 and 6 months to assess outcomes.

6 months
2 follow-up contacts (virtual or phone)

What Are the Treatments Tested in This Trial?

Interventions

  • INSPIRE (INtegrating Systematic PatIent-Reported Evaluations)

Trial Overview

The study tests whether adding electronic patient-reported outcomes (ePROs) to tumor board discussions improves care decisions and communication compared to usual practice. It looks at how this affects treatment choices and patient experiences.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Group C- INSPIRE interventionExperimental Treatment3 Interventions
Group II: Group A- Enhanced Usual CareActive Control1 Intervention
Group III: Group B- Enhanced Clinician AwarenessActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

University of Oklahoma

Collaborator

Trials
484
Recruited
95,900+

University of California, Los Angeles

Collaborator

Trials
1,594
Recruited
10,430,000+

Canopy Cancer Collective, LLC

Collaborator

Citations

Technology-based self-management interventions for women ...

We conducted a systematic review of technology-based self-management interventions for women with breast cancer in six countries.

INtegrating Systematic PatIent-Reported Evaluations in ...

The INSPIRE intervention is the systematic capture and presentation of patient-reported outcomes (geriatric assessment, patient preferences ...

Increasing participation in research - breast cancer (Inspire-BrC)

Methods: We hypothesized that the intervention would increase clinical trial enrollment by 6 percentage points compared to our 2012 enrollment ...

Increasing participation in breast cancer research

The primary outcome measure is the proportion of black patients with breast cancer who agree to participate in a therapeutic clinical trial ...

Breast Cancer Clinical Trials: How They Work & Why ...

Learn how breast cancer clinical trials improve treatment and care. Explore trial types, phases, safety, and how to get involved in a study.

BCRF's Precision Prevention Initiative to Support 8 ...

This content will be used in a randomized clinical trial to test if it is effective for changing young women's beliefs about breast cancer risks ...

Effects of web platform delivery of a physical activity program ...

In a randomized controlled trial, we trained ten peer coaches from cancer care organizations to deliver webMFT or MVPA Tracking to 61 breast cancer survivors.

Breast cancer research: New studies show how post- ...

The third study shows that a telephone-based coaching program can significantly increase physical activity in overweight patients, potentially ...

a randomized controlled trial (RCT) for breast cancer prevention

Results: A total of 289 women completed the study (IG =101; CG =188). Considering the combined behaviors for IG (diet and physical activity), ...