Structured Behavioral Intervention for Breast Cancer

Overseen By Heather J Tipaldos

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Ductal carcinoma in situ, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

3300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a structured program to help women with breast cancer communicate more effectively with healthcare providers and advocate for themselves during treatment. The researchers aim to determine if these skills can improve health outcomes and reduce disparities in care, particularly for African American and American Indian/Alaska Native women, who often encounter more challenges. Participants will receive educational tools, methods to report symptoms, and regular support from study staff. Women with invasive breast cancer living in 59 counties in North Carolina may be eligible to join. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance communication and advocacy skills for better health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a behavioral intervention to improve communication and self-advocacy in breast cancer care.

What prior data suggests that this structured behavioral intervention is safe for breast cancer patients?

Research shows that structured behavioral programs can be safe and helpful for patients. Similar studies have demonstrated that these programs reduce tiredness and improve the quality of life for patients with advanced breast cancer. They include educational materials and tools for reporting symptoms, which help patients actively participate in their cancer care.

The goal is to improve communication and self-advocacy, enabling patients to speak up and understand their treatment better. No reports of harmful side effects have emerged from these programs, so they are considered safe. This personalized and supportive approach aims to enhance the overall experience of cancer care without adding extra risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Structured Behavioral Intervention for breast cancer because it focuses on improving the mental and emotional well-being of patients, which is often overlooked in traditional treatments like surgery, chemotherapy, and radiation. Unlike these conventional methods that directly target the cancer cells, this intervention aims to empower patients with skills and strategies to better cope with their diagnosis and treatment journey. By addressing psychological and behavioral aspects, it may enhance overall quality of life and potentially improve treatment outcomes by boosting adherence to medical treatments and reducing stress.

What evidence suggests that this structured behavioral intervention is effective for improving breast cancer care?

Research has shown that certain structured activities can improve well-being in breast cancer patients. For example, one study found that therapy through a smartphone app reduced anxiety about cancer recurrence in young survivors. Mental preparation before surgery, known as "prehabilitation," has also improved quality of life and mental health. Additionally, mindfulness-based therapy has enhanced overall well-being in breast cancer patients. These findings suggest that structured activities, such as the Structured Behavioral Intervention under study in this trial, could enhance communication and self-advocacy, potentially reducing disparities in breast cancer care. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with breast cancer, focusing on those who may face disparities in care, such as African American and American Indian/Alaska Native women. Participants should be interested in improving communication with healthcare providers and self-advocacy.

Inclusion Criteria

I am a woman with breast cancer living in one of the specified 59 counties in North Carolina.

Exclusion Criteria

I have DCIS or I don't live in the specified area of North Carolina.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Interview and Sample Collection

Participants complete a structured, in-person baseline interview covering breast cancer risk factors, quality of life, comorbidities, and initial treatment. Blood and/or saliva samples are collected.

1-2 weeks

1 visit (in-person)

Behavioral Intervention

Participants receive a structured behavioral intervention designed to improve communication with providers and self-advocacy during cancer care. This includes educational resources, symptom reporting tools, reflective self-assessments, and regular engagement with trained study staff.

19 months

Regular engagement (in-person and virtual)

Follow-up

Participants are monitored for changes in self-advocacy, quality of life, tumor recurrence, and incidence of second primary tumors. Mortality data is also collected.

15 years

Every 12-24 months

What Are the Treatments Tested in This Trial?

Interventions

• Structured Behavioral Intervention

Trial Overview The study tests a structured behavioral intervention aimed at enhancing health communication and self-advocacy among breast cancer patients. It provides educational resources, symptom reporting tools, reflective assessments, and regular contact with trained staff.

How Is the Trial Designed?

Group I: Newly diagnosed with breast cancer Experimental Treatment 1 Intervention

Participants with newly diagnosed with breast cancer live in 59 North Carolina counties.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+

Susan G. Komen Breast Cancer Foundation

Collaborator

Trials

68

Recruited

220,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12306052/

Comparing the effectiveness of gratitude intervention and ... This study aimed to investigate the effects of gratitude and behavioral activation (BA) on anxiety and depression among women with breast cancer ...

2. nature.com nature.com/articles/s41598-025-22889-0

Testing two digital stress-management interventions in a ... Progress in diagnostics and treatment have raised the 5-year relative survival rate for early detected breast cancer to above 90% in many ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.22.00699

Smartphone Psychotherapy Reduces Fear of Cancer ... Our findings showed that smartphone-based PST and BA contributed to reducing FCR among young breast cancer survivors. ... Further tasks include ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0960977617307750

Psychosocial interventions in breast cancer survivorship care A recent systematic review suggests that psychological “prehabilitation” interventions before surgery can improve psychological outcomes, quality of life, and ...

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1488586/full

The efficacy of internet-based cognitive behavior therapy ... A study showed that mindfulness-based cognitive therapy improved the well-being of patients with BC, encompassing their psychological, physical, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11485212/

Supervised, structured and individualized exercise in ... These results demonstrate that supervised exercise has positive effects on physical fatigue and HRQOL in patients with MBC and should be ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07214610

Integrating Biological, Clinical, and Behavioral Factors to ... All participants will be prospectively assigned to a structured behavioral intervention embedded within the research process. The goal of the ...

8. nature.com nature.com/articles/s41591-024-03143-y

Supervised, structured and individualized exercise in ... These results demonstrate that supervised exercise has positive effects on physical fatigue and HRQOL in patients with MBC and should be recommended as part of ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2949820124000456

Transforming breast cancer management with real-world ... These structured data are then used to analyze treatment outcomes across different patient demographics, helping to identify patterns and improve clinical ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4516670/

Brief Cognitive-Behavioral and Relaxation Training ... A Randomized trial of a cognitive-behavioral therapy and hypnosis intervention on positive and negative affect during breast cancer radiotherapy. J Clin ...