Quality of Life Intervention for Young African American Women with Breast Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Survivorship programs

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

Compensation: Varies

Number of Visits: 3

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help young African American women with stage I-III breast cancer manage their daily lives. The treatment, called Y-AMBIENT, is a four-month program featuring educational sessions, materials, and videos, all delivered by phone. It aims to improve participants' quality of life and health outcomes. Suitable candidates are women who identify as African American, are dealing with stage I-III breast cancer, and are currently undergoing chemotherapy or radiation. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance support for others facing similar challenges.

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 seems focused on a quality of life intervention rather than medication changes.

What prior data suggests that the Y-AMBIENT intervention is safe for young African American women with breast cancer?

Research has shown that the Y-AMBIENT program is designed to help young African American women with breast cancer improve their quality of life. This program includes educational sessions, phone calls, and written materials, without involving any medications or medical procedures, so it poses no known safety risks. The main goal is to provide support and information, making it a very low-risk option.

The program offers sessions and follow-up calls to help manage everyday life and concerns related to breast cancer. Since it doesn't involve drugs or invasive treatments, no reports of negative effects have been directly linked to it. Participants typically find this type of support beneficial for their emotional and mental well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Y-AMBIENT because it offers a holistic approach to improving the quality of life for young African American women with breast cancer. Unlike traditional treatments that focus solely on medical care, Y-AMBIENT combines themed educational sessions, written materials, and videos to empower patients with knowledge about their condition. Additionally, personalized follow-up through telephone reinforcement calls helps address ongoing concerns and supports mental well-being, offering a comprehensive care model that enhances emotional and psychological support alongside standard medical treatment. This approach aims to provide a more balanced support system, addressing both physical and emotional aspects of cancer care.

What evidence suggests that the Y-AMBIENT intervention is effective for improving quality of life in young African American women with breast cancer?

Research has shown that Y-AMBIENT, a program designed to improve quality of life, may help young African American women with breast cancer. In this trial, participants in one arm will receive Y-AMBIENT, which includes educational sessions and personalized follow-up calls. Studies have found that support through videos and the internet can enhance quality of life. Women who participated in similar programs reported feeling better emotionally and mentally. This suggests that Y-AMBIENT could be beneficial for young African American women during their cancer journey. ^{6 7 8 9 10}

Who Is on the Research Team?

Timiya Nolan

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for African American women, aged 18-44, who are currently undergoing treatment for stage I-III breast cancer. Participants must speak English and have access to a telephone and the internet. Women already in survivorship programs cannot join as it may affect the study's results.

Inclusion Criteria

I am currently receiving treatment for stage I-III breast cancer.

Self-identify as AA

I was assigned female at birth.

Exclusion Criteria

You've been part of a program that helps cancer survivors, as it could affect the study results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Y-AMBIENT intervention, which includes three themed education sessions, written materials, and videos at month 1, followed by three 20-minute telephone reinforcement calls at months 2, 3, and 4.

4 months

3 in-person sessions, 3 telephone calls

Follow-up

Participants are monitored for health-related outcomes and quality of life improvements after the intervention.

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Y-AMBIENT

Trial Overview The Y-AMBIENT program is being tested to see if it can improve life quality for young African American breast cancer survivors. It's a four-month phone-based intervention with education sessions, follow-ups, written materials, and videos.

How Is the Trial Designed?

Group I: Arm I (Y-AMBIENT) Experimental Treatment 3 Interventions

Patients receive three themed education sessions over 1 hour each, written materials, and videos at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss how they are doing and discuss any concerns that they are still managing at months 2, 3, and 4.

Group II: Arm II (enhanced usual care) Active Control 3 Interventions

Patients receive usual care at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss their chemotherapy regimen at months 2, 3, and 4.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study involving 129 women with breast cancer showed that their health-related quality of life was significantly lower than that of healthy women before rehabilitation, but improved markedly after standardized inpatient rehabilitation, particularly in overall quality of life and physical, emotional, and role functions.

Despite improvements in cognitive and social functions for some patients, only about 50% showed significant changes, indicating that while rehabilitation is beneficial, its effects may vary among individuals and further long-term studies are needed to assess lasting benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Improvement of health-related quality of life in breast cancer patients by inpatient rehabilitation]. Hartmann, U., Ring, C., Reuss-Borst, MA.[2015]

In a study of 544 women who survived breast cancer, those with better future perspectives had a significantly lower risk of mortality within 2 years, highlighting the importance of psychological well-being.

Quality of life (QoL) was assessed through social, psycho-emotional, and physical factors, with social conditions being the most influential, indicating that support systems play a crucial role in the health outcomes of breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life as a predictor of overall survival after breast cancer treatment. De Aguiar, SS., Bergmann, A., Mattos, IE.[2022]

A systematic review of 35 studies, including 30 randomized controlled trials, found that internet-based support interventions can positively impact the quality of life and physical health of breast cancer patients.

However, the effectiveness of these interventions in reducing psychological distress, anxiety, and depression was inconsistent, highlighting the need for more rigorous research to better understand their overall impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based support interventions on patients with breast cancer: a systematic review and narrative synthesis. Huang, Y., Li, Q., Zhou, F., et al.[2022]

Younger women diagnosed with breast cancer experience significantly impaired quality of life (QOL) up to 42 months after diagnosis, with over 70% reporting issues like general aches and dissatisfaction with their appearance.

Factors such as missed workdays, relationship and body image problems, and coping strategies were strongly associated with lower QOL, indicating a need for targeted interventions to address menopausal symptoms and emotional well-being in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life among younger women with breast cancer. Avis, NE., Crawford, S., Manuel, J.[2022]

The telephone interpersonal counseling (TIP-C) intervention significantly reduced depression, fatigue, and stress while increasing positive affect in 48 women with breast cancer over a six-week period.

These preliminary results suggest that TIP-C can effectively improve the quality of life for women with breast cancer, highlighting the importance of social support and counseling services in their treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone interpersonal counseling with women with breast cancer: symptom management and quality of life. Badger, T., Segrin, C., Meek, P., et al.[2015]

A systematic review of 31 randomized controlled trials involving 4651 women with breast cancer found that nurse-led interventions are as safe and effective as physician-led care, particularly in managing symptoms during treatment and survivorship.

Nurse-led teaching, guidance, and case management interventions showed significant benefits in reducing symptom burden, although the effects on health-related quality of life and self-management outcomes were inconsistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer nursing interventions and clinical effectiveness: a systematic review. Chan, RJ., Teleni, L., McDonald, S., et al.[2022]

The My Guide smartphone application was found to be feasible and acceptable for use among Hispanic breast cancer survivors, with a high retention rate of 91.6% and an average usage time of 9.25 hours over 4 weeks.

Participants showed a significant increase in breast cancer knowledge after using the app, although improvements in health-related quality of life (HRQoL) were observed but not statistically significant, indicating potential for further research in a larger trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Smartphone-based pilot intervention for Hispanic breast cancer survivors: a brief report. Buscemi, J., Buitrago, D., Iacobelli, F., et al.[2021]

In a study involving 228 African American women with non-metastatic breast cancer, an interactive video intervention featuring survivor narratives did not significantly improve quality of life (QoL) compared to standard medical care.

Interestingly, longer use of the intervention was linked to increased concerns about cancer recurrence and declines in emotional wellbeing, energy, and physical health role limitations, suggesting that the intervention may have unintended negative effects for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a breast cancer Survivor Stories intervention for African American women. Thompson, T., Pérez, M., Yan, Y., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10910591

Piloting Y-AMBIENT: A Quality of Life Intervention for Young ... We propose to evaluate processes and preliminary outcomes of a targeted QOL intervention vs. attention control in young AA survivors of early (I-II) & late (III) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05452681

Piloting Y-AMBIENT: A Quality of Life Intervention for ... Evaluate feasibility and acceptability of Y-AMBIENT and an attention control among young African American breast cancer survivors. II. Explore the degree to ...

3. withpower.com withpower.com/trial/phase-anatomic-stage-iia-breast-cancer-ajcc-v8-1-2022-69b00

Quality of Life Intervention for Young African American ... Research shows that video-based interventions can improve quality of life for African American breast cancer patients, and internet-based support can reduce ...

4. grantome.com grantome.com/grant/NIH/K08-CA245208-01

A Quality of Life Intervention for Young African American ... African American (AA) women who are young (less than age 45) are more likely to develop breast cancer, report poorer quality of life (QOL), and face negative ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-04131

A Quality of Life Intervention (Y-AMBIENT) for Young ... This clinical trials evaluates the effect of Y-AMBIENT on quality of life in young African American (AA) survivors after treatment for stage I-III breast ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002961025004003

Breast Cancer Trends and Outcomes Among Young Black ... Young Black women have more aggressive breast cancers and worse overall survival than Non-Black young women, though incidence has remained ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40885651/

Breast cancer trends and outcomes among young Black ... Conclusions: Young Black women have more aggressive breast cancers and worse overall survival than Non-Black young women, though incidence has ...

8. bcrf.org bcrf.org/about-breast-cancer/black-women-breast-cancer-disparities/

Black Women and Breast Cancer: Disparities and Research The gap in breast cancer incidence and outcome among Black women is complex and multifactorial. Social, economic, geographic, and lifestyle factors may ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5588632/

Understanding and Effectively Addressing Breast Cancer in ... Black women have higher incidence of breast cancer before the age of 40, more severe disease at all ages, and elevated mortality risk compared to white women.

10. sciencedirect.com sciencedirect.com/science/article/pii/S0160412022000137

Outdoor ambient air pollution and breast cancer survival ... In this study, air pollutants have a harmful impact on breast cancer survival. Additional studies should evaluate potential confounding by socioeconomic ...