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

Trial Summary

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 data supports the effectiveness of the treatment Y-AMBIENT for young African American women with breast cancer?

Research shows that video-based interventions can improve quality of life for African American breast cancer patients, and internet-based support can reduce psychological distress and improve social support, which may suggest potential benefits of Y-AMBIENT if it includes similar components. ^{1 2 3 4 5}

How is the Y-AMBIENT treatment different from other treatments for young African American women with breast cancer?

Y-AMBIENT is unique because it focuses on improving the quality of life for young African American women with breast cancer, potentially using internet-based support or video interventions, which are designed to reduce psychological distress and enhance social support, unlike traditional treatments that primarily focus on physical symptoms. ^{2 3 6 7 8}

What is the purpose of this trial?

This clinical trial studies the use of a quality of life intervention called Y-AMBIENT to help young African American with stage I-III breast cancer manage daily life. Y-AMBIENT is a four-month, telephone-based intervention that includes three themed education sessions with three follow-up sessions, written materials, and videos. The Y-AMBIENT intervention may improve quality of life and other health-related outcomes in young African American breast cancer survivors.

Research Team

Timiya Nolan

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Breast cancer nursing interventions and clinical effectiveness: a systematic review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based support interventions on patients with breast cancer: a systematic review and narrative synthesis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a breast cancer Survivor Stories intervention for African American women. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Feasibility of a Smartphone-based pilot intervention for Hispanic breast cancer survivors: a brief report. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Telephone interpersonal counseling with women with breast cancer: symptom management and quality of life. [2015]

6. Germany pubmed.ncbi.nlm.nih.gov

[Improvement of health-related quality of life in breast cancer patients by inpatient rehabilitation]. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Quality of life among younger women with breast cancer. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Quality of life as a predictor of overall survival after breast cancer treatment. [2022]