Quality-of-Life Intervention for Young African American Breast Cancer Survivors

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Survivorship programs

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

Compensation: Varies

Number of Visits: 3

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young African American women who have completed treatment for early to late-stage breast cancer improve their quality of life. It will compare a new program called Y-AMBIENT (Quality of Life Intervention), which includes phone sessions on spiritual growth, body changes, and relationships, to a control group that receives a cookbook and social calls. Women eligible for this trial have completed chemotherapy or radiation for stage I-III breast cancer. Participants will access educational materials and support through phone calls and online resources. As an unphased trial, this study offers a unique opportunity to enhance personal well-being and connect with supportive resources.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Y-AMBIENT program aims to improve the quality of life for young African American women who have survived breast cancer. Although specific safety data for this program is not available, it involves phone-based education and support sessions. These sessions focus on spiritual growth, physical changes, and mental health. Since the program does not involve medication or medical procedures, it is likely low-risk and easy to manage. Participants will engage in discussions and receive materials to help them cope with their experiences, making side effects unlikely. However, as with any study, participants should ask questions and understand what involvement entails. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Quality-of-Life (QoL) Intervention for young African American breast cancer survivors because it offers a holistic, culturally sensitive approach to post-treatment wellness. Unlike standard medical treatments that focus primarily on physical recovery, this intervention emphasizes spiritual growth, mental health, and relationship building through themed educational sessions. Additionally, it uses a convenient telephone-based delivery method, allowing for personalized support without the need for travel. The approach is comprehensive, addressing not just physical symptoms but also emotional and spiritual well-being, which is crucial for improving overall quality of life after cancer treatment.

What evidence suggests that this trial's treatments could be effective for improving quality of life in young African American breast cancer survivors?

Research has shown that the Y-AMBIENT program, available to participants in this trial, might enhance the quality of life for young African American women who have survived breast cancer. This program offers sessions on spiritual growth, understanding body changes, and managing anxiety, all crucial for overall well-being. Early findings suggest that such programs can aid in emotional and physical recovery after breast cancer treatment. Participants receive educational materials and videos to support their journey. Although more research is needed, initial results are promising for improving life quality after cancer treatment. ^{1 2 3 4 6}

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 young African American women aged 18-44 who have finished treatment for early to late-stage breast cancer. Participants must speak English and have access to a phone and the internet. Women already in survivorship programs can't join, as it may affect results.

Inclusion Criteria

Are diagnosed with breast cancer stage I-III

Have completed treatment with chemotherapy and/or radiation for stage I-III breast cancer prior to study entry

Are English- speaking

Exclusion Criteria

You have participated in survivorship programs that may have affected your health outcomes, making it difficult to measure the true effect of the study treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive three themed education sessions and follow-up telephone calls over four months

4 months

3 in-person sessions, 3 telephone calls

Follow-up

Participants are monitored for health-related outcomes and acceptability of the intervention

1 month

Long-term Follow-up

Participants' engagement and use of self-management strategies are assessed

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Control Intervention
• QoL Intervention

Trial Overview The study compares a quality-of-life (QoL) intervention with an attention control among survivors post-treatment. It involves assessments, questionnaires, and educational materials designed to improve life after breast cancer treatment.

How Is the Trial Designed?

Group I: Y-AMBIENT Experimental Treatment 3 Interventions

Y-AMBIENT is a four-month, telephone-based intervention that includes three themed education sessions with three follow-up sessions, written materials, and videos. All themed education and follow-up sessions are conducted according to the respective Y-AMBIENT session outlines and audio-recorded. Session 1, titled "My Self, My Soul," covers topics related to spiritual growth and finding meaning in illness. Session 2, titled "My Body," covers topics related to breast changes, aches/pains, fatigue, and weight changes. Session 3, titled "My Mind and My Relationships," covers topics related to anxiety, fear, and relationships with others. The sessions will take approximately one hour, with follow-ups lasting about 20 minutes. Participants will receive both printed and electronic PDF versions of written materials, in addition to video links, to reinforce content delivered during Sessions.

Group II: Attention Control Active Control 3 Interventions

The control condition will consist of receiving a culturally-targeted cookbook applied by an adapted "Food for Thought" cookbook, a guide to grocery shopping smart, and telephone socialization calls. We opted to use the cookbook and guide as conversation pieces given cultural practices associated with food and avert financial constraints with shopping tips. During three, one-hour socialization calls, we will use scripted questions to encourage discussion about the participant, cookbook and guide, and obtain information about survivorship concerns without providing coaching. The follow-up calls will last about 20 minutes.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

TOGETHER-YA is a new e-Health intervention designed specifically for young adult cancer survivors, combining relaxation training, cognitive-behavioral therapy, and health education, developed with input from 22 survivors to ensure relevance and acceptability.

In a pilot trial with 11 participants, TOGETHER-YA met all feasibility and acceptability benchmarks, with 58% recruitment, an average attendance of 6 out of 10 sessions, and 82% retention, indicating strong initial support for the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and initial testing of TOGETHER-YA: an eHealth-delivered and group-based psychosocial intervention for young adult cancer survivors. Oswald, LB., Lyleroehr, M., Gudenkauf, LM., et al.[2023]

A study of 116 young breast cancer survivors (YBCS) revealed that Spanish language proficient (SLP) Latinas had lower educational attainment and income, were more likely to undergo mastectomy, and less likely to receive breast reconstruction compared to their English language proficient (ELP) counterparts and African-American survivors.

Satisfaction with care was significantly linked to patient-provider communication and overall health-related quality of life (HRQOL), with SLP Latinas reporting lower emotional and functional wellbeing, highlighting the need for targeted psychosocial support for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related quality of life and care satisfaction outcomes: Informing psychosocial oncology care among Latina and African-American young breast cancer survivors. Ashing, KT., George, M., Jones, V.[2022]

Young women diagnosed with breast cancer before age 40 reported normal health-related quality of life (HRQOL) at diagnosis, with significant improvements in overall well-being and specific areas such as functional, emotional, and physical well-being over the first year of treatment, as measured by the FACT-B scale.

Participants with anxiety or depression at baseline experienced greater improvements in HRQOL compared to those without, suggesting that emotional factors may play a role in the perceived benefits of treatment during this period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Early Changes in Quality of Life in Young Women With Breast Cancer. Al-Kaylani, HM., Loeffler, BT., Mott, SL., et al.[2022]

A study involving 284 young breast cancer survivors found that social support, parenting concerns, and fertility concerns significantly influence their quality of life (QoL) and satisfaction with life (SwL).

Adaptive reactions positively impacted SwL, while distressing reactions negatively affected both SwL and QoL, highlighting the importance of psychological adjustment in survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Matters Most? Predictors of Quality of Life and Life Satisfaction Among Young Breast Cancer Survivors. Martens, K., Ulrich, GR., Ranby, KW., et al.[2021]

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]

The number of psychosocial intervention trials for adolescents and young adults (AYAs) with cancer has significantly increased from an average of 2 trials per year (2007-2014) to 11 trials per year (2015-2021), indicating growing recognition of the need for supportive care in this population.

Despite this progress, many trials (20.4%) did not assess health-related quality of life (HRQOL), and the measures used varied widely, highlighting the need for more standardized and comprehensive HRQOL assessments that cover all relevant domains, especially those underrepresented like body image and sexuality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of health-related quality of life outcomes in psychosocial intervention trials for adolescent and young adult cancer survivors. Murphy, KM., Siembida, E., Lau, N., et al.[2023]

Younger women (≤50 years) who have completed treatment for breast cancer reported significantly greater disruptions in their quality of life (QOL) compared to older women (>50 years), particularly in emotional well-being and cancer-specific concerns.

Younger women also experienced higher levels of depression and intrusive thoughts related to their disease, indicating a need for targeted psychosocial interventions to support this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Age-related differences in the quality of life of breast carcinoma patients after treatment. Wenzel, LB., Fairclough, DL., Brady, MJ., et al.[2022]

Long-term breast cancer survivors showed significant differences in quality of life (QOL) compared to healthy controls, particularly in fatigue and physical functioning, with 652 survivors and 1,188 controls participating in the study.

However, these differences in QOL decreased over time, with 15-year survivors generally having similar QOL scores to controls, suggesting that support is especially needed in the first 5 to 10 years post-diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term quality of life after breast cancer: a French registry-based controlled study. Klein, D., Mercier, M., Abeilard, E., et al.[2015]

Younger breast cancer survivors (BCS) reported significantly more memory problems compared to healthy controls, with up to 23% experiencing significant cognitive impairment, which may affect their quality of life (QoL).

Despite similar cognitive performance between BCS and healthy controls, BCS experienced greater levels of depression and fatigue, indicating that cognitive impairment is linked to poorer psychological and physical well-being, suggesting that addressing these cognitive concerns could improve QoL outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of cognitive impairment and breast cancer survivorship on quality of life in younger breast cancer survivors. Von Ah, D., Crouch, AD., Monahan, PO., et al.[2022]

This pilot study is testing a remote, peer-led physical activity program for younger breast cancer survivors, aiming to recruit 30 participants and assess its feasibility and impact on quality of life over 3 months.

The intervention focuses on improving key quality of life issues such as body image, sexual function, and fatigue, using technology like Fitbits and video chats to support participants, which could lead to broader dissemination of effective strategies for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Remotely Delivered, Peer-Led Physical Activity Intervention for Younger Breast Cancer Survivors (Pink Body Spirit): Protocol for a Feasibility Study and Mixed Methods Process Evaluation. Weiner, LS., Nagel, S., Su, HI., et al.[2020]

Emotional/informational and tangible social support are significantly associated with improved health-related quality of life (HRQoL) in breast cancer survivors, with positive effects on emotional, social, and functional well-being, as well as overall HRQoL.

The study, which included 545 African American and White women with hormone-receptor-positive breast cancer, found that the benefits of social support were consistent across racial groups, indicating that interventions to enhance support can be broadly applied to all survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between aspects of social support and health-related quality of life domains among African American and White breast cancer survivors. Hurtado-de-Mendoza, A., Gonzales, F., Song, M., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05452681

Piloting Y-AMBIENT: A Quality of Life Intervention for ... The purpose of this two-arm pilot RCT is to evaluate processes and preliminary outcomes of a targeted QOL intervention vs. an attention control among young ...

2. withpower.com withpower.com/trial/phase-anatomic-stage-ii-breast-cancer-ajcc-v8-6-2022-dd09f

Quality-of-Life Intervention for Young African American Breast ... The Y-AMBIENT treatment is unique because it focuses on improving the quality of life for young African American breast cancer survivors, addressing their ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-02286

A Quality of Life Intervention (Y-AMBIENT) for Young ... The Y-AMBIENT intervention may improve quality of life and other health-related outcomes in young African American breast cancer survivors.

4. 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) ...

5. ajpmonline.org ajpmonline.org/article/S0749-3797(15)00526-7/fulltext

Evaluation of a Web-Based Program for African American ... Among women aged <45 years, African Americans have the highest breast cancer incidence rates of any ethnic/racial group and disproportionately higher rates ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9735111/

A remotely delivered, peer-led intervention to improve ... Younger breast cancer survivors (YBCS) consistently report poorer quality of life (QOL) than older survivors. Increasing physical activity ...