Phone-Based Support Sessions for Breast Cancer

Overseen By Yamile Molina, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Not Latina, Under 30, others

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

Compensation: Varies

Number of Visits: 3

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Latina women at higher risk for breast cancer through phone-based support sessions. The study includes two arms: one provides standard care, while the other offers a support program focused on empowerment and navigation to better manage health risks. Women who identify as Latina, have a genetic or social risk factor for breast cancer (such as family history or financial struggles), and have not received genetic counseling or testing are suitable candidates. Participants will engage in three 30-minute phone sessions over three weeks. As an unphased trial, this study provides a unique opportunity for participants to receive personalized support and potentially enhance their health management skills.

Will I have to stop taking my current medications?

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

What prior data suggests that these phone-based support sessions are safe?

Research has shown that empowerment and navigation programs are generally safe for patients. These programs help individuals manage their healthcare journey more effectively by offering advice on finding resources and making healthcare decisions.

Studies have found that patient navigation can lead to positive outcomes, such as improved healthcare experiences and increased participation in cancer screening. No reports have linked negative effects directly to these support sessions. The main goal is to empower patients and guide them through the healthcare system, without involving medication or medical procedures that could cause physical side effects.

In summary, empowerment and navigation sessions are considered safe, focusing on support and guidance rather than medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the phone-based support sessions for breast cancer because they offer a new approach focused on empowerment and navigation. Unlike traditional treatments that primarily involve surgery, chemotherapy, or radiation, this method emphasizes emotional and logistical support through regular phone calls. This approach is unique because it aims to improve patients' quality of life by providing guidance and emotional strength, potentially enhancing their overall treatment experience and outcomes.

What evidence suggests that this trial's treatments could be effective for breast cancer?

This trial will compare the effectiveness of empowerment and navigation support with standard care for breast cancer patients. Research has shown that programs designed to empower and guide breast cancer patients can be helpful. Studies have found that many survivors feel confident and well-informed about managing their care, with 71.2% feeling confident and 66.4% feeling knowledgeable. Evidence also indicates that patient guidance can lead to better outcomes, such as increasing the number of people who complete screenings by up to 13%. Additionally, these programs improve patients' experiences and their sense of control over their healthcare. Overall, these findings suggest that empowerment and guidance can help patients manage their breast cancer treatment and care more effectively. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for Latina women over 30 years old who have a personal or family history of breast or ovarian cancer and face social challenges affecting their health. They must not have had genetic counseling or testing for cancer, and should be eligible for breast cancer screenings based on guidelines.

Inclusion Criteria

I am a woman, referred by a Latina participant, eligible for breast cancer screenings, and did not attend Session #3.

I am a Latina woman over 30 with a personal or family history of breast/ovarian cancer, have not had genetic counseling or testing, and meet ACS high-risk criteria.

Aim 3: Participant from Aim 1 or participant from Aim 2

Exclusion Criteria

You cannot have participated in Aim 1 or Aim 2 of the study.

Aim 1 and Aim 2: Not meeting at least one of the inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Intervention

Participants engage in three 30-minute, individual, phone-based sessions with the study team across 3 consecutive weeks

3 weeks

3 phone-based sessions

Follow-up

Participants receive monthly check-ins via call/text and complete post-intervention and end-of-study BC survey calls

4 years

Monthly check-ins and survey calls

What Are the Treatments Tested in This Trial?

Interventions

• Empowerment and Navigation

Trial Overview The study tests an empowerment and navigation intervention to help Latinas access breast cancer care. Participants will receive three phone sessions with the study team over consecutive weeks to support them in managing their health risks.

How Is the Trial Designed?

Group I: Arm 2 Experimental Treatment 1 Intervention

Standard of Care (SOC)

Group II: Arm 1 Experimental Treatment 1 Intervention

Empowerment and Navigation

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

Mobile health-based self-management interventions significantly improve self-management behaviors, functional exercise compliance, self-efficacy, and health-related quality of life in breast cancer patients, based on a meta-analysis of 24 studies.

These interventions also reduce the incidence of lymphedema and alleviate anxiety levels, although they do not show significant differences in symptom relief, role functioning, or social support compared to conventional care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile health-based self-management interventions in breast cancer patients: a meta-analysis. Luo, X., Chen, Y., Chen, J., et al.[2022]

A telephone counseling and follow-up program over 8 weeks significantly empowered women with breast cancer undergoing chemotherapy, leading to better adaptation to their diagnosis and treatment.

Participants in the intervention group reported improvements in cancer functional management, breast cancer-specific function, and overall satisfaction with their treatment decisions, as well as reductions in general and specific cancer symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of telephone counseling and follow-up on empowering women with breast cancer undergoing chemotherapy. Nazarpour, S., Mohammadipour, F., Mohammadi, R., et al.[2022]

Women with metastatic breast cancer reported that computer-mediated support groups (CMSGs) offer convenience and a greater sense of control, allowing them to receive support without the immediate emotional impact of physical disability or discussions about dying.

However, the lack of nonverbal cues in CMSGs can hinder the development of intimacy and lead to avoidance of difficult topics, suggesting that structured discussions and facilitators may enhance the effectiveness of these online groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-mediated and face-to-face communication in metastatic cancer support groups. Vilhauer, RP.[2014]

A study involving 60 colorectal cancer patients showed that multidisciplinary collaborative empowerment education significantly reduced psychological distress and improved quality of life during chemotherapy compared to routine health education.

The intervention group experienced notable improvements in both psychological distress and quality of life from baseline, suggesting that this educational approach could enhance health outcomes for patients undergoing chemotherapy, although further research with larger samples is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of multidisciplinary collaborative empowerment education on psychological distress and quality of life in patients with colorectal cancer undergoing chemotherapy. Liu, C., Li, W., Liu, T., et al.[2023]

A qualitative study involving 23 women who continued adjuvant endocrine therapy (AET) and 15 who discontinued, along with 9 healthcare providers, identified key factors that support AET adherence, including preparedness for side effects, strong personal rationale for treatment, and supportive healthcare provider relationships.

Women who discontinued AET often felt overwhelmed by side effects and lacked sufficient information, highlighting the need for better communication and resources to manage side effects and improve adherence to AET.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Both "Vitamin L for Life" and "One Milligram of Satan": A Multi-Perspective Qualitative Exploration of Adjuvant Endocrine Therapy Use after Breast Cancer. Toivonen, KI., Oberoi, D., King-Shier, K., et al.[2021]

The Cancer Empowerment Questionnaire (CEQ) is a validated tool that measures psychological empowerment in cancer survivors, specifically designed for nonmetastatic female breast cancer survivors, with a study involving 140 participants who were an average of 5.5 years post-surgery.

The CEQ identifies four key factors of empowerment, including personal strength and social support, and demonstrates strong reliability and validity, making it a useful measure for assessing patient empowerment in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cancer empowerment questionnaire: psychological empowerment in breast cancer survivors. van den Berg, SW., van Amstel, FK., Ottevanger, PB., et al.[2019]

A survey of 74 women newly diagnosed with breast cancer revealed that while 43% preferred a passive role in treatment decision-making, only 19% were able to engage in a collaborative role, indicating a gap between preference and actual involvement.

Women prioritized personal sources of information, such as healthcare providers and friends, over written materials, highlighting the importance of tailored communication in nursing practice to meet their information needs regarding disease stage, treatment options, and likelihood of cure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information needs, sources of information, and decisional roles in women with breast cancer. Bilodeau, BA., Degner, LF.[2015]

The patient navigation program at a Northern California safety-net hospital significantly improved patients' experiences with breast cancer care, enhancing communication and collaboration between patients and providers, as evidenced by high satisfaction rates among 66 surveyed patients.

Patient navigators played a crucial role in ensuring continuity of care and improving treatment completion rates, although some patients expressed uncertainty about the navigator's role, indicating a need for clearer communication regarding their functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving healthcare empowerment through breast cancer patient navigation: a mixed methods evaluation in a safety-net setting. Gabitova, G., Burke, NJ.[2022]

A systematic review identified 26 effective self-directed digital health tools for cancer patients, but only a small number were successfully disseminated due to barriers like limited funding and infrastructure.

On average, AUD$250,000 was spent on developing tools that were not shared with end-users, highlighting the need for better planning and integration of implementation strategies during the development phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to the availability of efficacious self-directed digital health tools for adults living with cancer and their caregivers: A systematic literature review and author survey study. Bamgboje-Ayodele, A., Smith, A'., Short, CE., et al.[2021]

The Breast Cancer Patient Pathway program, an Internet-based educational initiative, did not significantly improve quality of life, reduce anxiety, or lessen treatment-related side effects in breast cancer patients compared to a control group of 43 patients.

Despite the lack of significant differences, the study highlights the importance of addressing treatment-related side effects and suggests that future patient education programs need to be more effectively designed to enhance patient empowerment and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of an empowering Internet-based Breast Cancer Patient Pathway program on breast cancer patients' clinical outcomes: a randomised controlled trial. Ryhänen, AM., Rankinen, S., Siekkinen, M., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11507469/

The Role of Peer Support and Patient Navigation for ... Under CBO-led cancer control, empowerment was high: most survivors felt confident in (71.2%) and knowledgeable about (66.4%) managing their care.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9561367/

Patient Navigation Can Improve Breast Cancer Outcomes ... Simulation results suggest that network navigation may lead up to a 13% increase in screening completion rate, 7.8% increase in diagnostic ...

3. ascopubs.org ascopubs.org/doi/10.1200/jco.2009.27.15_suppl.6572

Impact of patient navigation on breast cancer outcomes One potential impact of PN program was dramatic increase in proportion of insured patients. Overall survival was not influenced by the PN program. Conclusions: ...

4. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-14-407

Improving healthcare empowerment through breast cancer ... Conclusions. Patient navigation in the Breast Clinic had a positive impact on patients' experiences with care and healthcare empowerment.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2347562525000162

The development and preliminary evaluation of a financial ... This study aims to develop a financial navigation program among patients with breast cancer in China and assess its feasibility, acceptability, and preliminary ...

6. cinj.org cinj.org/study-finds-education-and-navigation-increased-cancer-genetic-counseling-andor-testing

Study Finds Education and Navigation Increased Cancer ... Researchers at Rutgers Cancer Institute of New Jersey explored informing patients of their potentially increased risk for generically-inherited cancers.

7. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21788

Patient navigation across the cancer care continuum: An ... Patient navigation is effective in improving participation in cancer screening and reducing the time from screening to diagnosis and from ...