Phone-Based Support Sessions for Breast Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Illinois at Chicago
Disqualifiers: Not Latina, Under 30, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The investigator and study staff will identify, recruit and randomize Latina participants with elevated genetic and Social Determinants of Heath (SDH) risks. Within 1 week of enrollment, all Latina Aim 1 participants in both study arms will engage in three 30-minute, individual, phone-based sessions with the study team across 3 consecutive weeks
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 data supports the effectiveness of the treatment Empowerment and Navigation for breast cancer?
Research shows that phone-based support, like telephone counseling, can empower women with breast cancer, helping them adapt better to their diagnosis and treatment, and reducing cancer symptoms. Additionally, patient navigation, which includes support and education, improves healthcare empowerment, potentially leading to better patient outcomes.
12345How is the treatment Empowerment and Navigation unique for breast cancer?
The treatment Empowerment and Navigation is unique because it involves phone-based support sessions, which provide personalized guidance and emotional support remotely, making it more accessible and convenient compared to traditional in-person therapies.
678910Eligibility Criteria
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
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment1 Intervention
Standard of Care (SOC)
Group II: Arm 1Experimental Treatment1 Intervention
Empowerment and Navigation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of IllinoisChicago, IL
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Who Is Running the Clinical Trial?
University of Illinois at ChicagoLead Sponsor
References
The impact of an empowering Internet-based Breast Cancer Patient Pathway program on breast cancer patients' clinical outcomes: a randomised controlled trial. [2019]To evaluate the effect of the Breast Cancer Patient Pathway program on breast cancer patient's empowerment process.
Improving healthcare empowerment through breast cancer patient navigation: a mixed methods evaluation in a safety-net setting. [2022]Breast cancer mortality rates in the U.S. remain relatively high, particularly among ethnic minorities and low-income populations. Unequal access to quality care, lower follow up rates, and poor treatment adherence contribute to rising disparities among these groups. Healthcare empowerment (HCE) is theorized to improve patient outcomes through collaboration with providers and improving understanding of and compliance with treatment. Patient navigation is a health care organizational intervention that essentially improves healthcare empowerment by providing informational, emotional, and psychosocial support. Patient navigators address barriers to care through multilingual coordination of treatment and incorporation of access to community services, support, and education into the continuum of cancer care.
The effect of telephone counseling and follow-up on empowering women with breast cancer undergoing chemotherapy. [2022]Empowering women with breast cancer leads to better adaptation to diagnosis and treatment, and reduces the symptoms of cancer. The purpose of the researchers is to determine the effect of a telephone counseling and follow-up program on empowerment of women with breast cancer undergoing chemotherapy. We used a non-randomized clinical trial design. Researchers applied the telephone counseling and follow-up to the intervention group for 8 weeks. At the end of study, the intervention group showed improvement in measures of cancer functional management and breast cancer specific function, along with satisfaction with the decision, general symptoms of cancer and specific symptoms of breast cancer.
The cancer empowerment questionnaire: psychological empowerment in breast cancer survivors. [2019]New models of cancer care and survivorship ask for empowered patients. But how do we measure that patients can derive strength from themselves (intrapersonal) and their perceived social support (interpersonal)? The 40-item Cancer Empowerment Questionnaire (CEQ) measures psychological empowerment as an individual outcome measure. The CEQ was validated in 140 nonmetastatic female breast cancer survivors (mean 5.5 years postsurgery). Principal component analysis elicited four factors representing intrapersonal (personal strength) and interpersonal (social support, community, health care) aspects of empowerment. The CEQ provides a reliable (Cronbach's α=0.73-0.94) and valid first attempt to operationalize psychological empowerment in cancer care.
Effect of multidisciplinary collaborative empowerment education on psychological distress and quality of life in patients with colorectal cancer undergoing chemotherapy. [2023]To evaluate the effects of multidisciplinary collaborative empowerment education on psychological distress and quality of life (QoL) in patients with colorectal cancer undergoing chemotherapy.
Effectiveness of mobile health-based self-management interventions in breast cancer patients: a meta-analysis. [2022]To determine the effectiveness of mobile health-based self-management interventions on medical/behavioral, role, and emotional management in breast cancer patients.
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. [2021]This study aimed to examine barriers and facilitators to the dissemination of efficacious self-directed digital health tools for adults affected by cancer, and quantify funding used to develop and evaluate these digital health tools.
Both "Vitamin L for Life" and "One Milligram of Satan": A Multi-Perspective Qualitative Exploration of Adjuvant Endocrine Therapy Use after Breast Cancer. [2021]Adjuvant endocrine therapy (AET) is recommended after hormone receptor-positive breast cancer to reduce risk of recurrence, but adherence is sub-optimal in many women. Behavioral interventions have been ineffective in improving adherence rates to AET. This qualitative descriptive study investigates factors that support women in AET use and suggestions for interventions to improve AET use and management. Interviews with women who persisted with AET (n = 23), women who discontinued AET (n = 15), and healthcare providers (HCPs; oncologists, oncology residents, and pharmacists; n = 9) were conducted, transcribed, and described using thematic analysis. Data collection stopped once saturation occurred (i.e., no new codes or themes emerged during interviews). Two researchers created codes and developed themes in an iterative process; a third researcher verified the representativeness of final themes. This study was approved by the Health Research Ethics Board of Alberta (ID: HREBA.CC-17-0513). Women who persisted described being prepared for side effects and having self-management strategies, strong rationale for AET use, supportive HCPs, and available resources as relevant factors. Women who discontinued described feeling overwhelmed by side effects, information needs, drawbacks of AET, helpful/unhelpful experiences with HCPs, and contextual factors as relevant to their discontinuation. HCPs described health system-related and patient-related barriers, side effect management, and patient-provider interactions as relevant to supporting AET use. The considerable overlap in themes among the three groups suggests broad recognition of salient factors relevant to AET use and that associated strategies to improve use may be acceptable to patients and providers alike. Factors supporting AET use could include the following: education (which may be necessary but insufficient), developing a strong personal rationale for use, being prepared for side effects, having side effect management strategies, reciprocal communication between patients and HCPs, and accessible resources.
Computer-mediated and face-to-face communication in metastatic cancer support groups. [2014]To compare the experiences of women with metastatic breast cancer (MBC) in computer-mediated and face-to-face support groups.
Information needs, sources of information, and decisional roles in women with breast cancer. [2015]To describe preferred and actual roles in treatment decision making among women with newly diagnosed breast cancer, to describe their sources of information, and to identify and prioritize their information needs.