Support Program for Breast Cancer

Not currently recruiting at 590 trial locations

Overseen By Sailaja Kamaraju

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Alliance for Clinical Trials in Oncology

Must be taking: Endocrine therapy

Disqualifiers: Previous cancer, Non-English speakers, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if support, such as text reminders or phone counseling, can help breast cancer patients adhere to their endocrine therapy medication plan. The study includes different groups: some will receive text reminders, others phone counseling, some both, and another group will follow the usual care routine with educational materials. It targets women diagnosed with early-stage, hormone receptor-positive breast cancer who have recently started endocrine therapy. Participants must be comfortable using a smartphone for study-related activities. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial does not specify whether you need to stop taking your current medications. However, it focuses on ensuring you take your prescribed endocrine therapy medication as directed.

What prior data suggests that this support program is safe for breast cancer patients?

Research has shown that text message reminders (TMR) effectively and safely help people manage their health. These reminders assist in handling chronic diseases, with no evidence of harm. Studies have also demonstrated that motivational interviewing (MI) is safe. This method involves conversations that encourage positive changes in health habits. It has been used safely across various health settings, showing improvements without negative effects. The combination of TMR and MI also appears safe, aiming to enhance health by reminding and encouraging patients. No reports of harm have emerged from using both methods together, suggesting these strategies are well-tolerated and safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance adherence to endocrine therapy (ET) for breast cancer patients. Unlike standard care, which typically involves regular clinic visits and provides general educational resources, this trial tests personalized support strategies. Arm I offers daily text reminders and monthly check-ins to keep patients on track with their medication. Arm II adds a human touch with motivational interviewing sessions via phone to help patients set and achieve health goals. Arm III combines both approaches for a comprehensive support system, potentially leading to better medication adherence and improved outcomes for breast cancer survivors.

What evidence suggests that this trial's support program could be effective for improving medication adherence in breast cancer patients?

Research has shown that text message reminders can greatly help patients stick to their healthcare routines. In this trial, participants in Arm I will receive daily text message reminders to take their ET medication, which studies have found to increase adherence. Participants in Arm II will engage in motivational interviewing, a method effective in lowering anxiety and depression while boosting patients' confidence in managing their health. Arm III combines both text reminders and motivational interviewing, potentially further improving medication adherence, as evidence suggests these methods work well together to support treatment plans. ^{3 6 7 8 9}

Who Is on the Research Team?

Katherine E. Reeder-Hayes, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for breast cancer patients who've had surgery or other treatments, except reconstruction. They must have hormone receptor positive, HER2-neu negative cancer and started endocrine therapy within the last 6 months or plan to start within 6 weeks after joining. Participants need a smartphone for study activities.

Inclusion Criteria

Patients must be willing to use a smart phone for study activities

You have high levels of estrogen or progesterone receptors in your body.

You have had cancer other than breast cancer in the last 5 years, except for non-melanoma skin cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive online educational information about ET and are randomized to receive text message reminders, motivational interviewing counseling, or both for up to 9 months

9 months

Monthly virtual interactions

Follow-up

Participants are monitored for ET adherence and overall health for up to 24 months post-randomization

24 months

Every 3-6 months (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Additional Support Program Via Text Messaging and Telephone-Based Counseling

Trial Overview The trial tests if text message reminders and telephone-based counseling can help breast cancer patients take their hormonal therapy medication as prescribed. It compares this additional support program with usual care to see if it improves medication adherence.

How Is the Trial Designed?

Group I: Arm III (TMR + MI) Experimental Treatment 5 Interventions

Patients receive online educational information about ET at the start of their ET medication. Patients also receive text messages as in Arm I and motivational interviewing counseling sessions as in Arm II.

Group II: Arm II (MI) Experimental Treatment 4 Interventions

Patients receive online educational information about ET at the start of their ET medication. Patients also receive a total of 5 motivational interviewing counseling sessions via telephone over 30-90 minutes for up to 9 months. These sessions are designed to support patients while they take their ET medication, develop health goals, and stay on track in achieving those goals.

Group III: Arm I (TMR) Experimental Treatment 4 Interventions

Patients receive online educational information about ET at the start of their ET medication. Patients also receive daily text message reminders to take their ET medication and monthly text messages about how they are doing with taking their ET medication. These text messages continue for 9 months.

Group IV: Arm IV (enhanced usual care) Active Control 4 Interventions

Patients attend usual care clinic visits every 3-6 months and receive online educational information about ET at the start of their ET medication. Patients also receive optional online information about living a healthy life after breast cancer.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A 12-month randomized clinical trial involving 432 rural breast cancer survivors found that two different strategies for delivering educational and support interventions had equivalent outcomes in terms of quality of life and mental health measures.

While both strategies were effective, the Early Education and Support group showed slightly worse mental health scores at 9 months compared to the Support and Delayed Education group, suggesting that timing of support may influence short-term mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telephone-based education and support intervention for Rural Breast Cancer Survivors: a randomized controlled trial comparing two implementation strategies in rural Florida. Meneses, K., Pisu, M., Azuero, A., et al.[2021]

In a study of 101 adult cancer patients undergoing chemotherapy, 83% reported experiencing adverse events, highlighting the common side effects of anticancer drugs.

The research found that 11% of adverse events and a significant portion of medical consultations and hospitalizations were linked to a lack of therapeutic education, emphasizing the need for better patient education on treatment and supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Potential clinical impact of therapeutic education in patients treated with anticancer drugs]. Santucci, R., Aatmani, AE., Lescoute, A., et al.[2017]

A study of 1,627 callers to the Cancer Information and Counseling Line (CICL) revealed that while most initial inquiries were about medical information, a significant 67% of callers ended up receiving psychosocial support or counseling, highlighting the effectiveness of telephone counseling in addressing emotional needs.

The majority of callers were female (77%) and non-Hispanic White (77%), with a notable number being family members or friends of cancer patients, indicating that psychosocial support services are not only beneficial for patients but also for their loved ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone counseling in psychosocial oncology: a report from the Cancer Information and Counseling Line. Marcus, AC., Garrett, KM., Kulchak-Rahm, A., et al.[2019]

The Telephone Counseling Trial for Breast Cancer Survivors aims to improve the quality of life for 400 early-stage breast cancer patients through a structured telephone-based counseling intervention over 12 months, focusing on coping strategies and psychological support.

The study will assess various outcomes, including mood and self-efficacy, at multiple follow-up points (3, 6, 12, and 18 months), potentially establishing a model for future psychosocial interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone counseling of breast cancer patients after treatment: a description of a randomized clinical trial. Marcus, AC., Garrett, KM., Cella, D., et al.[2007]

A randomized controlled trial involving cancer patients receiving outpatient chemotherapy showed that daily text messages with self-care guidelines significantly reduced the overall side effects experienced by patients in the intervention group compared to the control group during the first cycle of treatment.

Patients in the intervention group also reported less nausea during both the first and second cycles of chemotherapy, suggesting that text messaging can be an effective tool for managing side effects in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Text Messaging (SMS) for the Management of Side Effects in Cancer Patients Undergoing Chemotherapy Treatment: a Randomized Controlled Trial. Rico, TM., Dos Santos Machado, K., Fernandes, VP., et al.[2022]

A smartphone self-management program was developed to improve adherence to oral chemotherapy in cancer patients, addressing key issues like forgetfulness, side effects, and lack of knowledge about treatment.

The program includes features like medication reminders and tailored information delivery, primarily through simple text messages, based on feedback from end-users, which may enhance its effectiveness in supporting patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Smartphone Program to Support Adherence to Oral Chemotherapy in People with Cancer. Skrabal Ross, X., Gunn, KM., Patterson, P., et al.[2022]

The Breast Cancer e-Support mobile app is designed to improve self-efficacy, social support, and symptom management for women undergoing chemotherapy, with a study involving 108 participants to assess its effectiveness over 6 months.

This study is the first in China to rigorously evaluate a mobile app intervention for breast cancer patients, aiming to enhance their quality of life and psychological well-being through tailored support and resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mobile application of breast cancer e-support program versus routine Care in the treatment of Chinese women with breast cancer undergoing chemotherapy: study protocol for a randomized controlled trial. Zhu, J., Ebert, L., Liu, X., et al.[2022]

The EMPOWER-SMS COVID-19 program successfully enrolled 62.8% of participants (841 out of 1340) and demonstrated high engagement, with 99.3% of participants finding the SMS messages easy to understand and 84.8% considering them useful for support.

The program was delivered with high fidelity (97.43% of messages sent successfully) and low cost (approximately Aus $15.40 per participant), indicating it could be a sustainable option for supporting breast cancer survivors during challenging times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A National Health and Wellness SMS Text Message Program for Breast Cancer Survivors During COVID-19 (EMPOWER-SMS COVID-19): Mixed Methods Evaluation Using the RE-AIM Framework. Singleton, AC., Raeside, R., Hyun, KK., et al.[2023]

A randomized control trial involving 160 women with breast cancer will assess the effectiveness of a six-month text message support program aimed at improving health self-efficacy and various health outcomes compared to usual care.

The study will evaluate changes in self-efficacy, physical activity, dietary behaviors, mood, and quality of life, providing valuable data for future larger trials to support breast cancer survivors in their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A text message intervention to support women's physical and mental health after breast cancer treatments (EMPOWER-SMS): a randomised controlled trial protocol. Singleton, A., Partridge, SR., Raeside, R., et al.[2020]

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]

In a study involving 75 adult cancer patients, daily text messages aimed at improving adherence to oral anticancer medications showed high acceptability, with 90% of participants satisfied with the intervention.

While the text message intervention led to improved adherence and perceived social support, the differences in symptom severity and interference between the experimental and control groups were not statistically significant, indicating the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proof of Concept of a Mobile Health Short Message Service Text Message Intervention That Promotes Adherence to Oral Anticancer Agent Medications: A Randomized Controlled Trial. Spoelstra, SL., Given, CW., Sikorskii, A., et al.[2023]

A bidirectional text-message application, BETA-Text, was successfully piloted with 100 breast cancer patients, showing high acceptance rates (98% found it easy to use and 96% helpful for medication adherence).

The application revealed that therapy-related adverse effects (AEs) were more common than previously reported in clinical trials, with 72% of patients experiencing hot flashes and 39% reporting severe AEs that required provider intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bidirectional Text Messaging to Monitor Endocrine Therapy Adherence and Patient-Reported Outcomes in Breast Cancer. Mougalian, SS., Epstein, LN., Jhaveri, AP., et al.[2022]

Text messaging (SMS) is a promising tool for enhancing cancer care by improving communication, adherence to treatment, and patient engagement, as it is more convenient and personalized than other methods like email.

Despite the potential benefits, there are currently few successful examples of SMS interventions in cancer care, highlighting a gap in implementation that needs to be addressed for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Messaging in Oncology: A Review of the Landscape. Mougalian, SS., Gross, CP., Hall, EK.[2019]

Citations

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