Support Program for Breast Cancer

Recruiting at 491 trial locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Alliance for Clinical Trials in Oncology

Must be taking: Endocrine therapy

Disqualifiers: Previous cancer, Non-English speakers, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase III trial compares an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast cancer patients take their endocrine therapy medication as prescribed (medication adherence). Medication adherence is how well patients take the medication as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a serious barrier to effective treatment for hormone receptor positive breast cancer patients. Adding text message reminders and/or telephone-based counseling to usual care may increase the number of days that patients take their endocrine therapy medication as prescribed.

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 data supports the effectiveness of the treatment Additional Support Program Via Text Messaging and Telephone-Based Counseling for breast cancer patients?

Research shows that text messaging programs can effectively support people with chronic diseases by improving health self-management and self-efficacy. Additionally, mobile health interventions, including text messaging, have been shown to help breast cancer patients manage their health better. ^{1 2 3 4 5}

Is the Support Program for Breast Cancer safe for humans?

The safety of the Support Program for Breast Cancer, which includes text messaging and telephone-based counseling, is supported by studies showing that similar interventions help manage side effects and improve adherence to cancer treatments without causing harm. These programs have been used safely in cancer patients to provide guidance and monitor symptoms. ^{4 6 7 8 9}

How does the Support Program for Breast Cancer differ from other treatments for breast cancer?

The Support Program for Breast Cancer is unique because it uses a mobile application to provide personalized information and a support network for women undergoing chemotherapy, aiming to improve their self-efficacy, social support, and symptom management, which can enhance their quality of life and psychological well-being. ^{2 10 11 12 13}

Research Team

Katherine E. Reeder-Hayes, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Additional Support Program Via Text Messaging and Telephone-Based Counseling (Hormone Therapy)

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.

Participant Groups

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+

Suzanne George

Alliance for Clinical Trials in Oncology

Chief Medical Officer since 2015

MD from Harvard Medical School

Evanthia Galanis

Alliance for Clinical Trials in Oncology

Chief Executive Officer since 2022

MD from Mayo Clinic

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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 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 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]

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 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 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]

References

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

Text Messaging in Oncology: A Review of the Landscape. [2019]

2. England 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. [2020]

3. United States 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. [2021]

4. United States 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. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile health-based self-management interventions in breast cancer patients: a meta-analysis. [2022]

6. United States 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. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Potential clinical impact of therapeutic education in patients treated with anticancer drugs]. [2017]

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

Bidirectional Text Messaging to Monitor Endocrine Therapy Adherence and Patient-Reported Outcomes in Breast Cancer. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Development of a Smartphone Program to Support Adherence to Oral Chemotherapy in People with Cancer. [2022]

10. England 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. [2022]

11. Canada 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. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Telephone counseling of breast cancer patients after treatment: a description of a randomized clinical trial. [2007]

13. Ireland pubmed.ncbi.nlm.nih.gov

Telephone counseling in psychosocial oncology: a report from the Cancer Information and Counseling Line. [2019]