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Monitoring Symptoms to Help Young Women Take Hormone Therapy for Stage I-III Breast Cancer, ASPEN Study


Active: Yes
Cancer Type: Breast Cancer
Unknown Primary
NCT ID: NCT05568472
Trial Phases: Phase III Protocol IDs: SWOG-S2010 (primary)
S2010
SWOG-S2010
NCI-2022-06902
Eligibility: 18 Years and older, Female Study Type: Supportive care
Study Sponsor: SWOG
NCI Full Details: http://clinicaltrials.gov/show/NCT05568472

Summary

This phase III trial compares the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III breast cancer stay on their hormone therapy medicines. The patient education tool contains interactive weblinks which provide patients with education material about breast cancer and side effects of therapy. Symptom monitoring is a weblink via email or text message with questions asking about symptoms. Hormone therapy for breast cancer can cause side effects, and may cause some women to stop treatment early. Asking about symptoms more often may help women keep taking hormone therapy medicines.

Objectives

PRIMARY OBJECTIVE:
I. To compare persistence with the initially prescribed oral endocrine therapy (ET) through 72 weeks for young women being treated for hormone-receptor positive stage I-III breast cancer randomized to Active Symptom Monitoring (ASM) + patient education or patient education alone.

SECONDARY OBJECTIVES:
I. To compare patient-reported adherence with the initially prescribed oral ET over time as assessed with the DOSE-Nonadherence measure between the two arms.
II. To compare worst pain as assessed with the Brief Pain Inventory, in aromatase inhibitors-treated (AI-treated) participants over time between the two arms.
III. To compare hot flashes as assessed with the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Endocrine Symptoms Scale in tamoxifen-treated participants over time between the two arms.

EXPLORATORY OBJECTIVES:
I. To describe key treatment-emergent symptoms as assessed with the Brief Pain Inventory, the Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile, the PROMIS Cognitive Function, and the FACT-ES Endocrine Symptoms Scale over time between the two arms.
II. To develop a composite risk prediction model (including demographics, socioeconomic variables, and clinical variables) to identify participants who are most likely to benefit from ASM.
III. To examine associations between baseline symptom bother as assessed with the GP5 item from the FACT-ES and persistence with oral ET.
IV. To examine the pattern by arm of treatment toxicity from the oral ET agents that are prescribed in this study over time during the first 24 weeks.
V. To compare biochemically determined adherence with the initially prescribed oral ET as assessed with centrally evaluated drug concentrations and metabolites between ASM + patient education and patient education alone over time.
VI. To examine associations overall and by arm between baseline estradiol concentrations evaluated centrally and development of treatment-emergent symptoms as assessed with the Brief Pain Inventory, the PROMIS-29 Profile, the PROMIS Cognitive Function, and the FACT-ES Endocrine Symptoms Scale.
VII. To determine patterns of change overall and by arm in centrally evaluated estradiol concentrations during study participation in participants with chemotherapy-induced ovarian failure, those receiving gonadotrophin releasing hormone (GnRH) agonist therapy, and those who had undergone bilateral salpingo-oophorectomy.
VIII: To identify inherited genetic variants using genome-wide genotyping that contribute to development of endocrine therapy-emergent toxicity.

BANKING OBJECTIVE:
I. To bank specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive ET and standard of care clinic visits with a cancer provider at 12, 24, 36, 48, 60, and 72 weeks, and phone visit at 80 weeks to access ongoing use ET medication. Patients are asked 6 brief questions about symptoms weekly by email, text, or phone call for the first 6 months, then every 4 weeks for 12 months. Patients also receive a list of websites with information about breast cancer, side effects of breast cancer medicines, and ways to help with heart health. Patients have the option to submit blood specimen collection at baseline, 3, 12, and 18 months.

ARM II: Patients receive ET and standard of care clinic visits with a cancer provider at 12, 24, 36, 48, 60, and 72 weeks, and phone visit at 80 weeks to access ongoing use ET medication. Patients also receive a list of websites with information about breast cancer, side effects of breast cancer medicines, and ways to help with heart health. Patients have the option to submit blood specimen collection at baseline, 3, 12, and 18 months.

Treatment Sites in Georgia

City of Hope Atlanta
600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center



Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com



Pearlman Cancer Center at South Georgia Medical Center
2501 North Patterson Street
Valdosta, GA 31602
229-259-4628
www.sgmc.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.