A Randomized Phase III Trial Comparing Active Symptom Monitoring Plus Patient Education Versus Patient Education Alone to Improve Persistence With Endocrine Therapy in Young Women With Stage I-III Breast Cancer (ASPEN)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 565
- 试验地点
- 977
- 主要终点
- Persistence with initially prescribed oral estrogen (ET) medication
研究概览
简要总结
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.
详细描述
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 Voils 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must be female and have Stage I, II, or III hormone receptor positive breast cancer based on clinical or pathologic evaluation
- •Participants must have been pre- or peri-menopausal at the time of breast cancer diagnosis by satisfying one of the following:
- •had a menstrual period (by self-report) within the 12 months before breast cancer diagnosis, or
- •had a serum or plasma estradiol and/or follicle stimulating hormone (FSH) concentration consistent with premenopausal status (based on institutional standards) within the 12 months before breast cancer diagnosis or when checked after breast cancer diagnosis
- •Participants must have started initial treatment with standard of care oral endocrine therapy (ET) (i.e., tamoxifen, anastrozole, exemestane, or letrozole; within 14 days prior to randomization or be planning to start initial treatment with standard of care oral ET within 14 days after randomization
- •Participants who currently have ovarian function (estradiol above the postmenopausal range) must be planning to undergo ovarian suppression or ablation concomitantly with oral ET medication, starting before or at the same time as oral ET initiation. Participants with chemotherapy-induced amenorrhea or ovarian failure at time of registration must be planning to start ovarian suppression or ablation if they have recurrence of ovarian function during study participation (circulating estradiol concentration in the premenopausal range or recurrence of menses)
- •Participants must have completed surgery for treatment of breast cancer at least 14 days prior to randomization NOTE: Concomitant radiotherapy at the time of randomization and/or during study participation is allowed
- •Participants who received chemotherapy must have finished it at least 14 days prior to randomization NOTE: Concomitant maintenance targeted or biologic therapy (e.g., human epidermal growth factor receptor 2 [anti-HER2] therapy, poly-ADP ribose polymerase [PARP] inhibitor therapy, CDK4/6 inhibitor therapy, osteoclast inhibitor therapy) at the time of randomization and/or during study participation is allowed
- •Participants must be >= 18 years of age
- •Participants must have a complete medical history within 60 days prior to randomization
- •Participants must be able to complete Patient-Reported Outcome (PRO) instruments in English or Spanish
- •Participants must:
- •agree to complete PROs at all scheduled assessments and
- •complete the pre-registration (baseline) PRO forms within 14 days prior to randomization
- •Participants must be able to complete symptom questions on a web browser (on a smartphone, tablet, or computer) or respond via voice on a telephone in English or Spanish. Participants must agree to complete symptom questions at all scheduled assessments NOTE: Participants who do not have access to the internet and who cannot receive telephone calls for interactive voice response system (IVRS) assessments are not eligible
- •Participants must be offered the opportunity to participate in specimen banking for translational medicine. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) specimen tracking system
- •Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
排除标准
- •Participants must not have distant metastatic breast cancer
- •Participants who have started or plan to start treatment with tamoxifen during study participation must not have received prior tamoxifen for treatment or prevention of breast cancer
- •Participants who have started or plan to start treatment with an aromatase inhibitor during study participation must not have received prior aromatase inhibitor therapy for treatment or prevention of breast cancer
- •Participants must not be taking or planning to take oral estrogen-or progesterone-containing treatments during study participation
- •Participants who start or plan to start treatment with an aromatase inhibitor may have previously received tamoxifen for prevention of breast cancer or treatment of a prior cancer
- •Participants may have received prior treatment with an aromatase inhibitor for infertility treatment
- •Participants must not be planning to become pregnant during the 80 weeks of study participation
- •Participants must not receive additional anti-cancer treatments (i.e., experimental therapy, immunotherapy, biologics, etc.) as part of another clinical trial
- •Participants must not have a non-breast malignancy for which they are currently receiving treatment
结局指标
主要结局
Persistence with initially prescribed oral estrogen (ET) medication
时间窗: From randomization to discontinuation of the initially prescribed ET for more than 60 days or switching to a new oral ET medication, assessed up to 72 weeks
Will be assessed by the treating provider at each study visit every 12 weeks and prospectively documented on the S2010 treatment log, including any switch from the initially prescribed oral ET. Persistence with initially prescribed oral ET by intervention arm out to 72 weeks will be described using Kaplan-Meier plots. Potential differences by arm will be tested using multivariable Cox regression. Persistence with any oral ET (aromatase inhibitor \[AI\] and/or tamoxifen) at 72 weeks by arm will be examined in a consistent manner. The study stratification variables (age \[\< 45 vs \>= 45\], chemotherapy \[yes/no\], and ET \[AI vs tamoxifen\]), as well as race, ethnicity, and disease stage, will be included as covariates in the regression models. In the timeframe of evaluation, censored events (newly diagnosed cancer, cancer recurrence, or death) are anticipated to be low.
次要结局
- Incidence of hot flashes(Up to 12 weeks)
- Occurrence of any non-adherence(Up to 18 months)
- Worst pain(Up to 12 weeks)