Improving Outcomes for Younger Breast Cancer Survivors: A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 试验地点
- 3
- 主要终点
- Change in depressive symptoms measured by Center for Epidemiologic Studies Depression Scale score
研究概览
简要总结
This randomized phase III trial studies how well mindfulness meditation or survivorship education work in improving behavioral symptoms in younger stage 0-III breast cancer survivors. Behavioral interventions, such as mindfulness meditation, use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Survivorship education after treatment may reduce stress and improve the well-being and quality of life of patients with breast cancer. Mindfulness meditation or survivorship education may help improve the health behaviors of younger breast cancer survivors.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of two different types of group interventions (mindfulness and survivorship education), specifically tailored to the needs of younger female breast cancer survivors, in reducing depressive symptoms, compared to a usual care control group.
SECONDARY OBJECTIVES:
I. To compare the efficacy of the two interventions relative to a usual care control group on fatigue, sleep disturbance, and vasomotor symptoms.
II. To examine the efficacy of the two interventions relative to a usual care control group on circulating and genomic markers of inflammation.
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
- — 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with early stage, resectable breast cancer (Stage 0, I, II, or III) prior to age 50, and are within 5 years of diagnosis
- •Have completed all surgery, radiation, and/or chemotherapy treatments at least 6 months previously; may still be receiving trastuzumab or endocrine adjuvant therapy
- •Ability to complete evaluation surveys in English
- •Have evidence of at least mild clinical depression on a standardized screening questionnaire
排除标准
- •Has a breast cancer recurrence, metastasis, or another interval cancer diagnosis following the breast cancer (excluding non-melanoma skin cancer)
- •Unable to commit to intervention schedule (6 weekly group meetings)
- •Actively practicing mindfulness meditation
- •Has another serious or chronic medical or psychiatric condition that contributes to substantial physical or emotional disability that would detract from participating in either of the intervention programs or from the measurement of intervention outcomes
研究组 & 干预措施
Arm A (MAPs)
Patients attend a mindfulness meditation class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions that include guided meditation, questions, and discussion of how to maintain a mindfulness practice over 1 hour once monthly for 2 months.
干预措施: Laboratory Biomarker Analysis (Other)
Arm A (MAPs)
Patients attend a mindfulness meditation class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions that include guided meditation, questions, and discussion of how to maintain a mindfulness practice over 1 hour once monthly for 2 months.
干预措施: Meditation Therapy (Procedure)
Arm A (MAPs)
Patients attend a mindfulness meditation class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions that include guided meditation, questions, and discussion of how to maintain a mindfulness practice over 1 hour once monthly for 2 months.
干预措施: Questionnaire Administration (Other)
Arm B (SE)
Patients attend a survivorship education class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic newsletters with tailored information about topics of interest to younger survivors, including cancer-related events in the community and tips about following through on recommendations for healthy living.
干预措施: Educational Intervention (Other)
Arm B (SE)
Patients attend a survivorship education class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic newsletters with tailored information about topics of interest to younger survivors, including cancer-related events in the community and tips about following through on recommendations for healthy living.
干预措施: Laboratory Biomarker Analysis (Other)
Arm B (SE)
Patients attend a survivorship education class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic newsletters with tailored information about topics of interest to younger survivors, including cancer-related events in the community and tips about following through on recommendations for healthy living.
干预措施: Questionnaire Administration (Other)
Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP)
Patients receive usual care for 9 months. Patients are then offered a choice of participating in Arm A or Arm B.
干预措施: Educational Intervention (Other)
Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP)
Patients receive usual care for 9 months. Patients are then offered a choice of participating in Arm A or Arm B.
干预措施: Laboratory Biomarker Analysis (Other)
Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP)
Patients receive usual care for 9 months. Patients are then offered a choice of participating in Arm A or Arm B.
干预措施: Meditation Therapy (Procedure)
Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP)
Patients receive usual care for 9 months. Patients are then offered a choice of participating in Arm A or Arm B.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in depressive symptoms measured by Center for Epidemiologic Studies Depression Scale score
时间窗: 2 weeks post-intervention to 6 months
The data will be analyzed using linear mixed effects models, with fixed effects for time and condition and random effects for individuals. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. All tests will be two-sided. The Hochberg procedure will be applied to the two p-values for each intervention to control the familywise error rate at 0.05.
次要结局
- Mediators of intervention efficacy assessed by questionnaire(Up to 6 months)
- Moderators of intervention efficacy assessed by questionnaire(Up to 6 months)
- Change in hot flashes measured by the vasomotor symptom severity subscale of the BCPT symptom scales questionnaire.(2 weeks post-intervention to 6 months)
- Change in sleep disturbance assessed by Insomnia Severity Index(2 weeks post-intervention to 6 months)
- Change in fatigue assessed by Fatigue Symptom Inventory(2 weeks post-intervention to 6 months)
- Change in inflammatory biomarkers will focus on laboratory measurements of Interleukin-6 (IL-6) and high sensitivity C-Reactive Protein (hsCRP)(2 weeks post-intervention to 6 months)