Randomized Control Trial of the Effect of an E-Health Support Program on Patient Reported Outcomes of Women Newly Diagnosed With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 419
- 试验地点
- 2
- 主要终点
- Impact of electronic (e)-health support program on patient reported outcomes
研究概览
简要总结
This trial studies how well an electronic (e)-health support program, called the PACK Health Program, supports patient reported symptoms in newly diagnosed patients with breast cancer. PACK Health offers a symptom management program involving both interpersonal interaction, as well as e-modules for patients diagnosed with cancer to better manage pain, fatigue, depression, anxiety, and to navigate care more effectively through e-health coaching and tools. Participating in the PACK Health Program may support breast cancer patients' reported side effects and experience of care during chemotherapy treatment and may ultimately improve overall health.
详细描述
PRIMARY OBJECTIVE:
I. To examine the impact of an e-health support program on patient reported outcomes.
SECONDARY OBJECTIVES:
I. To evaluate the effect of e-health support program in comparison with standard of care support services, on the symptom experience of patients receiving chemotherapy in the ambulatory setting.
II. To evaluate the effect of e-health support program in comparison with standard of care support services, on the satisfaction of patients receiving chemotherapy in the ambulatory setting.
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
- •English speaking.
- •Newly diagnosed women with a breast cancer diagnosis preparing to undergo chemotherapy for the first time.
- •All chemotherapy treatment to be completed at the study institution.
- •Access to electronic resources, defined for the purposes of this study as a mobile phone, a landline phone, a computer, or another device with the capacity to receive calls, texts, or e-mails.
排除标准
- •Patients who have received previous chemotherapy treatment for cancer.
- •Patients who are unable to verbalize (e.g. due to tracheostomy).
- •Patients enrolled on Protocol 2016-0300, as these patients will be receiving proactive triage calls from nurses that could skew their symptom reporting.
结局指标
主要结局
Impact of electronic (e)-health support program on patient reported outcomes
时间窗: Baseline up to 3 months
Measured with the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale. Summary statistics and box plots will be used to describe PROMIS scores by intervention arm and assessment time. A 2-sample t-test will be used to compare PROMIS scores at 3 months between intervention groups. Linear mixed effects models (LMMs) will be used to assess PROMIS scores over time. The models will include assessment time, intervention and baseline score as fixed effects and intercept as a random effect. Additional models will be created to include possible confounding covariates. PROMIS instrument scores will be reviewed and patients referred to the primary medical team if they score 1 on items 1-6, and 9, indicating poor health state and 4 or greater on items 8 and 10, indicating potential emotional distress or moderate to severe fatigue.
次要结局
未报告次要终点