BOLSTER: Building Out Lifelines for Safety, Trust, Empowerment and Renewal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Feasibility of the BOLSTER Intervention
研究概览
简要总结
This research study is evaluating a new intervention, BOLSTER, which was designed to provide more support for patients with gynecologic and gastrointestinal cancers and their caregivers after a hospitalization.
详细描述
Hospitalizations can be difficult for patients with cancer, especially when they are transitioning home. Patients and caregivers are often expected to perform complex medical and nursing tasks with little or no preparation. Patients and caregivers report high levels of unmet needs for information about how best to manage symptoms and new medical procedures (such as managing new tubes, lines or drains).
The study team has developed a research project which aims to address these needs. If a patient agrees to participate in the study, she will take part in a program called BOLSTER (Building Out Lifelines for Safety, Trust, Empowerment and Renewal). BOLSTER will provide patients and caregivers with education and skills training, symptom management, and support across care settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinical research assistant blinded to randomized study arms; will conduct structured interview at baseline, prior to randomization, and 4 weeks post randomization +/- 2 weeks.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient inclusion criteria
- •Adults (≥18 years old);
- •GYN or GI cancers receiving anti-neoplastic therapy;
- •Hospitalized, recently hospitalized (i.e. within the first 2 visits after a hospitalization), or recent outpatient placement of tube, line, or drain (e.g. PleurX catheter);
- •Plan to receive ongoing care at DFCI;
- •Willingness to be audio taped for the study (for monitoring of study fidelity).
- •Have complex care needs (e.g. an ostomy, ileostomy, a gastric tube, percutaneous nephrostomy tubes, a PleurX catheter, or need for total parenteral nutrition)
排除标准
- •Unable to read and respond to questions in English;
- •Cognitive impairment;
- •Unable to complete the baseline interview;
- •Plan for immediate hospice referral
- •Caregiver inclusion criteria
- •Adults (≥18 years old);
- •Family member or friend of an eligible patient;
- •Willingness to be audio taped for the study (for monitoring of study fidelity);
- •Willingness to participate in study visits
- •Caregiver exclusion criteria:
- •Unable to read and respond to questions in English,
- •Cognitive impairment
- •Unable to complete the baseline interview
研究组 & 干预措施
Bolster
- Bolster provides participants with longitudinal nursing support across care settings,
- A smartphone-based symptom management app,
- A print and web-based symptom management toolkit,
- Advance care planning to ensure that the patient receives care that is congruent with her informed preferences
- BOLSTER includes a total of 6 contacts with a study nurse over 4 weeks
- Daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice
干预措施: BOLSTER (Behavioral)
Enhanced Discharge Planning (EDP)
- Medication education,
- Self-management strategies for symptoms,
- Skills training,
- A list of red flag symptoms and numbers for who to call
干预措施: Enhanced Discharge Planning (EDP) (Other)
结局指标
主要结局
Feasibility of the BOLSTER Intervention
时间窗: 1 month
≥50% consent-to-approach ratio
次要结局
- Acceptability of the BOLSTER Intervention(3 months)
研究者
Alexi A. Wright, MD
Principal Investigator
Dana-Farber Cancer Institute