A Nurse-Led Intervention to Enhance Quality of Life Among Early Phase Clinical Trial Participants: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Intervention Acceptability
研究概览
简要总结
The purpose of this study is to pilot test a brief, population-specific nurse-led, quality of life (QOL) intervention with early phase cancer clinical trial (EP-CT) participants.
The name of the intervention used in this research study is:
-Nurse-Led Quality of Life Intervention (comprised of nurse-patient relationship, assessment and monitoring of participant QOL, and interdisciplinary team meetings led by the CRN (clinical research nurse).
详细描述
This is a single-site study evaluating the feasibility and acceptability as well as patient-reported and clinical outcomes of a nurse-led, quality of life intervention with EP-CT participants.
The research study procedures include obtaining consent to participate, meeting with research nurses monthly for three months, completing questionnaires, and an interview with the study staff at the end of the study.
Participation in this research study is expected to be for a total of six months.
It is expected that about 35 people, 25 caregivers, and 10 clinicians will take part in this research study.
The Oncology Nursing Foundation is supporting this research study by providing funding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age.
- •Adults with cancer enrolled on an EP-CT in the Termeer Center at Massachusetts General Hospital.
- •Able to read and respond to questions in English.
- •Caregiver Inclusion Criteria:
- •A relative or friend of the eligible patient whom the patient identifies as being involved in their medical care.
- •> 18 years of age.
- •Verbally fluent in English.
- •Clinician Inclusion Criteria:
- •Clinician must be an oncology nurse.
- •CRN for a minimum of 18 months.
- •fulltime employee in the Termeer Center.
排除标准
- 未提供
结局指标
主要结局
Intervention Acceptability
时间窗: Baseline to 3 months
Acceptability is defined as \> 70% of patients, caregivers, and clinicians report favorable responses to the acceptability questions.
Rate of Participant Enrollment
时间窗: At screening
The study will be feasible if at least 60% (95% confidence interval of +/-12%) enrollment of approached and eligible patients agree to participate in the study and sign informed consent
Rate of Participant Assessment Completion
时间窗: Baseline to 3 months
This study will be feasible if at least 70% (95% confidence interval of +/- 15%) of enrolled participants will complete a minimum of 60% of their patient-reported symptom assessments within the study period.
次要结局
- Change in Quality of Life (QOL)(Baseline to 3 months)
- Change in Coping(Baseline to 3 months)
- Change in Financial Well-Being(Baseline to 3 months)
- Change in Symptom Burden(Baseline to 3 months)
- Change in Social Isolation(Baseline to 3 months)
- Change in Prognostic Awareness(Baseline to 3 months)
- Percentage of Participants Completing Dose-Limiting Toxicity (DLT) Period(1 year)
- Number of Emergency Department Visits(Through study completion, an average of two years)
- Change in Anxiety(Baseline to 3 months)
- Change in Spiritual Wellbeing(Baseline to 3 months)
- Utilization of Supportive Care Services(Through study completion, an average of two years)
- Change in Symptom Management(Baseline to 3 months)
- Change in Hope(Baseline to 3 months)
- Number of Days on Trial(Through study completion, an average of two years)
- Survival(Through study completion, an average of two years)
- Percentage of Hospice Utilization(Through study completion, an average of two years)
- Change in Depression(Baseline to 3 months)
- Change in Perception of the Nurse-Patient Relationship(At 3 months)
研究者
Debra Marie Lundquist, R.N.
Principal Investigator
Massachusetts General Hospital