Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Enrollment Rate
研究概览
简要总结
This research is being done to test a new communication tool for people with ovarian cancer, caregivers, and clinicians.
The name of the intervention in this research study is:
-Collaborative Agenda-Setting Intervention (CASI)
详细描述
This two-arm, parallel group-randomized research study is to test a new communication tool (CASI) for people with ovarian cancer, caregivers, and clinicians. This is a pilot feasibility study, which means this is the first time researchers are studying CASI. Clinicians will be randomized into one of the two study groups, Arm 1 or Arm 2, and patients and caregivers will be enrolled in the study arm to which their clinician has been randomized.
The research study procedures include screening for eligibility, audio recorded clinic visits, and questionnaires.
Participation in this research study is expected to last for up to 12 weeks for patients and caregivers, and for up to 52 weeks for clinicians.
It is expected that up to 112 people will take part in this research study, including up to 50 patients, 50 caregivers, and 12 clinicians (six dyads).
The National Institute for Nursing Research is supporting this research by providing funding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Participant Inclusion Criteria:
- •At least 18 years old
- •Able to speak, understand, and respond to questions written in English
- •Willing to be audio recorded
- •Have a diagnosis of advanced ovarian cancer (defined as stage III, stage IV, or recurrent disease)
- •Be under the care of a participating clinician dyad
- •Be scheduled for chemotherapy during the recruitment period
- •Be signed up or willing to sign up for Patient Gateway
- •Caregiver Inclusion Criteria:
- •At least 18 years old
- •Able to speak, understand, and respond to questions written in English
- •Willing to be audio recorded
- •Be a family member, partner, or friend of a patient participant with whom the patient participant discusses their cancer care
- •Clinician Inclusion Criteria:
- •Be employed at DFCI as an oncologist, nurse practitioner, or physician assistant
- •Take care of at least 4 patients per month with advanced ovarian cancer (defined as stage III, stage IV, or recurrent disease) in the outpatient setting
- •Participant
排除标准
- •Age of <18 years
- •Unable to consent
研究组 & 干预措施
Arm 1: CASI Intervention
Enrolled patients and caregivers will complete:
- Audio recorded baseline visit
- CASI via mobile device, laptop, or desktop computer 1 week prior to CASI visit 1
- Audio recorded CASI visit 1
- CASI via mobile device, laptop, or desktop computer 1 week prior to CASI visit 2
- Audio recorded CASI visit 2
- CASI via mobile device, laptop, or desktop computer 1 week prior to CASI visit 3
- Audio recorded CASI visit 3
- End of study visit
For each enrolled patient, enrolled clinicians will complete:
- Audio recorded baseline visit
- Audio recorded CASI visit 1
- Audio recorded CASI visit 2
- Audio recorded CASI visit 3
Enrolled clinicians will also complete:
- Baseline visit, one time
- End of study visit, one time
干预措施: Collaborative Agenda-Setting Intervention (Behavioral)
Arm 2: Control
Enrolled patients and caregivers will complete:
- Audio recorded baseline visit
- Audio recorded visit 1 will proceed according to usual, oncology care
- Audio recorded visit 2 will proceed according to usual, oncology care
- Audio recorded visit 3 will proceed according to usual, oncology care
- End of study visit
For each enrolled patient, enrolled clinicians will complete:
- Audio recorded baseline visit
- Audio recorded visit 1 will proceed according to usual, oncology care
- Audio recorded visit 2 will proceed according to usual, oncology care
- Audio recorded visit 3 will proceed according to usual, oncology care
Enrolled clinicians will also complete:
- Baseline visit, one time
- End of study visit, one time
结局指标
主要结局
Enrollment Rate
时间窗: Pre-consent
The proportion of approached participants that are enrolled. Feasibility of an efficacy trial is defined as ≥60% enrollment among approached participants.
次要结局
- Proportion of Participant-Rated Intervention Burden(Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment)
- Proportion of Participant-Rated Intervention Helpfulness(Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment)
- Change in FACT-G Score from Baseline to 12 Weeks (Arm 2)(Baseline and 12 weeks after enrollment)
- Change in the Functional Assessment of Cancer Therapy - General (FACT-G) Score from Baseline to 12 Weeks (Arm 1)(Baseline and 12 weeks after enrollment)
- Acceptability of Intervention(Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment)
研究者
Rachel Pozzar
Principal Investigator
Dana-Farber Cancer Institute