Quality of Life Outcomes From a Peer-to-Peer Support Program for Women With Gynecologic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Satisfaction of mentors with the timing, content, and format of the program, as assessed by the W2W Volunteer/Mentor Survey
研究概览
简要总结
This pilot clinical trial studies a peer-to-peer support program in improving quality of life outcomes in patients with gynecologic cancer and their caregivers. Peer-to-peer support and mentoring may help improve quality of life and reduce symptoms of distress in gynecologic cancer patients and their families.
详细描述
PRIMARY OBJECTIVES:
I. To test the feasibility and acceptability of a Woman-to-Woman (W2W) program for patients with gynecologic cancer at City of Hope (COH). Address the following descriptive research questions: were patients, mentors, and patients' family caregivers satisfied with the timing, format, and content of the program? Did the program benefit patients, mentors, and patients' family caregivers?
OUTLINE:
Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.
After completion of study, patients are followed up at 6 and 12 months.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •PATIENT PARTICIPANTS
- •Patients with newly diagnosed or recurrent gynecologic cancer (ovarian, uterine, cervical, vaginal, vulvar) actively undergoing treatment (chemotherapy, surgery, or radiation therapy) at COH (including Duarte and South Pasadena campuses)
- •English-speaking patients
- •PEER MENTORS
- •Peer mentors will be past gynecologic cancer patients not currently undergoing treatment for their cancer, and considered without evidence of disease
- •Over age 18
- •PEER MENTORS: English-speaking patients
- •This study is open to patients of all races and ethnicities
排除标准
- •PEER MENTORS:
- •Major psychiatric disease
- •Currently undergoing treatment for active gynecologic cancer
研究组 & 干预措施
Supportive care (W2W program)
Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.
干预措施: Supportive Care (Procedure)
Supportive care (W2W program)
Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.
干预措施: Quality-of-Life Assessment (Other)
Supportive care (W2W program)
Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Satisfaction of mentors with the timing, content, and format of the program, as assessed by the W2W Volunteer/Mentor Survey
时间窗: Up to 12 months
Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools.
Change in quality of life benefits for patients, as assessed by the FACT-G
时间窗: Baseline to up to 12 months
Changes from baseline will be tested using paired t-tests. Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. Written comments from all open ended questions analyzed using content analysis methods.
Satisfaction of patients with the timing, content, and format of the program, as assessed by the W2W Patient Survey
时间窗: Up to 12 months
Changes from baseline will be tested using paired t-tests. Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools. Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data.
Satisfaction of patients' family caregivers with the timing, content, and format of the program
时间窗: Up to 12 months
Changes from baseline will be tested using paired t-tests. Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools.
Benefits for patients' family caregivers after participating in the program, as assessed by the Modified Caregiver Strain Index
时间窗: Up to 12 months
Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. Written comments from all open ended questions analyzed using content analysis methods.
次要结局
未报告次要终点