Expressive Disclosure Program for Colorectal Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- To collect information about factors affecting colon and rectal cancer patients' quality of life (QOL) in order to develop a QOL program.
研究概览
简要总结
This is a Two-part Pilot Study: Part 1 is descriptive and Part 2 is a pilot randomized trial.
Part 1 will be a formative study in which individual interviews are conducted with 20 patients previously diagnosed with colorectal cancer. During open-ended interviews, researchers will collect data on QOL issues colorectal cancer patients face and will elicit feedback regarding development of and participation in a pilot expressive disclosure intervention. Patients also will pilot test an assessment procedures including completing the written questionnaires and wearing the Electronically Activated Recorder (EAR).
Part 2 will include a small randomized pilot test in which 44 patients (two cohorts of 22 patients) will be randomly assigned to the Expressive Disclosure Group Program or a Standard Care Control Group.
Aims of the study include:
- To conduct a descriptive study of colorectal cancer patients, through qualitative interviews and standardized questionnaires, in an effort to assess their QOL, specific health and emotional problems, issues related to social functioning, and preferences regarding intervention format and logistics.
- To use the information from the descriptive study to develop an Expressive Disclosure Group Program for colorectal cancer patients.
- To pilot test a novel technology called the Electronically Activated Recorder (EAR) for assessing cognitive processing and social support in colorectal cancer patients and compare these data to those obtained with traditional self-report measures.
- To pilot test the Expressive Disclosure Group Program and conduct process evaluation including rates of recruitment and retention, attendance, satisfaction, barriers to participation, and feasibility of randomization.
- To explore the effects of the Expressive Disclosure Group Program on outcome variables of QOL and psychological functioning and mediating variables of cognitive processing, coping skills, and social support.
详细描述
Colon and rectal cancer patients will be asked to participate in this study.
Part 1:
Participation in this study will include three tasks:
First, you will participate in individual interviews during which questions about quality of life will be asked. You also will be provided information about a new expressive disclosure group program for colon and rectal cancer patients, after which you will be asked your opinions about the program. The entire individual interview will last 30 minutes to 1 hour. The interviews will be audiotaped, and then the study staff will make a written copy of the answers given on the tapes to be used in analysis.
Second, you will be asked to complete questionnaires about your medical history, quality of life, mood, thought processes, coping style, and social support. It will take about 1 hour to complete the questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Part 1 - Descriptive Study:
- •having a diagnosis of stage I, II, or III colon or rectal cancer;
- •having completed treatment for colon or rectal cancer within the past year;
- •having the ability to read, speak and write English;
- •being a resident of the State of Texas; and
- •being 18 years old or older.
- •Part 2 - Pilot Randomized Trial:
- •having a diagnosis of stage I, II, or III colon or rectal cancer;
- •having completed treatment for colon or rectal cancer;
- •being a distressed patient: a T score >63 on the Global Severity Index (GSI) of the Brief Symptom Inventory (BSI) or a T score >63 on any two primary dimensions of this measure;
- •having the ability to read, speak and write English;
- •residing within one hour of M.D. Anderson Cancer Center; and
- •being 18 years old or older.
排除标准
- •Part 1 - Descriptive Study:
- •Not being able to provide informed consent.
- •Part 2 - Pilot Randomized Trial:
- •Not being able to provide informed consent.
结局指标
主要结局
To collect information about factors affecting colon and rectal cancer patients' quality of life (QOL) in order to develop a QOL program.
时间窗: 3 years
次要结局
- To look at acceptability of an Expressive Disclosure Group Program for colon and rectal cancer patients, and examine its effect on quality of life.(3 years)