Telephone Counseling With Men With Prostate Cancer and Partners
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Social Well Being
研究概览
简要总结
The purpose of this project is to test a telephone delivered educational support program versus an education only program for improving symptom management and quality of life in men with prostate cancer and their partners.
详细描述
Eligibility Criteria for men: receiving treatment for prostate cancer,over 21 years of age, English speaking, have access to and ability to talk on the phone and have a partner willing to participate in the study. Participants can live anywhere in the United States because the intervention is telephone delivered.
Partners can be anyone the man selects (friend or relative) who is over 21 years of age, English speaking and has access to or ability to speak on the phone.
Men and their partners will be assigned to one of two groups. Each survivor will receive 8 telephone calls over an 8-week period for about 30 minutes each. Each partner will receive 4 telephone calls every other week for about 30 minutes each. We will ask everyone to complete a baseline assessment over the telephone, after the 8 weeks, and then again about 8 weeks after the second assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving treatment for prostate cancer
- •Over 21 years
- •Access to and ability to talk on the phone
- •Speaks English and has a partner to participate with him.
- •Partners are anyone who the man chooses (friend or relative) who is over 21 years, English speaking and has access and ability to talk on the phone.
排除标准
- •under 21 years
- •Does not speak English
研究组 & 干预措施
Telephone Interpersonal Counseling
Telephone delivered interpersonal counseling support intervention. Intervention was for 8 weeks. Participants were called on the telephone each week for about 30 minutes.
干预措施: Telephone Interpersonal Counseling (Behavioral)
Telephone delivered education only
Telephone delivered education only. Educational topics included prostate cancer health, side effects, physical activity, diet. Participants were called on the telephone each week for about 30 minutes.
干预措施: Telephone delivered education only (Behavioral)
结局指标
主要结局
Social Well Being
时间窗: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Measures social well-being using the 9 item Social Well-being scale, ranging from 9-90. Higher score indicates increased social well-being.
Center for Epidemiological Studies-Depression Scale
时间窗: 3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks
Depression was measured by the 20-item Center for Epidemiological Studies-Depression (CES-D) scale, Range is 0-60. Scores are added together with higher score greater depression.
Positive Affect
时间窗: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect.
Spiritual Well Being
时间窗: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Measures if spiritual beliefs using a 7-item scale that ranges from 7-70. Higher score equals greater spiritual wellbeing.
Perceived Stress
时间窗: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Perceived stress scale is a 10-item scale with a range of 0-40. Higher scores indicate more stress.
Negative Affect
时间窗: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect.
Multidimensional Fatigue Inventory
时间窗: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Measure of physical well-being, specifically fatigue, using the Multidimensional Fatigue Scale. Scores range from 0-80 with higher scores indicative of more fatigue.
次要结局
未报告次要终点
研究者
Terry Badger
Professor
University of Arizona