Ganz P A, Day R, Ware J E, Redmond C, Fisher B
Division of Cancer Prevention and Control Research, Jonsson Comprehensive Cancer Center, UCLA 90024, USA.
J Natl Cancer Inst. 1995 Sep 20;87(18):1372-82. doi: 10.1093/jnci/87.18.1372.
The Breast Cancer Prevention Trial (BCPT) is a large, multicenter chemoprevention trial testing the efficacy of the antiestrogen drug tamoxifen for prevention of breast cancer and coronary heart disease in healthy women at high risk of breast cancer. The BCPT evolved from a series of prior studies in early stage breast cancer demonstrating the efficacy of tamoxifen in the prevention of systemic breast cancer recurrence and in the reduction of contralateral breast cancers.
The purpose of this article is to describe the methodologic considerations in the collection of health-related quality-of-life (HRQL) data in the BCPT and to present base-line HRQL data on the first 9749 participants.
An HRQL questionnaire that included the Center for Epidemiologic Studies-Depression Scale, a symptom checklist, the Medical Outcomes Study 36-item short form (MOS-SF-36), and the MOS sexual problems questions was completed by participants in the BCPT at base line (prior to random assignment). Medical and demographic information, as well as projected risk of breast cancer, were collected as part of study eligibility. Descriptive and correlational data were examined for these study participants.
BCPT participants report high levels of functioning compared with U.S. general population norms but still report an average of 8.9 distinct symptoms during the past 4 weeks. Depression is less prevalent among the participants than in community samples, which reflects the exclusion of clinically depressed individuals. Sixty-five percent reported being sexually active in the past 6 months, with an age-related decline in sexual activity. Younger women reported fewer sexual problems than older women. There is a strong correlation between the two mental health measures, moderate to weak correlations between HRQL scales and levels of self-reported symptoms, and only weak correlations between measures of breast cancer risk and HRQL scales. The MOS-SF-36 scores were examined for three consecutive recruitment samples (0-6 months, 7-12 months, and 13-20 months), and the base-line scores were slightly better for the earliest group of participants.
This article demonstrates the feasibility of collecting HRQL data in a large, multicenter, chemoprevention trial for women at high risk of breast cancer. The successful integration of HRQL data collection into this clinical trial attests to its value as a safety-monitoring end point and as an explicit and measurable outcome for the entire trial.
HRQL data are important for studies in which healthy populations are involved and in which the potential for decrements in quality of life are real or perceived.
乳腺癌预防试验（BCPT）是一项大型多中心化学预防试验，旨在测试抗雌激素药物他莫昔芬对乳腺癌高危健康女性预防乳腺癌和冠心病的疗效。BCPT源于一系列早期乳腺癌的前期研究，这些研究证明了他莫昔芬在预防全身性乳腺癌复发和减少对侧乳腺癌方面的疗效。
本文旨在描述BCPT中与健康相关的生活质量（HRQL）数据收集的方法学考量，并呈现前9749名参与者的基线HRQL数据。
一份HRQL问卷由BCPT的参与者在基线时（随机分组前）完成，问卷包括流行病学研究中心抑郁量表、症状清单、医学结局研究36项简表（MOS-SF-36）以及MOS性问题问卷。收集医学和人口统计学信息以及乳腺癌的预计风险作为研究入选标准的一部分。对这些研究参与者的描述性和相关性数据进行了检查。
与美国一般人群标准相比，BCPT参与者报告的功能水平较高，但在过去4周内平均仍报告有8.9种不同症状。参与者中抑郁症的患病率低于社区样本，这反映了排除了临床抑郁症患者。65%的人报告在过去6个月中有性活动，性活动随年龄下降。年轻女性报告的性问题比老年女性少。两种心理健康测量指标之间存在很强的相关性，HRQL量表与自我报告症状水平之间存在中度到弱的相关性，乳腺癌风险测量指标与HRQL量表之间只有弱相关性。对连续三个招募样本（0 - 6个月、7 - 12个月和13 - 20个月）的MOS-SF-36得分进行了检查，最早一组参与者的基线得分略好。
本文证明了在一项针对乳腺癌高危女性的大型多中心化学预防试验中收集HRQL数据的可行性。将HRQL数据收集成功整合到该临床试验中证明了其作为安全监测终点以及整个试验明确且可测量结果的价值。
HRQL数据对于涉及健康人群且生活质量可能实际下降或被认为会下降的研究很重要。
