Parmar V, Badwe R A, Hawaldar R, Rayabhattanavar S, Varghese A, Sharma R, Mittra I
Breast Unit, Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India.
Natl Med J India. 2005 Jul-Aug;18(4):172-7.
The European Organization for Research and Treatment of Cancer (EORTC) module QLQ-C30 and the breast cancer-specific module BR-23 have been validated worldwide to assess the quality of life (QOL) in women with breast cancer. No such study has been published on Indian women using EORTC questionnaires.
QOL was assessed in relation to surgery, adjuvant chemotherapy, radiation therapy and hormone therapy in 299 Indian women with operable breast cancer (OBC) at the Breast Unit of Tata Memorial Hospital (TMH), Mumbai, from October 1998 to September 2001. The QLQ-C30 module was used to assess physical health, emotional, cognitive and social functioning, and the BR-23 module to assess breast cancer treatment-related symptoms. Assessment was done at 3 visits: visit 1 (after surgery); visit 2 (during adjuvant therapy) and visit 3 (on completion of adjuvant therapy).
Of the 299 women at first visit, 274 (91.6%) completed the visit 2 questionnaire and 239 (80%) completed the visit 3 questionnaire. Only those women who filled the questionnaires at all 3 visits were included as 'valid visits' for analysis (193 of 299; 64.5%). The reliability and validity of the English and translated versions of the questionnaires were tested by Cronbach alpha (0.61-0.96) and item-scale correlation (0.63-0.93). Women with breast conservation treatment had a superior body image as compared to those with mastectomy (p <0.001). Physical, emotional and cognitive functions were not related to the type of surgery. Global QOL, physical, sexual and role functioning were found to deteriorate with chemotherapy (p < or = 0.01). Radiotherapy had only local adverse effects (p < 0.001 ), while hormone therapy had no adverse impact on QOL.
QLQ-C30 and BR-23 questionnaires can be used reliably to assess QOL in Indian patients. The translated versions were found to be valid for further use in clinical trials on Indian women with breast cancer.
欧洲癌症研究与治疗组织（EORTC）的QLQ-C30模块以及乳腺癌特异性模块BR-23已在全球范围内得到验证，用于评估乳腺癌女性的生活质量（QOL）。尚未有关于使用EORTC问卷对印度女性进行此类研究的报道。
1998年10月至2001年9月期间，在孟买塔塔纪念医院（TMH）乳腺科对299例可手术乳腺癌（OBC）印度女性进行了与手术、辅助化疗、放疗和激素治疗相关的生活质量评估。QLQ-C30模块用于评估身体健康、情绪、认知和社会功能，BR-23模块用于评估与乳腺癌治疗相关的症状。评估在3次就诊时进行：就诊1（手术后）；就诊2（辅助治疗期间）和就诊3（辅助治疗完成时）。
在首次就诊的299名女性中，274名（91.6%）完成了就诊2问卷，239名（80%）完成了就诊3问卷。仅将在所有3次就诊时填写问卷的女性纳入作为分析的“有效就诊”（299名中的193名；64.5%）。通过Cronbach阿尔法系数（0.61 - 0.96）和项目 - 量表相关性（0.63 - 0.93）对问卷英文和翻译版本的信度和效度进行了测试。与接受乳房切除术的女性相比，接受保乳治疗的女性身体形象更好（p <0.001）。身体、情绪和认知功能与手术类型无关。发现总体生活质量、身体、性功能和角色功能随着化疗而恶化（p≤0.01）。放疗仅产生局部不良反应（p <0.001），而激素治疗对生活质量没有不良影响。
QLQ-C30和BR-23问卷可可靠地用于评估印度患者的生活质量。发现翻译版本可有效用于对印度乳腺癌女性的进一步临床试验。
