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临床试验/NCT03407768
NCT03407768已完成不适用

Role of Individualized Intervention(s) on Quality of Life and Adherence to Adjuvant Endocrine Therapy in Premenopausal Women With Early-Stage Breast Cancer

University of Saskatchewan3 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
3
主要终点
Functional Assessment of Cancer Therapy - Breast Symptom Index (FACT-B)

研究概览

简要总结

Although combination endocrine therapy has been associated with significant reduction in risk of recurrence in younger women with hormone receptor positive breast cancer, it has been associated with more adverse effects and decline in quality of life (QOL). Various behavioral and complementary interventions can be effective in reducing treatment-related side effects. The study aims to evaluate if individually-tailored behavioral and complementary interventions could improve treatment tolerance and adherence in women with early stage breast cancer. This benefit will be assessed primarily by change in QOL and secondarily by adherence to adjuvant endocrine treatment.

详细描述

Recent evidence suggest that ovarian suppression in combination with exemestane compared with tamoxifen alone has been associated with significant reduction in risk of breast cancer recurrence in premenopausal women with high risk estrogen or progesterone receptor positive breast cancer. However, combination therapy has been associated with more adverse effects, poor treatment adherence, and decline in quality of life (QOL). Various behavioral and complementary interventions such as exercise, yoga, acupuncture, and massage therapy can be effective to reduce treatment-related side effects and thereby to improve QOL. Nevertheless, there is a paucity of evidence about effect of individualized behavioral and complementary interventions in younger women who are treated with combination endocrine therapy. The study aims to evaluate if younger women with early stage breast cancer treated with combination endocrine therapy could benefit from individualized behavioral and complementary intervention (s) during their treatment. This benefit will be assessed primarily by change in QoL and cognitive function from the baseline measurement and secondarily by adherence to adjuvant endocrine treatment. Furthermore, the study will explore correlation between selection of intervention(s) and various socio-demographic and clinical factors. Forty premenopausal women with early stage breast cancer treated with combination endocrine therapy will be recruited over a two year period in Saskatchewan with a median follow up period of about two years. All participants will be provided a list of interventions that alone or in combination could be helpful to improve treatment tolerance to hormonal therapy. A participant will be able to select one or more intervention based on her preferences. The QOL and cognitive function will be assessed every three months using Functional Assessment of Cancer Therapy - Breast Symptom Index (FACT-B), FACT - Endocrine System (FACT-ES), and FACT-Cognitive Function scales. Treatment adherence will be monitored monthly basis. Individually-tailored behavioral and complementary interventions could promote self-management and empower the women with early stage breast cancer to manage treatment related side effects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Premenopausal women with histologically-proven, completely resected, hormone receptor-positive (defined as ER≥10% and/or PgR≥10%) stage 1, 2, and 3 invasive breast cancer who are treated with combination of anti-estrogen therapy (LHRH agonist and an aromatase inhibitor or tamoxifen)

排除标准

  • Post-menopausal women
  • Women who are on single agent endocrine therapy

结局指标

主要结局

Functional Assessment of Cancer Therapy - Breast Symptom Index (FACT-B)

时间窗: Up to three years from the time of enrolment

For global assessment of quality of life of women with breast cancer

次要结局

  • Functional Assessment of Cancer Therapy - Endocrine System (FACT-ES)(Up to three years from the time of enrolment)
  • Functional Assessment of Cancer Therapy - (FACT)-Cognitive(Up to three years from time of enrolment)
  • Treatment discontinuation rate(Up to three years from the time of enrolment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shahid Ahmed

MD

University of Saskatchewan

研究点 (3)

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