Phase II Two Arm Randomized Controlled Clinical Trial to Study Quality of Life and Survival of Breast Cancer Patients After Completion of Chemotherapy or Radiation Therapy or Surgery or Any Combination Therapy in Stage I to IV Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 460
- 试验地点
- 2
- 主要终点
- Procedure: Psychological assessment and discussion on social & economic issues and medical problems related or unrelated to the therapy; quality-of-life assessment; long term survival
研究概览
简要总结
Rationale: Determining quality of life in breast cancer patient after completing chemotherapy or radiation therapy or surgical procedures or any combination therapy.
Intervention includes supportive care in terms of psychological support and moral boosting efforts by counseling breast cancer survivors which may enhance the well-being and quality of life of women who are treated with chemotherapy or radiation therapy or surgical procedures or any given combination therapy.
PURPOSE: Randomized clinical trial study to compare the effectiveness of support system and counseling of breast cancer survivors on the well-being of women, who have completed various modes of treatment of breast cancer with the subjects who have no support system.
Study Type: Quality of life and survival
Study Design: Two arm randomized controlled clinical trial to study quality of life and survival of breast cancer patients after completion of chemotherapy or radiation therapy or surgery or any combination therapy. The stages from I to IV (metastases to other sites of the body) are included.
详细描述
OBJECTIVES:
- Determine the quality of life in breast cancer patient after completing chemotherapy or radiation therapy or surgical procedures or any combination therapy in both Arms.
- Determine the effect of providing standard written materials in Arm I.
- Determine the effect of psychological support and moral boosting efforts by counseling breast cancer survivors which may enhance the well-being and quality of life of women who are treated with chemotherapy or radiation therapy or surgical procedures or any combination therapy in Arm II.
- Determine the effect of socioeconomic status on all available demographic area which is not a criteria for exclusion in both Arms.
- Determine psychosocial and mental state to measure wellness and good quality of life in both Arms.
- Determine the periodic medical care for related or unrelated problems of the disease which have a positive impact on the survival and quality of life in both Arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients
- •25 to 85 years old
- •DISEASE CHARACTERISTICS:
- •Received prior definitive treatment for stage I-IV breast cancer with or without adjuvant chemotherapy or radiation therapy or surgical therapy or any combination therapy.
- •3 to 18 months since completion therapy.
- •PATIENT CHARACTERISTICS:
- •25 to 49 vs 50 to 85
- •Menopausal status:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •CBC in normal range:
- •Hemoglobin - 10 g/dl
- •Blood Glucose is twofold above the normal range
- •Hepatic profile is twofold above the normal range:
- •Bilirubin,total
- •Protein (Albumin, Globulin)
- •Renal tests are twofold above the normal range:
- •Creatinine clearance 24 hours
- •Creatinine level
- •No current psychiatric diagnosis
- •Mini Mental Status Examination
- •No signs and symptoms MDD
- •Anxiety disorder
- •Post Traumatic Syndrome Disorder
- •Status of Therapy:
- •Chemotherapy:
- •Completed
- •Endocrine therapy:
- •Completed
- •Radiotherapy:
- •Completed
- •Completed at least three months before the start of the study
排除标准
- •Age below 25 and above 85
- •Subject with breast carcinoma in therapy
- •Any current mental illness
- •Hepatic enzymes are more than twofold from the normal range
- •Renal impairment is more than twofold from the normal range
- •Hemoglobin is less than 10 g/dl
- •CBC results are below normal range
结局指标
主要结局
Procedure: Psychological assessment and discussion on social & economic issues and medical problems related or unrelated to the therapy; quality-of-life assessment; long term survival
时间窗: 2-4 years
次要结局
- Long term disease free survival(5 years)