Breast Carcinoma Clinical Trial
Official title:
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
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.
Status | Withdrawn |
Enrollment | 460 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 85 Years |
Eligibility |
Inclusion Criteria: - 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: Age: - 25 to 49 vs 50 to 85 Sex: - Female 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: - Hepatic profile is twofold above the normal range: - AST/ALT - Bilirubin,total - Protein (Albumin, Globulin) Renal: - Renal tests are twofold above the normal range: - Creatinine clearance 24 hours - BUN - Creatinine level Other: - 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 Surgery: - Completed at least three months before the start of the study Exclusion Criteria: - 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Practicing physician in New Jersey | Englishtown | New Jersey |
Lead Sponsor | Collaborator |
---|---|
American Scitech International |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 2-4 years | Yes | |
Secondary | Long term disease free survival | 5 years | Yes |
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