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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Carcinoma
- Sponsor
- American Scitech International
- Enrollment
- 460
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Withdrawn
- Last Updated
- 16 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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:
- •25 to 49 vs 50 to 85
- •Menopausal status:
- •Not specified
- •Performance status:
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
Outcomes
Primary Outcomes
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
Time Frame: 2-4 years
Secondary Outcomes
- Long term disease free survival(5 years)