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
- 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
- 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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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
Prem A Nandiwada, MD
Raritan Bay Medical Center
United States: Institutional Review Board
|Practicing physician in New Jersey||Englishtown, New Jersey 07726|