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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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