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
25 Years
85 Years
Female
Breast Carcinoma
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
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
Outcome Time Frame:
2-4 years
Safety Issue:
Yes
Principal Investigator
Prem A Nandiwada, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Raritan Bay Medical Center
Authority:
United States: Institutional Review Board
Study ID:
ASI-QOLII0608
NCT ID:
NCT00712621
Start Date:
February 2010
Completion Date:
February 2014
Related Keywords:
- Breast Carcinoma
- Genetics Home Reference related topics
- breast cancer
- breast cancer related to depression
- Condition
- Stage I-IV Carcinoma of Breast
- Breast Neoplasms
- Carcinoma
Name | Location |
|---|---|
| Practicing physician in New Jersey | Englishtown, New Jersey 07726 |
