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Sponsored by: |
American Scitech International |
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Information provided by: | American Scitech International |
ClinicalTrials.gov Identifier: | NCT00712621 |
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.
Condition | Intervention | Phase |
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Breast Carcinoma |
Behavioral: Counseling Behavioral: Written materials |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Parallel Assignment |
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 |
Estimated Enrollment: | 460 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | July 2014 |
Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I
OUTLINE: This is a randomized, multicenter study. Patients are selected according to age ( 25 to 49 vs 50 to 85), time since initial completion of therapy (3 to 18 months), and are separated in two groups. Arm I: Quality of life is assessed at baseline and at 3 and 6 months.
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Behavioral: Written materials
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II
OUTLINE: This is a randomized, multicenter study. Patients are selected according to age ( 25 to 49 vs 50 to 85), time since initial completion of therapy (3 to 18 months), and are separated in two groups. Arm II: Quality of life is assessed at baseline and at 3 and 6 months.
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Behavioral: Counseling
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OBJECTIVES:
Ages Eligible for Study: | 25 Years to 85 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
Status of Therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Exclusion Criteria:
United States, New Jersey | |
Practicing physician in New Jersey | |
Englishtown, New Jersey, United States, 07726 |
Principal Investigator: | Prem A Nandiwada, MD | Raritan Bay Medical Center |
Study Chair: | Ratna Grewal, MD | American Scitech International-eCRO |
Study Director: | Sarat Babu, MD | St. Peter's Hospital |
Responsible Party: | American Scitech International ( Dr. Ratna Grewal ) |
Study ID Numbers: | ASI-QOLII0608, ASI-QOL8655 |
Study First Received: | June 18, 2008 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00712621 History of Changes |
Health Authority: | United States: Institutional Review Board |
Genetics Home Reference related topics breast cancer breast cancer related to depression Condition Stage I-IV Carcinoma of Breast |
Depression Skin Diseases Quality of Life Breast Neoplasms |
Depressive Disorder Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Skin Diseases |
Breast Neoplasms Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |