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| ID | Type | Description | Link |
|---|---|---|---|
| ASI-QOL8655 |
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Study is withdrawn due to unavailability of eligible subject population. We will request the sponsors to extend the time for enrollment.
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Other | 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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| II | Other | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling | Behavioral | • Arm II: Patients receive audio visual aids and weekly counseling sessions by the expert counselors and breast cancer survivors over 8 weeks for a total of 8-16 sessions. Patients receive written materials from the counseling group after the completion of the sessions |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2-4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Long term disease free survival | 5 years |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Prem A Nandiwada, MD | Raritan Bay Medical Center | Principal Investigator |
| Ratna Grewal, MD | American Scitech International-eCRO | Study Chair |
| Sarat Babu, MD | St. Peter's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Practicing physician in New Jersey | Englishtown | New Jersey | 07726 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| Written materials | Behavioral | • Arm I: Patients receive the support by providing existing resources. Patients receive standard written materials from the counseling group after enrolling in the study. |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005159 | Health Care Facilities Workforce and Services |
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |