Determining Quality of Life in Breast Cancer Patient After Completing Radiation,Chemotherapy,Surgery or Combination
NCT ID: NCT00712621
Last Updated: 2009-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
460 participants
INTERVENTIONAL
2010-02-28
2014-02-28
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Written materials
• Arm I: Patients receive the support by providing existing resources. Patients receive standard written materials from the counseling group after enrolling in the study.
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.
Counseling
• 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
Interventions
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Counseling
• 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
Written materials
• Arm I: Patients receive the support by providing existing resources. Patients receive standard written materials from the counseling group after enrolling in the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
85 Years
FEMALE
No
Sponsors
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American Scitech International
OTHER
Responsible Party
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American Scitech International
Principal Investigators
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Prem A Nandiwada, MD
Role: PRINCIPAL_INVESTIGATOR
Raritan Bay Medical Center
Ratna Grewal, MD
Role: STUDY_CHAIR
American Scitech International-eCRO
Sarat Babu, MD
Role: STUDY_DIRECTOR
St. Peter's Hospital
Locations
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Practicing physician in New Jersey
Englishtown, New Jersey, United States
Countries
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Other Identifiers
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ASI-QOL8655
Identifier Type: -
Identifier Source: secondary_id
ASI-QOLII0608
Identifier Type: -
Identifier Source: org_study_id