Determining Quality of Life in Breast Cancer Patient After Completing Radiation,Chemotherapy,Surgery or Combination

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Carcinoma

Intervention / Treatment
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* Behavioral: Counseling
* Behavioral: Written materials


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: I<br>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. | Behavioral: Written materials<br>* • Arm I: Patients receive the support by providing existing resources. Patients receive standard written materials from the counseling group after enrolling in the study.<br>* Other names: Quality of Life;|
| Other: II<br>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. | Behavioral: Counseling<br>* • 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<br>* Other names: Lifestyle Counseling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term disease free survival |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genetics Home Reference related topics, breast cancer, breast cancer related to depression, Condition, Stage I-IV Carcinoma of Breast