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

Sponsored by:	American Scitech International
Information provided by:	American Scitech International
ClinicalTrials.gov Identifier:	NCT00712621

Purpose

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
Breast Carcinoma	Behavioral: Counseling Behavioral: Written materials	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

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

Further study details as provided by American Scitech International:

Primary Outcome Measures:

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 [ Time Frame: 2-4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Long term disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	460
Study Start Date:	April 2009
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Behavioral: 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.	Behavioral: 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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	25 Years to 85 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712621

Locations

United States, New Jersey
Practicing physician in New Jersey
Englishtown, New Jersey, United States, 07726

Sponsors and Collaborators

American Scitech International

Investigators

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

More Information

Web based electronic data capture research center; Contract Research Organization This link exits the ClinicalTrials.gov site

Responsible Party:	American Scitech International ( Dr. Ratna Grewal )
Study ID Numbers:	ASI-QOL8655, ASI-10A
Study First Received:	June 18, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00712621
Health Authority:	United States: Institutional Review Board

Keywords provided by American Scitech International:

Genetics Home Reference related topics
breast cancer
breast cancer related to depression
Condition
Stage I-IV Carcinoma of Breast

Study placed in the following topic categories:

Depression
Skin Diseases
Quality of Life
Breast Neoplasms

Depressive Disorder
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009