Text Size

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

This study has been withdrawn prior to enrollment.
(Study is withdrawn due to unavailability of eligible subject population. We will request the sponsors to extend the time for enrollment.)
Sponsor:
Information provided by:
American Scitech International
ClinicalTrials.gov Identifier:
NCT00712621
First received: June 18, 2008
Last updated: November 20, 2009
Last verified: November 2009
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

U.S. FDA Resources

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: February 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (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.
Other Name: Quality of Life
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
Other Name: Lifestyle Counseling

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

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

No publications provided

Responsible Party: Dr. Ratna Grewal, American Scitech International
ClinicalTrials.gov Identifier: NCT00712621     History of Changes
Other Study ID Numbers: ASI-QOLII0608, ASI-QOL8655
Study First Received: June 18, 2008
Last Updated: November 20, 2009
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

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 23, 2013