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

Primary Purpose

Breast Carcinoma

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Counseling
Written materials
Sponsored by
American Scitech International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Carcinoma focused on measuring Genetics Home Reference related topics, breast cancer, breast cancer related to depression, Condition, Stage I-IV Carcinoma of Breast

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Practicing physician in New Jersey

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

I

II

Arm Description

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.

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.

Outcomes

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

Secondary Outcome Measures

Long term disease free survival

Full Information

First Posted
June 18, 2008
Last Updated
November 20, 2009
Sponsor
American Scitech International
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1. Study Identification

Unique Protocol Identification Number
NCT00712621
Brief Title
Determining Quality of Life in Breast Cancer Patient After Completing Radiation,Chemotherapy,Surgery or Combination
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Withdrawn
Why Stopped
Study is withdrawn due to unavailability of eligible subject population. We will request the sponsors to extend the time for enrollment.
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
American Scitech International

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma
Keywords
Genetics Home Reference related topics, breast cancer, breast cancer related to depression, Condition, Stage I-IV Carcinoma of Breast

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Other
Arm Description
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.
Arm Title
II
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Other Intervention Name(s)
Lifestyle Counseling
Intervention Description
• 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
Intervention Type
Behavioral
Intervention Name(s)
Written materials
Other Intervention Name(s)
Quality of Life
Intervention Description
• Arm I: Patients receive the support by providing existing resources. Patients receive standard written materials from the counseling group after enrolling in the study.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Long term disease free survival
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prem A Nandiwada, MD
Organizational Affiliation
Raritan Bay Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ratna Grewal, MD
Organizational Affiliation
American Scitech International-eCRO
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sarat Babu, MD
Organizational Affiliation
St. Peter's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Practicing physician in New Jersey
City
Englishtown
State/Province
New Jersey
ZIP/Postal Code
07726
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.americanscitech.com
Description
Web based electronic data capture research center; Contract Research Organization

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

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