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

Breast Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00712621
• Other study ID #: ASI-QOLII0608
• Secondary ID: ASI-QOL8655
• Status: Withdrawn
• Phase: Phase 2
• First received: June 18, 2008
• Last updated: November 20, 2009
• Start date: February 2010
• Est. completion date: February 2014

Study information

• Verified date: November 2009
• Source: American Scitech International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 460
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Practicing physician in New Jersey	Englishtown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
American Scitech International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Long term disease free survival		5 years	Yes