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

NCT00712621 | Withdrawn Phase 2

• 2 other identifiers: ASI-QOLII0608ASI-QOL8655
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Long term disease free survival

  5 years

Study Arms (2)

I

OTHER

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

II

OTHER

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

Interventions

Counseling BEHAVIORAL

• 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

Also known as: Lifestyle Counseling

II

Written materials BEHAVIORAL

• Arm I: Patients receive the support by providing existing resources. Patients receive standard written materials from the counseling group after enrolling in the study.

Also known as: Quality of Life

I

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer patients
• 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.
• to 18 months since completion therapy.
• PATIENT CHARACTERISTICS:
• Age:
• to 49 vs 50 to 85
• Sex:
• Female
• Menopausal status:
• Not specified
• Performance status:
• Not specified
• Life expectancy:

You may not qualify if:

• 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

Sponsors & Collaborators

• American Scitech International: lead

Study Sites (1)

Practicing physician in New Jersey

Englishtown, New Jersey, 07726, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Disease

Interventions

Counseling; Quality of Life

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Prem A Nandiwada, MD

  Raritan Bay Medical Center

  PRINCIPAL INVESTIGATOR

• Ratna Grewal, MD

  American Scitech International-eCRO

  STUDY CHAIR

• Sarat Babu, MD

  St. Peter's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: July 10, 2008
• Study Start: February 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 24, 2009

Record last verified: 2009-11

Locations

US (1)