Clinical trial NCT00712621: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Breast Carcinoma
Keywords: Genetics Home Reference related topics
breast cancer
breast cancer related to depression
Condition
Stage I-IV Carcinoma of Breast
Lead sponsor: American Scitech International
Sponsor class: OTHER
First posted: 2008-07-10
Enrollment: 460
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: 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
timeFrame: 2-4 years
Secondary outcomes:
measure: Long term disease free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Englishtown
country: United States
facility: Practicing physician in New Jersey
state: New Jersey
Study officials:
affiliation: Raritan Bay Medical Center
name: Prem A Nandiwada, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: American Scitech International-eCRO
name: Ratna Grewal, MD
role: STUDY_CHAIR
affiliation: St. Peter's Hospital
name: Sarat Babu, MD
role: STUDY_DIRECTOR
References: