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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


Phase 2
25 Years
85 Years
Not Enrolling
Female
Breast Carcinoma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome 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

Outcome Time Frame:

2-4 years

Safety Issue:

Yes

Principal Investigator

Prem A Nandiwada, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Raritan Bay Medical Center

Authority:

United States: Institutional Review Board

Study ID:

ASI-QOLII0608

NCT ID:

NCT00712621

Start Date:

February 2010

Completion Date:

February 2014

Related Keywords:

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

Name

Location

Practicing physician in New Jersey Englishtown, New Jersey  07726