Morbidity After Diagnosis and Treatment of Breast Cancer Patients

NCT00027118 | Completed

• 2 other identifiers: 02004502-CC-0045
• Study Type: observational
• Target: 326
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the frequency and severity of problems in women with breast cancer for 2 years following initial medical treatment, including:

• Physical impairments, such as loss of strength or flexibility, increased weight and swelling.
• Symptom distress, such as pain, fatigue and weakness.
• Functional limitations and disabilities, such as loss of independence in activities of daily living (e.g., grooming, bathing, dressing, driving a car), work and social and recreational activities. It will identify factors associated with these problems and try to determine their relationship to them. Patients 18 years of age and older with stage I, II, III or IV breast cancer may be eligible for this study. Women who have a breast biopsy negative for cancer will also be enrolled as control subjects. Participants will be drawn from patients referred to the National Naval Medical Center for diagnosis and treatment during 2001-2003. Participants will be evaluated over a 2-year period during an initial baseline visit (before medical treatment or biopsy) and follow-up visits at 1, 3, 6, 12, 18 and 24 months following procedures:
• Interview about past medical history and present illness, social and recreational activities, functional independence at work and during activities of daily living.
• Completion of questionnaires including health survey, upper limb disability questionnaire, and physical activity questionnaire. (Questionnaires are completed only at baseline and 12 and 24 months after medical treatment begins.) The questionnaires take about 30 to 40 minutes to complete.
• Upper body examination, including pain measurement using a 10-point scale, active and passive range of motion measures, manual muscle testing measures using a 10-point scale, timed upper limb lift test, and measures of upper limb volume and girth.

Conditions

Breast Cancer; Shoulder; Lymphedema; Fatigue

Keywords

Shoulder; Breast Cancer; Physical Therapy; Lymphedema; Quality of Life; Breast Cancer Surgery; Healthy Volunteer; HV; Normal Control

Outcome Measures

Primary Outcomes (6)

• Upper limb strength

  1,3,6,9, 12, 18 24 months

• Upper limb range of motion

  1,3,6,9, 12, 18 24 months

• Upper limb volume

  1,3,6,9, 12, 18 24 months

• Arm disability questionnaire

  0, 12, 18, 24 months

• Quality of life questionnaire

  0, 12, 18, 24 months

• Physical activity questionnaire

  0, 12, 18, 24 months

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Population/Subjects: Individuals with breast cancer are identified among the patient population at National Naval Medical Center (NNMC). Patients referred to the NNMC Breast Care Center) NNMC-BCC for diagnosis and management (surgical treatment and radiation treatment or chemotherapy) of histologically established breast cancer (stage I, II, III, or IV) during 2001-2003, are eligible to participate in the study.
• Healthy female individuals will be controls.
• Subjects must be over 18 years of age and post-puberty as breast cancer does not occur prior to puberty; and been seen pre-surgical or medical intervention for baseline measurements and agree to participate in six follow-up visits of 30-45 minutes in duration during the next two-years.

You may not qualify if:

• Subject chooses to not participate in the study.
• Subjects are unable to complete the clinical examination tests.
• Subjects are unable to complete the questionnaires/surveys.
• Subjects are under age 18.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Naval Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (3)

• King KB, Nail LM, Kreamer K, Strohl RA, Johnson JE. Patients' descriptions of the experience of receiving radiation therapy. Oncol Nurs Forum. 1985 Jul-Aug;12(4):55-61. No abstract available.

  PMID: 3847996 BACKGROUND

• Meyerowitz BE, Watkins IK, Sparks FC. Quality of life for breast cancer patients receiving adjuvant chemotherapy. Am J Nurs. 1983 Feb;83(2):232-5. No abstract available.

  PMID: 6549885 BACKGROUND

• Carter BJ. Women's experiences of lymphedema. Oncol Nurs Forum. 1997 Jun;24(5):875-82.

  PMID: 9201739 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema; Fatigue

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Minal Jain, R.P.T.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2001
• First Posted: November 21, 2001
• Study Start: November 16, 2001
• Study Completion: August 17, 2016
• Last Updated: December 16, 2019

Record last verified: 2016-08-17

Locations

US (1)