Morbidity After Diagnosis and Treatment of Breast Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00027118
First received: November 20, 2001
Last updated: February 19, 2015
Last verified: January 2015
  Purpose

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.

Condition
Breast Cancer
Shoulder
Lymphedema
Fatigue

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective (Cohort) Study to Identify Factors Affecting Morbidity Following the Diagnosis and Treatment of Patients With Breast Cancer: A Multi-Institutional Study Between the National Institutes of Health (NIH) Rehabilitation Medicine Department (RMD) and the Walter Reed National Military Medical Center (WRNMMC) Breast Care Center (BCC)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Upper limb strength [ Time Frame: 1,3,6,9, 12, 18 24 months ] [ Designated as safety issue: No ]
  • Upper limb range of motion [ Time Frame: 1,3,6,9, 12, 18 24 months ] [ Designated as safety issue: No ]
  • Upper limb volume [ Time Frame: 1,3,6,9, 12, 18 24 months ] [ Designated as safety issue: No ]
  • Arm disability questionnaire [ Time Frame: 0, 12, 18, 24 months ] [ Designated as safety issue: No ]
  • Quality of life questionnaire [ Time Frame: 0, 12, 18, 24 months ] [ Designated as safety issue: No ]
  • Physical activity questionnaire [ Time Frame: 0, 12, 18, 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: November 2001
Detailed Description:

Patients and healthy participants will undergo an interview at the beginning of the study and 1,3,6,9, 12, 18 and 24 months and answer questions about their medical history; family history; current problem and treatment; pain history; and social, physical and recreational activities. At the visit, they will also undergo an upper body physical exam by a physical therapist. Patients and the healthy participants will also fill out questionnaires about arm disability, quality of life, and physical activity at the beginning of the study and at 12, 18, and 24 months.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027118

Locations
United States, Maryland
National Naval Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Investigators
Principal Investigator: Minal Jain, R.P.T. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00027118     History of Changes
Obsolete Identifiers: NCT00513838
Other Study ID Numbers: 020045, 02-CC-0045
Study First Received: November 20, 2001
Last Updated: February 19, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Shoulder
Breast Cancer
Physical Therapy
Lymphedema
Quality of Life
Breast Cancer Surgery
Healthy Volunteer
HV
Normal Control

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Breast Diseases
Lymphatic Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on July 01, 2015