NCT00027105

Brief Summary

This study will examine the frequency and severity of problems in women with breast cancer during the first year after 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. Participants will be drawn from patients referred to the National Naval Medical Center for diagnosis and treatment during 2000-20001. Participants will be interviewed and their medical records reviewed for past medical history, history of the present illness and social and recreational history. They will be seen five times over a 1-year period (initial visit and at 3, 6, 9, and 12 months), for 30-minute visits, which will include the following:
  • Interview about past medical history and present illness, social and recreational activities, functional independence at work and during activities of daily living.
  • Complete health survey and upper limb disability questionnaire; physical activity questionnaire to be completed at 6 and 12 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, an upper limb lift test, and measures of upper limb volume and girth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2001

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2001

Completed
14.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2016

Completed
Last Updated

December 12, 2019

Status Verified

August 17, 2016

First QC Date

November 20, 2001

Last Update Submit

December 11, 2019

Conditions

Breast CancerLymphedemaPhysical TherapyShoulder

Keywords

FatigueShoulder functionLymphedemaBreast CancerBreast Cancer SurgeryQuality of Life

Outcome Measures

Primary Outcomes (3)

  • Upper limb strength

    1,3,6,9,12,60 months

  • Range of motion

    1,3,6,9,12,60 month

  • Upper limb volume

    1,3,6,9,12,60 month

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 2000-2001, are eligible to participate in the study.
  • Subjects must be over age 18. This age ensures they are 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 five follow-up visits of 30 minutes in duration during the next year.

You may not qualify if:

  • Subject's medical records are unavailable and clinical examination forms are incomplete.
  • Subjects choose not to participate in the study.
  • Subjects are unable to complete the questionnaires.
  • Subjects are under age 18.
  • Men are not excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, 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: 3847996BACKGROUND

  • 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: 6549885BACKGROUND

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

    PMID: 9201739BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsLymphedemaFatigue

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesSigns and SymptomsPathological 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 12, 2019

Record last verified: 2016-08-17

Locations

US(1)