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CompletedNCT00027118Updated Dec 16, 2019

Morbidity After Diagnosis and Treatment of Breast Cancer Patients

An observational study in Breast Cancer, Shoulder and Lymphedema, sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-16.

Sponsored by National Institutes of Health Clinical Center (CC) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
326
Ages
18 Years to 85 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Breast Cancer
  • Shoulder
  • Lymphedema
  • Fatigue

Keywords

  • Shoulder
  • Breast Cancer
  • Physical Therapy
  • Lymphedema
  • Quality of Life
  • Breast Cancer Surgery
  • Healthy Volunteer
  • HV
  • Normal Control
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 326 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
326 participants (actual)
06

What researchers measure

Primary outcomes

  1. Upper limb strength

    Time frame: 1,3,6,9, 12, 18 24 months

  2. Upper limb range of motion

    Time frame: 1,3,6,9, 12, 18 24 months

  3. Upper limb volume

    Time frame: 1,3,6,9, 12, 18 24 months

  4. Arm disability questionnaire

    Time frame: 0, 12, 18, 24 months

  5. Quality of life questionnaire

    Time frame: 0, 12, 18, 24 months

  6. Physical activity questionnaire

    Time frame: 0, 12, 18, 24 months

07

Study locations

1 site
  • National Naval Medical Center
    Bethesda, Maryland 20889, United States
08

References and documents

Publications

  • 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. PubMed 3847996 ↗
  • 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. PubMed 6549885 ↗
  • Carter BJ. Women's experiences of lymphedema. Oncol Nurs Forum. 1997 Jun;24(5):875-82. PubMed 9201739 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00027118
Lead sponsor
National Institutes of Health Clinical Center (CC)
Responsible party
Sponsor
First posted
Nov 21, 2001
Start date
Nov 16, 2001
Completion
Aug 17, 2016
Last update
Dec 16, 2019

Study contacts

Minal Jain, R.P.T.
principal investigator · National Institutes of Health Clinical Center (CC)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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