Last reviewed · How we verify
NCT00027118
Morbidity After Diagnosis and Treatment of Breast Cancer Patients
trial in Breast Cancer in 326 participants. Completed in 17 August 2016.
Quick facts
| Lead sponsor | National Institutes of Health Clinical Center (CC) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 326 |
| Start date | 16 November 2001 |
| Estimated completion | 17 August 2016 |
| Sites | 1 location across United States |
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Shoulder — all drugs for Shoulder →
- Lymphedema — all drugs for Lymphedema →
- Fatigue — all drugs for Fatigue →
Sponsor
National Institutes of Health Clinical Center (CC)
Who can join
Adults 18 to 85, any sex, with Breast Cancer or Shoulder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A Bibliometric Analysis of the Landscape of Cancer Rehabilitation Research (1992-2016).
Stout NL, Alfano CM, Belter CW, Nitkin R, et al · · 2018 · cited 93× · PMID 29982543 · DOI 10.1093/jnci/djy108
Verify or expand the search:
- PubMed search for NCT00027118
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00027118 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institutes of Health Clinical Center (CC)
- Last refreshed: 16 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00027118.
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