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Morbidity After Diagnosis and Treatment of Breast Cancer Patients

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)

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.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

326

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Maryland
      • Bethesda, Maryland, Forente stater, 20889
        • National Naval Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

  • 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Upper limb strength
Tidsramme: 1,3,6,9, 12, 18 24 months
1,3,6,9, 12, 18 24 months
Upper limb range of motion
Tidsramme: 1,3,6,9, 12, 18 24 months
1,3,6,9, 12, 18 24 months
Upper limb volume
Tidsramme: 1,3,6,9, 12, 18 24 months
1,3,6,9, 12, 18 24 months
Arm disability questionnaire
Tidsramme: 0, 12, 18, 24 months
0, 12, 18, 24 months
Quality of life questionnaire
Tidsramme: 0, 12, 18, 24 months
0, 12, 18, 24 months
Physical activity questionnaire
Tidsramme: 0, 12, 18, 24 months
0, 12, 18, 24 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Minal Jain, R.P.T., National Institutes of Health Clinical Center (CC)

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

16. november 2001

Studiet fullført

17. august 2016

Datoer for studieregistrering

Først innsendt

20. november 2001

Først innsendt som oppfylte QC-kriteriene

20. november 2001

Først lagt ut (Anslag)

21. november 2001

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. desember 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. desember 2019

Sist bekreftet

17. august 2016

Mer informasjon

Begreper knyttet til denne studien

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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