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Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer II) (BEAT)

13. oktober 2021 opdateret af: Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham

Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer Study II)

The purpose of the study is to compare the effects of one exercise/counseling protocol with usual care on long term exercise adherence and on changes in health related outcomes after breast cancer diagnosis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Physical activity may improve quality of life, the control of comorbid conditions, and weight management while reducing breast cancer recurrence and mortality among breast cancer survivors. Unfortunately, most breast cancer survivors do not engage in regular physical activity. In fact, breast cancer survivors are often less active after a diagnosis and may not return to pre-diagnosis activity levels. Therefore, we conducted a pilot study, "BEAT Cancer", to test a specifically defined physical activity behavior change intervention to increase physical activity for breast cancer survivors. The pilot study showed significant improvement in both physical activity and health outcomes for the study participants after the intervention. Importantly, the pilot intervention resulted in changes in physical activity and social cognitive theory constructs, such as the participants feeling more confident in their ability to exercise. The positive results enhance our potential for testing mechanisms that encourage physical activity behavior change in breast cancer survivors. The current study is a follow-up to confirm program effectiveness at 3 months and to test sustainability of results at 3-12 months. We propose a multi-center, randomized controlled trial enrolling 356 breast cancer survivors with the following study aims:

  1. To compare the effects of the 3-month BEAT Cancer physical activity behavior change intervention to usual care on short and longer term physical activity adherence among breast cancer survivors. We hypothesize that, compared with usual care, the intervention will result in a significant increase in physical activity after the intervention that will be maintained up to 12 months after baseline.
  2. To better understand the reasons why breast cancer patients change their physical activity behavior, we will compare the effects of the BEAT Cancer physical activity behavior change intervention to usual care on social cognitive factors to see if such changes contribute to physical activity behavior change. We hypothesize that, compared with usual care, the intervention will result in significant improvements in social cognitive factors which lead to changes in physical activity behavior.
  3. We also aim to compare the short and longer term health effects of the BEAT Cancer physical activity behavior change intervention when compared with usual care. We hypothesize that, compared with usual care, the intervention will result in significant improvements in fitness, muscle strength, waist-to-hip ratio, quality of life, fatigue, and sleep quality, while reducing joint dysfunction.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

374

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham
    • Illinois
      • Champaign, Illinois, Forenede Stater, 61801
        • University of Illinois
      • Springfield, Illinois, Forenede Stater, 62702
        • Southern Illinois University School of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Female breast cancer patients between the ages of 18 and 70 years of age with a diagnosis of ductal carcinoma in situ (DCIS) or Stage I, II, or IIIA breast cancer and who are not currently receiving (and do not plan to receive during the duration of the study) chemotherapy or radiation therapy. The participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc. The upper age limit of 70 years was chosen to reduce the likelihood of adverse events or study drop-out due to increasing comorbidities (e.g., cardiovascular disease) that occur with age.
  • If the patient has undergone a surgical procedure, enrollment will be delayed until ≥ 8 weeks post-procedure.
  • English speaking.
  • Medical clearance for participation provided by primary care physician or oncologist.
  • Participating, on average, in no more than 60 minutes of moderate physical activity or no more than 30 minutes of vigorous activity per week during the past six months.

Exclusion Criteria:

  • Diagnosis of dementia or organic brain syndrome.
  • Medical, psychological, or social characteristic that would interfere with ability to fully participate in program activities and assessments (e.g., psychosis, schizophrenia, etc.).
  • Contraindication to participation in a regular physical activity program.
  • Metastatic or recurrent disease.
  • Inability to ambulate.
  • Anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery).
  • Planned travel that would interfere with scheduled study sessions (no travel in the 1st 4 months and no travel ≥ 1 week in the last 8 weeks of the intervention).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1: exercise with 2 counseling types
Patients will participate in 12 individual exercise sessions with an exercise specialist; plus attend 6 discussion group sessions with a trained facilitator; plus 3 face-to-face, individual counseling sessions with an exercise specialist
Adfærdsmæssigt: Experimental 1: exercise with 2 counseling types
Patients will participate in 12 individual exercise sessions with an exercise specialist which will include stretching exercises and aerobic treadmill walking; plus attend 6 discussion group sessions with a trained facilitator; plus 3 face-to-face, individual counseling sessions with an exercise specialist
Andet: 2. Usual Care - written materials
Patients will receive written materials about exercise for cancer survivors
Andet: Usual Care - written materials
Patients will receive written materials about exercise for cancer survivors

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change in physical activity
Tidsramme: baseline to 3 months
Physical activity will be measured with accelerometers and self-report questionnaire. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).
baseline to 3 months
change in physical activity
Tidsramme: 3 mos to 6 months
Physical activity will be measured with accelerometers and self-report questionnaire. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).
3 mos to 6 months
change in physical activity
Tidsramme: 6 months to 12 months
Physical activity will be measured with accelerometers and self-report questionnaire. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).
6 months to 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change in treadmill fitness
Tidsramme: baseline, 3 months, 6 months, 12 months
Treadmill fitness will be measured by sub-maximal fitness test. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).
baseline, 3 months, 6 months, 12 months
change in waist-to-hip ratio
Tidsramme: baseline, 3 months, 6 months, 12 months
Waist-to-hip ratio will be measured with a tape measure. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).
baseline, 3 months, 6 months, 12 months
change in 3-day dietary intake
Tidsramme: baseline, 3 months, 6 months, 12 months
3-day dietary intake will be measured by questionnaire. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).
baseline, 3 months, 6 months, 12 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Energy expenditure (doubly labeled water)
Tidsramme: baseline, 3 months, and 6 months
Doubly labeled water results will be used to determine reliability of accelerometer measures as part of an NCI funded supplement.
baseline, 3 months, and 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Alabama at Birmingham

Samarbejdspartnere

National Cancer Institute (NCI)
National Institutes of Health (NIH)
University of Illinois at Urbana-Champaign
Southern Illinois University

Efterforskere

  • Ledende efterforsker: Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2009

Primær færdiggørelse (Faktiske)

1. marts 2017

Studieafslutning (Faktiske)

1. marts 2017

Datoer for studieregistrering

Først indsendt

26. juni 2009

Først indsendt, der opfyldte QC-kriterier

26. juni 2009

Først opslået (Skøn)

29. juni 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ROG-SCCI 09-003-2
  • 3R01CA136859-02S1 (U.S. NIH-bevilling/kontrakt)
  • U01CA136859 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Brystkræft

Kliniske forsøg med Experimental 1: exercise with 2 counseling types

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner