- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00584142
Mindfulness-based Stress Reduction in Breast Cancer Recovery
14. juni 2012 opdateret af: University of South Florida
Effects of MBSR in Early Stage Breast Cancer Recovery
The purpose of this study was two-fold: (i) to assess whether MBSR favorably influences psychological status, quality of life, stress hormones, and immune status in breast cancer survivors; and (ii) to explore possible mechanisms by which MBSR may favorably influence these outcomes, in particular, through reduction in fear of breast cancer recurrence and associated perceived stress.
Both objectives were studied at the critical transition time immediately following completion of surgical, radiation and/or chemotherapy therapy for breast cancer.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Breast cancer is the most common cancer among women in the U.S. - about 1 in 8 women will develop the disease in their lifetime.
Although tremendous strides have been made in its treatment, more than 40,000 deaths will be attributed to the disease in 2005 alone.
These sobering and well-recognized risks are a major source of distress among women free from the disease, and among those who have completed treatment for new onset disease.
Regarding the latter, clinical interventions are virtually absent during the highly stressful transitional period in coming off treatment to becoming a breast cancer survivor, and no studies have tested interventions to reduce distress, particularly fear of recurrence, and improve quality of life during this time.
Therefore, we proposed to conduct a two-armed randomized wait-list controlled study on use of a mindfulness-based stress reduction (MBSR) intervention among 100 female breast cancer patients (stages 0-III) who have recently completed treatment with surgery, radiation and/or chemotherapy.
Specifically, we investigated: (i) whether MBSR favorably influences psychological status, quality of life, stress hormones, and immune status; and (ii) possible mechanisms by which MBSR may work, in particular, through a reduction in fear of breast cancer recurrence.
Both objectives were studied at the critical transition time following completion of surgical and adjuvant therapies (end of treatment to 18 months thereafter) for breast cancer.
The MBSR intervention included 6 weeks of class sessions according to the curriculum established by Kabat Zinn and Santorelli.
Analysis of covariance models are being used to assess whether change in the above-defined outcomes varies by random assignment (MBSR or wait-list), per the intention-to-treat principle.
Moreover, change (reduction) in fear of recurrence attributed to MBSR is being investigated as a mediator.
If this R21 exploratory study shows that MBSR improves patient proximal outcomes following completion of breast cancer treatment, the science will be mature enough for future large-scale evaluation of MBSR as a potential therapy to reduce long-term morbidity and mortality in breast cancer patient populations.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
84
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Florida
-
Tampa, Florida, Forenede Stater, 33612
- University of South Florida
-
-
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
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- 21 years old or older
- Diagnosed with Stage 0, I, II, or III breast cancer
- Undergone lumpectomy and completed adjuvant radiation and/or chemotherapy (end of treatment to 18 months post-treatment)
- Ability to read and speak English at the 8th grade level to respond to the survey questions
Exclusion Criteria:
- Advanced stage (IV) breast cancer
- History of mastectomy
- Current psychiatric diagnosis
- Recurrent treatment for prior breast cancer
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
|
MBSR is a clinical program that provides systematic training to promote stress reduction by self-regulating arousal to stress.
The goal of training is to teach participants to become more aware of their thoughts and feelings, and through meditation practice, to have the ability to step back from thoughts and feelings during stressful situations that contribute to increased emotional distress.
The intervention incorporates simple yoga, sitting meditation, body scan, and walking meditation in a 6-week program.
Andre navne:
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Ingen indgriben: 2
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To assess whether MBSR favorably influences psychological status (anxiety, perceived stress, depression), quality of life, and immune status (among post-treatment breast cancer survivors)
Tidsramme: 6 weeks
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6 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To explore possible mechanisms by which MBSR may favorably influence psychological status, quality of life, and/or immune status (in other words, "how" MBSR may work) (among post-treatment breast cancer survivors)
Tidsramme: 6 weeks
|
6 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Cecile A Lengacher, RN PhD, University of South Florida
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.
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. marts 2006
Primær færdiggørelse (Faktiske)
1. februar 2012
Studieafslutning (Faktiske)
1. juni 2012
Datoer for studieregistrering
Først indsendt
21. december 2007
Først indsendt, der opfyldte QC-kriterier
31. december 2007
Først opslået (Skøn)
2. januar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. juni 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. juni 2012
Sidst verificeret
1. december 2007
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R21CA109168 (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 .
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