- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00584142
Mindfulness-based Stress Reduction in Breast Cancer Recovery
14 juni 2012 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
84
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Florida
-
Tampa, Florida, Förenta staterna, 33612
- University of South Florida
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
Andra namn:
|
Inget ingripande: 2
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
To assess whether MBSR favorably influences psychological status (anxiety, perceived stress, depression), quality of life, and immune status (among post-treatment breast cancer survivors)
Tidsram: 6 weeks
|
6 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
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)
Tidsram: 6 weeks
|
6 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Cecile A Lengacher, RN PhD, University of South Florida
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2006
Primärt slutförande (Faktisk)
1 februari 2012
Avslutad studie (Faktisk)
1 juni 2012
Studieregistreringsdatum
Först inskickad
21 december 2007
Först inskickad som uppfyllde QC-kriterierna
31 december 2007
Första postat (Uppskatta)
2 januari 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
18 juni 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 juni 2012
Senast verifierad
1 december 2007
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R21CA109168 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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