Yoga for Aromatase Inhibitor-associated Joint Pain
1. juli 2016 oppdatert av: H. Lee Moffitt Cancer Center and Research Institute
Evaluating Yoga for Aromatase Inhibitor-associated Joint Pain in Women With Breast Cancer: A Pilot Study
The purpose of this study is to determine whether it might be practical and useful to investigate the effectiveness of yoga classes in relieving joint pain associated with the use of a class of medications known as aromatase inhibitors.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The study uses a single-arm design.
All study participants will be assigned to an intervention condition in which they participate in group Iyengar yoga classes for 90 minutes twice per week for 12 weeks (total of 24 classes).
Study outcomes are assessed: 1) following recruitment but prior to the first yoga class; and 2) within two weeks post-intervention (follow-up).
Additionally, a brief assessment of pain will be conducted four weeks and eight weeks after the start of yoga classes.
Studietype
Intervensjonell
Registrering (Faktiske)
16
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Florida
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Tampa, Florida, Forente stater, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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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 og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Have been diagnosed with stage 0-III breast cancer
- Have completed local and/or adjuvant breast cancer therapy (with the exception of hormonal therapy) at least one month previously
- Are post-menopausal defined as defined as no menses in the past 12 months
- Are currently prescribed an aromatase inhibitor (AI) medication (anastrozole, letrozole, or exemestane) by a Moffitt-affiliated physician
- Report joint pain that started or worsened after initiation of AI medication
- Report worst pain score > 4 in the preceding week on an 11-point (0-10) numeric rating scale
Exclusion Criteria:
- Have been diagnosed with another form of cancer (except nonmelanoma skin cancer) in the last five years
- Have uncontrolled cardiac disease, pulmonary disease, or infectious disease
- Have physical symptoms or conditions that could make yoga unsafe (i.e., neck injuries, dizziness, shortness of breath, chest pain, or severe nausea)
- Have a body mass index (BMI) > 40 kg/m^2 (based on difficulties severly obese individuals may have with engaging in Iyengar yoga poses)
- Have joint pain attributed to inflammatory arthritic conditions (i.e., rheumatoid arthritis, gout, pseudo-gout) per medical record or patient history
- Had surgery within the past 3 months
- Had injections of medication within the last 3 months to joint(s) currently painful
- Are currently using corticosteroids or opioid medications
- Are currently attending yoga classes
- Do not speak or read standard English
- Are scheduled or are planning to discontinue AI medication in the next 16 weeks
- Do not have sufficient access to the Internet to complete study assessments
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Intervention Condition
Questionnaires and yoga classes. Group will attend a series of 90-minute yoga classes twice a week for 12 weeks. |
Participants will be asked to complete a set of questionnaires about their health and well-being on two occasions (baseline and follow-up).
Each set of questionnaires will take about 45 minutes to complete.
Iyengar yoga is a traditional form of Hatha yoga that has been used previously to address quality of life issues in women with breast cancer.
Iyengar yoga classes for 90 minutes twice per week for 12 weeks (total of 24 classes).
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of Study Enrollment
Tidsramme: 24 months
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Acceptability of the proposed study to potential participants.
The study will be considered acceptable if 50% or more of eligible participants agree to participate.
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24 months
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Rate of Study Completion
Tidsramme: Up to 24 weeks per participant
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Feasibility of the proposed study assessment and intervention methods.
The study methods will be considered feasible if 70% or more of consented participants complete both the baseline and follow-up assessments and attend an average of 70% or more of scheduled yoga classes.
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Up to 24 weeks per participant
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Occurrence of Reduced Pain Severity
Tidsramme: Up to 24 weeks per participant
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Potential efficacy of the intervention in relieving AI medication-associated joint pain.
The intervention will be considered potentially efficacious in relieving AI medication-associated joint pain if comparisons of pre- and post-intervention means for one or more measures of pain severity yield an effect size >/= 0.3 consistent with pain reduction.
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Up to 24 weeks per participant
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Occurrence of Relief from Other Side Effects
Tidsramme: Up to 24 weeks per participant
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Potential efficacy of the intervention in relieving other reported side effects of AI medication (i.e., fatigue, hot flashes, sleep problems, and depressive symptoms).
The intervention will be considered potentially efficacious in relieving other known side effects if comparisons of pre- and post-intervention means yield an effect size >/= 0.3 consistent with side effect reduction.
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Up to 24 weeks per participant
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Paul Jacobsen, Ph.D., H. Lee Moffitt Cancer Center and Research Institute
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.
Hjelpsomme linker
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
1. september 2013
Primær fullføring (Faktiske)
1. mars 2015
Studiet fullført (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først innsendt
24. september 2013
Først innsendt som oppfylte QC-kriteriene
24. september 2013
Først lagt ut (Anslag)
27. september 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
4. juli 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juli 2016
Sist bekreftet
1. juli 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MCC-17592
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