- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01230671
The Physical and Psychological Benefits of Yoga and Breast Cancer
The Physical and Psychological Benefits of Yoga in Patients With Breast Cancer: A Feasibility Study
Studieoversigt
Detaljeret beskrivelse
Proposed Intervention:
1-hour hatha yoga classes, once a week for a 12-week period. One class will be offered in French, another in English. The class will begin with approximately 10 minutes of pranayama (breathing exercises) and meditation, followed by 30 minutes of yoga poses and ending with 10 minutes of sivasana (rest period.) The first couple of classes in the 12 week series will begin with restorative postures and will gradually progress to more gentle exercises. If health permits, the last couple of classes will involve some strengthening poses. A small portion of the class will work with the physical body in general and there will be a specific emphasis on the physical difficulties faced by most breast cancer patients, i.e. neck, chest, shoulders arms and hands.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Quebec
-
Montreal, Quebec, Canada, H3G 1A4
- Cedar's Breast Clinic, Royal Victoria Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Ages between 18-70
- Stage I to II breast cancer
- Minimum of 6 weeks Post Operative status
Exclusion Criteria:
- Previous/Current psychiatric history
- Concurrently involved in a yoga program
- Inability to undergo yoga training secondary to physical/health limitations outlined by the treating team
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Yoga
Patients in this arm will receive yoga therapy
|
A 12 week yoga session will be offered to women with breast cancer.
|
|
Placebo komparator: No yoga
Patients will not have yoga in this arm
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Range of motion of the shoulders
Tidsramme: 12 weeks
|
The range of motion of the shoulders will be measured before and after the 12 week session and then compared.
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Anxiety
Tidsramme: 12 weeks
|
The participants will fill in questionnaires (HADS and the Distress Thermometer) before and after the 12 week session and the results will be compared.
|
12 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 10-059-PSY
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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