- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02442635
Yoga During Chemotherapy Study
12 november 2019 uppdaterad av: University of California, San Francisco
Developing a Yoga Intervention During Cancer Chemotherapy
This proposal aims to expand non-pharmacologic options for the control of symptoms during chemotherapy using yoga practices.
It is particularly focused on sleep disturbance with a secondary focus on fatigue.
Studieöversikt
Detaljerad beskrivning
Sleep disturbance is among the most common symptoms experienced by cancer patients, occurs in up to 80% of patients during chemotherapy, and results in serious impairments in quality of life.
Although pharmacologic therapies improve sleep disturbance, they have numerous side effects, problems with tolerance and dependence, and are not well studied in oncology patients.
While non-pharmacologic therapies may decrease sleep disturbance, the current level of evidence on their efficacy is insufficient.
Fatigue occurs in up to 95% of those receiving chemotherapy, and results in major impairments in functioning and quality of life.
Despite its significance, few effective treatments currently exist for fatigue.
Prior studies suggest that yoga may be helpful for sleep disturbance and fatigue, but these studies have limitations.
An important challenge in yoga research is that it is typically a multi-modality practice that can include physical postures, breathing practices, and/or meditation components.
Prior studies have not adequately addressed the effects of individual components.
Therefore, key questions remain unanswered about the most effective elements of yoga; how to best combine them for particular problems such as chemotherapy symptoms; and optimal dosing.
The current study will address these gaps in the literature and perform key developmental steps to prepare for a large randomized, controlled trial (RCT).
It builds on preliminary work in which yoga breathing practices during chemotherapy were found to improve sleep disturbance, showed trends toward improvements in fatigue, and were feasible to implement in patients undergoing chemotherapy.
Using a mixed-methods approach to evaluate each intervention component, the investigators will pursue three closely interlinked steps in cancer patients receiving chemotherapy.
In Aim 1 (n=10), the investigators will manualize an individualized approach to the yoga breathing intervention and iteratively refine it to insure feasibility and acceptability.
In Aim 2 (n=20), the investigators will manualize a yoga posture intervention, evaluating both restorative/static poses and flowing poses, and perform iterative refinement to test feasibility and acceptability.
In Aim 3 (n=70), the investigators will assess the final multi-modality yoga intervention to select final intervention elements and delivery methods for testing in a planned future RCT.
This proposal will help to improve the treatment of debilitating cancer associated symptoms and advance approaches to developing therapeutic yoga intervention trials.
Studietyp
Interventionell
Inskrivning (Faktisk)
73
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
San Francisco, California, Förenta staterna, 94110
- UCSF
-
-
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
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Age 18 and older
- Have a Karnofsky Performance Status Score of 60 or above
- Diagnosed with any cancer except acute leukemia
- Self-reported poor quality of sleep
- Receiving Chemotherapy
- Able to read, write, and understand English
- Ability to give informed consent
Exclusion Criteria:
- Diagnosed with brain metastasis
- Diagnosed with severe Chronic Obstructive Pulmonary Disease (COPD) or emphysema
- Have New York Heart Association class II or greater congestive heart failure
- Requiring chronic home oxygen therapy
- Diagnosed with a sleep disorder (e.g., sleep apnea or narcolepsy)
- Have received more than 3 prior chemotherapy regimens
- Receiving radiation therapy
- Has a less than 6 month life expectancy
- Regular yoga practice within the last 2 months
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: Condition 1
Yoga Breathing
|
Yoga breathing and postures; After this initial 3 arm experiment, yoga breathing and postures will be studied in combination.
|
Experimentell: Condition 2
Static Yoga
|
Yoga breathing and postures; After this initial 3 arm experiment, yoga breathing and postures will be studied in combination.
|
Experimentell: Condition 3
Flowing Yoga
|
Yoga breathing and postures; After this initial 3 arm experiment, yoga breathing and postures will be studied in combination.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Sleep Disturbance as measured by the General Sleep Disturbance Scale
Tidsram: 6 weeks
|
6 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Fatigue as measured by the Lee Fatigue Scale
Tidsram: 6 weeks
|
6 weeks
|
Andra resultatmått
Resultatmått |
Tidsram |
---|---|
Quality of Life as measured by the Multidimensional Quality of Life Scale--Cancer
Tidsram: 6 weeks
|
6 weeks
|
Depressive Symptoms as measured by the CES-D
Tidsram: 6 weeks
|
6 weeks
|
Anxiety as measured by the Spielberger State Anxiety Inventory
Tidsram: 6 weeks
|
6 weeks
|
Pain as measured by the modified Brief Pain Inventory
Tidsram: 6 weeks
|
6 weeks
|
Hot Flashes as measured by the Hot Flash Related Daily Interference Scale
Tidsram: 6 weeks
|
6 weeks
|
Mindfulness as measured by the Five Facet Mindfulness Questionnaire
Tidsram: 6 weeks
|
6 weeks
|
Body Awareness as measured by the Multidimensional Assessment of Interoceptive Awareness
Tidsram: 6 weeks
|
6 weeks
|
Coping and Self Efficacy as measured by the Coping and Self Efficacy Scale
Tidsram: 6 weeks
|
6 weeks
|
Social Support as measured by single items on social support
Tidsram: 6 weeks
|
6 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Anand Dhruva, MD, University of California, San Francisco
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 maj 2015
Primärt slutförande (Faktisk)
1 oktober 2019
Avslutad studie (Faktisk)
1 oktober 2019
Studieregistreringsdatum
Först inskickad
30 april 2015
Först inskickad som uppfyllde QC-kriterierna
8 maj 2015
Första postat (Uppskatta)
13 maj 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 november 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 november 2019
Senast verifierad
1 november 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 15-15691
- R34AT007935 (U.S.S. NIH-anslag/kontrakt)
- 15991 (Annan identifierare: University of California, San Francisco)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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