Yoga for Aromatase Inhibitor-associated Joint Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01951976|
Recruitment Status : Completed
First Posted : September 27, 2013
Last Update Posted : July 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: Questionnaires Other: Yoga Classes||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluating Yoga for Aromatase Inhibitor-associated Joint Pain in Women With Breast Cancer: A Pilot Study|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||June 2016|
Experimental: 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.
Other: Yoga Classes
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).
- Rate of Study Enrollment [ Time Frame: 24 months ]Acceptability of the proposed study to potential participants. The study will be considered acceptable if 50% or more of eligible participants agree to participate.
- Rate of Study Completion [ Time Frame: Up to 24 weeks per participant ]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.
- Occurrence of Reduced Pain Severity [ Time Frame: Up to 24 weeks per participant ]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.
- Occurrence of Relief from Other Side Effects [ Time Frame: Up to 24 weeks per participant ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951976
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Paul Jacobsen, Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|