NCT01927081|Completed
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Sponsor study identifier
interventional
65
1 country
1
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 20, 2017
Actual (reported)Study Completion
November 20, 2017
Actual (reported)The purpose of this research study is to evaluate whether self-management discussion groups are helpful for women with advanced breast cancer who are experiencing pain. The study is looking at the usefulness of two different types of discussion groups, one of which also includes gentle exercise.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 20, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 16, 2013
Actual (reported)August 22, 2013
Actual (reported)September 2014
Date type not reportedThis date has not been verified as actual or estimated.
November 20, 2017
Actual (reported)November 20, 2017
Actual (reported)Feasibility
Feasibility will be indicated by our ability to meet accrual goals, and by at least 70% of patients attending ≥4 of 8 sessions and providing post-test assessments
36 months
Acceptability
Acceptability will be assessed via participant ratings on a standardized measure of treatment effectiveness/satisfaction, supplemented by exit interview
36 months
Change in pain
study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Change in fatigue
study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Change in sleep disturbance
study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Change in Psychological distress
study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Change in functional capacity
study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Eight weekly group sessions in which participants will engage in discussions regarding issues related to coping with advanced cancer and pain
Eight weekly group sessions in which participants will engage in discussions regarding issues related to coping with advanced cancer and pain and learn gentle exercise and breathing techniques
Participants engage in discussions regarding issues related to coping with advanced cancer and pain
Patients learn gentle exercise and breathing techniques
Duke University Medical Center
Durham, North Carolina, 27708, United States
Carson JW, Carson KM, Olsen MK, Sanders L, Porter LS. Mindful Yoga for women with metastatic breast cancer: design of a randomized controlled trial. BMC Complement Altern Med. 2017 Mar 13;17(1):153. doi: 10.1186/s12906-017-1672-9.
Laura Porter, PhD
Duke University
65 participants (actual enrollment reported by the registry).
First Submitted
August 16, 2013
First Posted
August 22, 2013
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 20, 2017
Actual (reported)Study Completion
November 20, 2017
Actual (reported)Last Updated
October 9, 2018
Record last verified: 2018-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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