Interactive Gentle Yoga in Improving Quality of Life in Patients With Stage I-III Breast Cancer Undergoing Radiation Therapy
NCT ID: NCT02023008
Last Updated: 2018-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
6 participants
INTERVENTIONAL
2014-05-31
2015-02-28
Brief Summary
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Detailed Description
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I. To determine the feasibility of implementing a 6-week biweekly yoga intervention delivered by multi-point videoconferencing in breast cancer patients undergoing radiation therapy.
SECONDARY OBJECTIVES:
I. To obtain preliminary data on changes in depression, anxiety, fatigue, sleep quality pre- and post-intervention in women with breast cancer undergoing radiation therapy.
II. To obtain preliminary data on acute effects of the yoga classes on fatigue and distress.
OUTLINE:
Participants undergo 12 sessions of cancer-adapted integral yoga classes using an internet-based videoconferencing platform. Integral yoga includes postures, deep relaxation, breathing practices and meditation to create a profound experience of peace and well-being. Participants take part in study classes from home (or other location that is convenient for the participant and that allows them to access the internet-based classes) with two-way interaction with group instructors and members alike over 75 minutes twice weekly for 6 weeks during radiation therapy. Participants are encouraged to complete additional yoga practice sessions outside of the twice weekly study sessions.
After completion of study, participants are followed up at 1 week.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive care (internet-based integral yoga intervention)
Participants undergo 12 sessions of cancer-adapted integral yoga classes using an internet-based videoconferencing platform. Integral yoga includes postures, deep relaxation, breathing practices and meditation to create a profound experience of peace and well-being. Participants take part in study classes from home (or other location that is convenient for the participant and that allows them to access the internet-based classes) with two-way interaction with group instructors and members alike over 75 minutes twice weekly for 6 weeks during radiation therapy. Participants are encouraged to complete additional yoga practice sessions outside of the twice weekly study sessions.
yoga therapy
Undergo integral yoga intervention with videoconferencing
internet-based intervention
Undergo integral yoga intervention with videoconferencing
questionnaire administration
Ancillary studies
Interventions
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yoga therapy
Undergo integral yoga intervention with videoconferencing
internet-based intervention
Undergo integral yoga intervention with videoconferencing
questionnaire administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have a score \>= 8 on the depression subscale of the Hospital Anxiety and Depression Scale \[HADS\], indicating clinically significant depressive symptoms
* Participants must be:
* \>= 2 weeks post-surgery for women who have had a lumpectomy, a lumpectomy with an axillary node dissection or a mastectomy without reconstruction OR
* \>= 4 weeks post-surgery for women who have had mastectomy with reconstruction
* Participants must be scheduled to begin the standard 6-week course of radiation therapy (RT) within 4 weeks
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* For the duration of RT, participants must have access to an existing broadband internet connection and a computer (laptop or desktop; tablets are not sufficient) with a full-sized computer screen and the following specifications:
* Windows® 8, RT, 7 Vista, XP or 2003 Server or Mac operating system (OS)® X 10.6 (Snow Leopard®) or newer
* Internet Explorer ® 7.0 or newer, Firefox® 4.0 or newer, Safari 3.0 or newer or Chrome or newer (available for free download)
* Participants must be able to understand written/spoken English since the yoga classes will be taught in English
* Ability to understand and the willingness to sign an institutional review board (IRB)-approved written informed consent document
Exclusion Criteria
* Participants who have regularly (defined as 4 or more days per week) engaged in vigorous physical activity (i.e., causes heavy breathing, sweating, rapid fatigue; can be sustained for short periods, like running or swimming strongly) over the past 4 weeks
* Participants who are being treated with a shortened course of radiation therapy (i.e. "Canadian" fractionation less than 5 weeks, partial breast radiation therapy)
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Suzanne Danhauer
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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NCI-2013-02387
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCCWFU 01513
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00026310
Identifier Type: -
Identifier Source: org_study_id
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