Interactive Gentle Yoga in Improving Quality of Life in Patients With Stage I-III Breast Cancer Undergoing Radiation Therapy



Status:Terminated
Conditions:Anxiety, Breast Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Depression, Depression, Other Indications
Therapuetic Areas:Oncology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - Any
Updated:7/4/2018
Start Date:May 2014
End Date:February 2015

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Convenient and Live Movement (CALM): Feasibility of Interactive Gentle Yoga for Women With Breast Cancer

This pilot clinical trial studies interactive gentle yoga in improving quality of life in
patients with stage I-III breast cancer undergoing radiation therapy. Interactive gentle yoga
may improve the quality of life in patients with breast cancer undergoing radiation therapy.

PRIMARY OBJECTIVES:

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.

Inclusion Criteria:

- Participants must be newly diagnosed with a histologically or cytologically confirmed
breast cancer stage I-III (ductal carcinoma in situ [DCIS] is allowed)

- 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 practiced yoga regularly (defined as at least once per week on
average) in the past 3 months

- 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)
We found this trial at
1
site
Medical Center Boulevard
Winston-Salem, North Carolina 27157
336-716-2255
Comprehensive Cancer Center of Wake Forest University Our newly expanded Comprehensive Cancer Center is the...
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mi
from
Winston-Salem, NC
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