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

Not Applicable

Terminated

• Conditions: Anxiety Disorder; Stage IIIA Breast Cancer; Ductal Breast Carcinoma in Situ; Fatigue; Stage IIIB Breast Cancer; Stage II Breast Cancer; Depression; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIIC Breast Cancer
• Interventions: Procedure: yoga therapy; Other: internet-based intervention; Other: questionnaire administration

• Registration Number: NCT02023008
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-12-23
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-30
• Study Start: 2014-05
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 6

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (internet-based integral yoga intervention)	internet-based 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.
Supportive care (internet-based integral yoga intervention)	questionnaire administration	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.
Supportive care (internet-based integral yoga intervention)	yoga therapy	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.

Primary Outcome Measures

Name	Time	Method
Recruitment rates, calculated as the number of women enrolled divided by the number of women who screened eligible for the study	Up to week 7
Feedback regarding the participants' experience in the study	Up to week 7	Qualitative analysis of open-ended feedback on strengths and weaknesses of the yoga intervention and teacher, use of the multi-point videoconferencing device will be performed.
Retention rates, calculated as the proportion of enrolled women who complete all study measures at each time point	Up to week 7
Participants' acceptability of the intervention, including ratings of ease/difficulty of use of the videoconferencing and participating in group classes from home using the device	Up to week 7	The proportions and 95% confidence intervals will be calculated. Descriptive statistics will be computed.
Adherence, measured by the total number of yoga classes attended by each participant	Up to week 7

Secondary Outcome Measures

Name	Time	Method
Change in depression as measured by HADS	Baseline up to 7 weeks	Computed using a mixed model analysis to account for the repeated measures on each subject.
Change in anxiety as measured by HADS	Baseline up to 7 weeks	Computed using a mixed model analysis to account for the repeated measures on each subject.
Change in sleep quality as measured by Pittsburgh Sleep Quality Inventory	Baseline up to 7 weeks	Computed using a mixed model analysis to account for the repeated measures on each subject.
Change in fatigue as measured by visual analogue scale and Functional Assessment of Cancer Therapy-Fatigue	Baseline up to 7 weeks	Computed using a mixed model analysis to account for the repeated measures on each subject. Assessed by calculating the difference in the post and pre scores for each session, and then examining whether there is a time effect using a mixed model.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States