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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02023008
• Other study ID #: IRB00026310
• Secondary ID: NCI-2013-02387CC
• Status: Terminated
• Phase: N/A
• Start date: May 2014
• Est. completion date: February 2015

Study information

• Verified date: June 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma in Situ
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• Depression
• Ductal Breast Carcinoma in Situ
• Fatigue
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer

Intervention

Procedure:
• yoga therapy
Undergo integral yoga intervention with videoconferencing

Other:
• internet-based intervention
Undergo integral yoga intervention with videoconferencing
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Retention rates, calculated as the proportion of enrolled women who complete all study measures at each time point		Up to week 7
Primary	Adherence, measured by the total number of yoga classes attended by each participant		Up to week 7
Primary	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	The proportions and 95% confidence intervals will be calculated. Descriptive statistics will be computed.	Up to week 7
Primary	Feedback regarding the participants' experience in the study	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.	Up to week 7
Secondary	Change in depression as measured by HADS	Computed using a mixed model analysis to account for the repeated measures on each subject.	Baseline up to 7 weeks
Secondary	Change in anxiety as measured by HADS	Computed using a mixed model analysis to account for the repeated measures on each subject.	Baseline up to 7 weeks
Secondary	Change in fatigue as measured by visual analogue scale and Functional Assessment of Cancer Therapy-Fatigue	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.	Baseline up to 7 weeks
Secondary	Change in sleep quality as measured by Pittsburgh Sleep Quality Inventory	Computed using a mixed model analysis to account for the repeated measures on each subject.	Baseline up to 7 weeks