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

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ClinicalTrials.gov Identifier: NCT02023008
Recruitment Status : Terminated (Study is not feasible)
First Posted : December 30, 2013
Last Update Posted : July 2, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE December 23, 2013
First Posted Date  ICMJE December 30, 2013
Last Update Posted Date July 2, 2018
Actual Study Start Date  ICMJE May 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
  • Recruitment rates, calculated as the number of women enrolled divided by the number of women who screened eligible for the study [ Time Frame: Up to week 7 ]
  • Retention rates, calculated as the proportion of enrolled women who complete all study measures at each time point [ Time Frame: Up to week 7 ]
  • Adherence, measured by the total number of yoga classes attended by each participant [ Time Frame: 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 [ Time Frame: Up to week 7 ]
    The proportions and 95% confidence intervals will be calculated. Descriptive statistics will be computed.
  • Feedback regarding the participants' experience in the study [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
  • Change in depression as measured by HADS [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
  • Change in sleep quality as measured by Pittsburgh Sleep Quality Inventory [ Time Frame: Baseline up to 7 weeks ]
    Computed using a mixed model analysis to account for the repeated measures on each subject.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interactive Gentle Yoga in Improving Quality of Life in Patients With Stage I-III Breast Cancer Undergoing Radiation Therapy
Official Title  ICMJE Convenient and Live Movement (CALM): Feasibility of Interactive Gentle Yoga for Women With Breast Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Anxiety Disorder
  • 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  ICMJE
  • Procedure: yoga therapy
    Undergo integral yoga intervention with videoconferencing
    Other Name: yoga
  • Other: internet-based intervention
    Undergo integral yoga intervention with videoconferencing
  • Other: questionnaire administration
    Ancillary studies
Study Arms  ICMJE Experimental: 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.
Interventions:
  • Procedure: yoga therapy
  • Other: internet-based intervention
  • Other: questionnaire administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 3, 2015)
6
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2013)
10
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02023008
Other Study ID Numbers  ICMJE IRB00026310
NCI-2013-02387 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 01513 ( Other Identifier: Comprehensive Cancer Center of Wake Forest University )
P30CA012197 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Suzanne Danhauer Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP