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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

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.

Condition or disease Intervention/treatment Phase
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 Procedure: yoga therapy Other: internet-based intervention Other: questionnaire administration Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Convenient and Live Movement (CALM): Feasibility of Interactive Gentle Yoga for Women With Breast Cancer
Actual Study Start Date : May 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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 ]
  2. Retention rates, calculated as the proportion of enrolled women who complete all study measures at each time point [ Time Frame: Up to week 7 ]
  3. Adherence, measured by the total number of yoga classes attended by each participant [ Time Frame: Up to week 7 ]
  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023008


Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Suzanne Danhauer Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02023008     History of Changes
Other Study ID Numbers: 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 )
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Anxiety Disorders
Carcinoma in Situ
Carcinoma, Ductal, Breast
Breast Carcinoma In Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Mental Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary