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

Primary Purpose

Anxiety Disorder, Depression, Ductal Breast Carcinoma in Situ

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

yoga therapy

internet-based intervention

questionnaire administration

About this trial

This is an interventional supportive care trial for Anxiety Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Comprehensive Cancer Center of Wake Forest University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (internet-based integral yoga intervention)

Arm Description

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.

Outcomes

Primary Outcome Measures

Recruitment rates, calculated as the number of women enrolled divided by the number of women who screened eligible for the study

Retention rates, calculated as the proportion of enrolled women who complete all study measures at each time point

Adherence, measured by the total number of yoga classes attended by each participant

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.

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.

Secondary Outcome Measures

Change in depression as measured by HADS

Computed using a mixed model analysis to account for the repeated measures on each subject.

Change in anxiety as measured by HADS

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

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

Computed using a mixed model analysis to account for the repeated measures on each subject.

Full Information

NCT ID

NCT02023008

First Posted

December 23, 2013

Last Updated

June 29, 2018

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02023008

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Terminated

Why Stopped

Study is not feasible

Study Start Date

May 2014 (Actual)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Supportive care (internet-based integral yoga intervention)

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

yoga therapy

Other Intervention Name(s)

yoga

Intervention Description

Undergo integral yoga intervention with videoconferencing

Intervention Type

Other

Intervention Name(s)

internet-based intervention

Intervention Description

Undergo integral yoga intervention with videoconferencing

Intervention Type

Other

Intervention Name(s)

questionnaire administration

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

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

Title

Retention rates, calculated as the proportion of enrolled women who complete all study measures at each time point

Time Frame

Up to week 7

Title

Adherence, measured by the total number of yoga classes attended by each participant

Time Frame

Up to week 7

Title

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

Description

The proportions and 95% confidence intervals will be calculated. Descriptive statistics will be computed.

Time Frame

Up to week 7

Title

Feedback regarding the participants' experience in the study

Description

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.

Time Frame

Up to week 7

Secondary Outcome Measure Information:

Title

Change in depression as measured by HADS

Description

Computed using a mixed model analysis to account for the repeated measures on each subject.

Time Frame

Baseline up to 7 weeks

Title

Change in anxiety as measured by HADS

Description

Computed using a mixed model analysis to account for the repeated measures on each subject.

Time Frame

Baseline up to 7 weeks

Title

Change in fatigue as measured by visual analogue scale and Functional Assessment of Cancer Therapy-Fatigue

Description

Time Frame

Baseline up to 7 weeks

Title

Change in sleep quality as measured by Pittsburgh Sleep Quality Inventory

Description

Computed using a mixed model analysis to account for the repeated measures on each subject.

Time Frame

Baseline up to 7 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suzanne Danhauer

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Comprehensive Cancer Center of Wake Forest University

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

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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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