Anxiety DisorderNCT02023008
Interactive Gentle Yoga in Improving Quality of Life in Patients With Stage I-III Breast Cancer Undergoing Radiation Therapy
A study testing yoga therapy, internet-based intervention and questionnaire administration in people with Anxiety Disorder and Depression, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety Disorder, Depression, Ductal Breast Carcinoma in Situ
- What is being tested?
- yoga therapy, internet-based intervention and questionnaire administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Convenient and Live Movement (CALM): Feasibility of Interactive Gentle Yoga for Women With Breast Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Anxiety Disorder, Depression, Ductal Breast Carcinoma in Situ, Fatigue, Stage IA Breast Cancer, Stage IB Breast Cancer
- Being tested
- yoga therapy, internet-based intervention, questionnaire administration
- Medical subject headings
- Anxiety Disorders, Depression, Carcinoma, Intraductal, Noninfiltrating, Fatigue, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yoga therapyProcedure or surgery
Also called yoga
Undergo integral yoga intervention with videoconferencing
internet-based interventionOther
Undergo integral yoga intervention with videoconferencing
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (internet-based integral yoga intervention) | Experimental | 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. Receives: Procedure: yoga therapy; Other: internet-based intervention; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates, calculated as the number of women enrolled divided by the number of women who screened eligible for the study
Measured: Up to week 7
Retention rates, calculated as the proportion of enrolled women who complete all study measures at each time point
Measured: Up to week 7
Adherence, measured by the total number of yoga classes attended by each participant
Measured: 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
The proportions and 95% confidence intervals will be calculated. Descriptive statistics will be computed.
Measured: Up to week 7
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.
Measured: Up to week 7
Secondary outcomes (4)
Change in depression as measured by HADS
Computed using a mixed model analysis to account for the repeated measures on each subject.
Measured: Baseline up to 7 weeks
Change in anxiety as measured by HADS
Computed using a mixed model analysis to account for the repeated measures on each subject.
Measured: Baseline up to 7 weeks
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.
Measured: Baseline up to 7 weeks
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.
Measured: Baseline up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startMay 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Study is not feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Suzanne Danhauer, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023008
- Sponsor's protocol ID
- IRB00026310
- Other IDs
- NCI-2013-02387, CCCWFU 01513, P30CA012197
- Status last verified
- Jun 2018
- First submitted
- 23 Dec 2013
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convenient and Live Movement (CALM): Feasibility of Interactive Gentle Yoga for Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT02023008
- Acronym / sponsor ID
- IRB00026310
- Conditions
- Anxiety Disorder, Depression, Ductal Breast Carcinoma in Situ, Fatigue, Stage IA Breast Cancer, Stage IB Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study is not feasible
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2014 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (internet-based integral yoga intervention) | Experimental | Procedure: yoga therapy, Other: internet-based intervention, Other: questionnaire administrationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| yoga therapyAlso: yogaUndergo integral yoga intervention with videoconferencing | Procedure or surgery | Supportive care (internet-based integral yoga intervention) |
| internet-based interventionUndergo integral yoga intervention with videoconferencing | Other | Supportive care (internet-based integral yoga intervention) |
| questionnaire administrationAncillary studies | Other | Supportive care (internet-based integral yoga intervention) |
Primary outcome
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.
4 secondary outcomes
Change in depression as measured by HADS
Time frame: Baseline up to 7 weeks
Change in anxiety as measured by HADS
Time frame: Baseline up to 7 weeks
Change in fatigue as measured by visual analogue scale and Functional Assessment of Cancer Therapy-Fatigue
Time frame: Baseline up to 7 weeks
Change in sleep quality as measured by Pittsburgh Sleep Quality Inventory
Time frame: Baseline up to 7 weeks
Results and safety
The study was stopped early (reason given: Study is not feasible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Danhauer principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yoga therapy, internet-based intervention and questionnaire administration in people with Anxiety Disorder and Depression, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study is not feasible). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.