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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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Study is not feasible
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| yoga therapy | Procedure | Undergo integral yoga intervention with videoconferencing |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Retention rates, calculated as the proportion of enrolled women who complete all study measures at each time point | Up to week 7 | |
| Adherence, measured by the total number of yoga classes attended by each participant | 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. | 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. | Up to week 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in anxiety as measured by HADS |
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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:
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Danhauer | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| internet-based intervention | Other | Undergo integral yoga intervention with videoconferencing |
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| questionnaire administration | Other | Ancillary studies |
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Computed using a mixed model analysis to account for the repeated measures on each subject.
| 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. | 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. | Baseline up to 7 weeks |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D005221 | Fatigue |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
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