Depression Clinical Trial
Official title:
Convenient and Live Movement (CALM): Feasibility of Interactive Gentle Yoga for Women With Breast Cancer
Verified date | June 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Primary | Retention rates, calculated as the proportion of enrolled women who complete all study measures at each time point | Up to week 7 | ||
Primary | Adherence, measured by the total number of yoga classes attended by each participant | Up to week 7 | ||
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Change in anxiety as measured by HADS | Computed using a mixed model analysis to account for the repeated measures on each subject. | Baseline up to 7 weeks | |
Secondary | 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 | |
Secondary | 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 |
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