Clinical trial NCT02023008: 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
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-12-30
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Recruitment rates, calculated as the number of women enrolled divided by the number of women who screened eligible for the study
timeFrame: Up to week 7
measure: Retention rates, calculated as the proportion of enrolled women who complete all study measures at each time point
timeFrame: Up to week 7
measure: Adherence, measured by the total number of yoga classes attended by each participant
timeFrame: Up to week 7
measure: 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
timeFrame: Up to week 7
measure: Feedback regarding the participants' experience in the study
timeFrame: Up to week 7
Secondary outcomes:
measure: Change in depression as measured by HADS
timeFrame: Baseline up to 7 weeks
measure: Change in anxiety as measured by HADS
timeFrame: Baseline up to 7 weeks
measure: Change in fatigue as measured by visual analogue scale and Functional Assessment of Cancer Therapy-Fatigue
timeFrame: Baseline up to 7 weeks
measure: Change in sleep quality as measured by Pittsburgh Sleep Quality Inventory
timeFrame: Baseline up to 7 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Suzanne Danhauer
role: PRINCIPAL_INVESTIGATOR
References: