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

Wake Forest University (WFU)

Status: Terminated

Conditions: Stage IIIA Breast Cancer; Stage IB Breast Cancer; Stage IIIB Breast Cancer; Anxiety Disorder; Stage IIIC Breast Cancer; Stage II Breast Cancer; Stage IA Breast Cancer; Ductal Breast Carcinoma in Situ; Depression; Fatigue

Treatments: Other: questionnaire administration; Procedure: yoga therapy; Other: internet-based intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02023008

P30CA012197 (U.S. NIH Grant/Contract)

NCI-2013-02387 (Registry Identifier)

IRB00026310

CCCWFU 01513 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Supportive care (internet-based integral yoga intervention)

Experimental group

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.

Treatment:

Other: internet-based intervention

Procedure: yoga therapy

Other: questionnaire administration