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

NCT02023008 | Terminated

• 4 other identifiers: IRB00026310NCI-2013-02387CCCWFU 01513P30CA012197
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (4)

• Change in depression as measured by HADS

  Baseline up to 7 weeks

• Change in anxiety as measured by HADS

  Baseline up to 7 weeks

• Change in fatigue as measured by visual analogue scale and Functional Assessment of Cancer Therapy-Fatigue

  Baseline up to 7 weeks

• Change in sleep quality as measured by Pittsburgh Sleep Quality Inventory

  Baseline up to 7 weeks

Study Arms (1)

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.

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

Interventions

yoga therapy PROCEDURE

Undergo integral yoga intervention with videoconferencing

Also known as: yoga

Supportive care (internet-based integral yoga intervention)

internet-based intervention OTHER

Undergo integral yoga intervention with videoconferencing

Supportive care (internet-based integral yoga intervention)

questionnaire administration OTHER

Ancillary studies

Supportive care (internet-based integral yoga intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Carcinoma, Intraductal, Noninfiltrating; Fatigue; Breast Neoplasms

Interventions

Yoga

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Suzanne Danhauer

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: December 30, 2013
• Study Start: May 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 2, 2018

Record last verified: 2018-06

Locations

US (1)