Clinical trial · Interventional
Interactive Gentle Yoga in Improving Quality of Life in Patients With Stage I-III Breast Cancer Undergoing Radiation Therapy
Convenient and Live Movement (CALM): Feasibility of Interactive Gentle Yoga for Women With Breast Cancer
NCT02023008CI-TRIAL-00033559terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study is not feasible
Summary
Brief summary (as posted)
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
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety Disorder | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Ductal Breast Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Fatigue | — | UNRESOLVED | — |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| internet-based intervention | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| yoga therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (internet-based integral yoga intervention)
- 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.
- interventionNames
- Procedure: yoga therapy
- Other: internet-based intervention
- Other: questionnaire administration
Primary outcomes (5)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.