Breast CarcinomaNCT02923037
Hatha Yoga in Breast Cancer Survivors
A study testing Yoga, tape measurement of arm and Quality-of-Life Assessment in people with Breast Carcinoma and Lymphedema, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies Hatha yoga in reducing physical and emotional problems in breast cancer survivors with stage II-III lymphedema. Yoga practices may benefit breast cancer survivors with lymphedema as they directly support lymph transport (postures, breathing, relaxation) and emotional well-being… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Lymphedema
- What is being tested?
- Yoga, tape measurement of arm and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lymphedema Group:
- Lymphedema, symptomatic of stage II or III based upon screening responses; or L-Dex reading of ≥ 7 at initial visit,
- > 3 months (mths) post-breast cancer treatment
- No active cancer
- Has compression sleeve
- Ability to understand English in order to complete questionnaires
Show all 19Show fewer
- Willing to do guided and home yoga practice
- Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire
- Medical clearance
- Reliable transportation to the study site
- No Lymphedema Group:
- No known lymphedema or intermittent swelling, not symptomatic of Stage II or III lymphedema (L-Dex ≥ 7)
- >3 months post- breast cancer treatment
- No active cancer
- Ability to understand English in order to complete questionnaires
- Willing to do guided and home Yoga practice
- Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire
- Medical clearance
- Reliable transportation to the study site.
Who cannot join
- Active cancer
- Undergoing radiation therapy or chemotherapy
- Medical conditions that would prohibit the safe implementation of a yoga practice (e.g., vertigo, compromised mental status)
- Active yoga practice < 3 months
- Currently undergoing phase I complete decongestive therapy (CDT)
- Inability to complete study forms
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University School of Nursing
Nashville, Tennessee, 37232
About this study
Official title: Feasibility and Preliminary Efficacy of Hatha Yoga in Breast Cancer Survivors: Pilot Study
This pilot clinical trial studies Hatha yoga in reducing physical and emotional problems in breast cancer survivors with stage II-III lymphedema. Yoga practices may benefit breast cancer survivors with lymphedema as they directly support lymph transport (postures, breathing, relaxation) and emotional well-being (relaxation, meditation).
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of a modified yoga program for breast cancer survivors (BCS) with lymphedema.
II. To identify and document required modifications for a safe and feasible practice.
III. To obtain recruitment estimates and determine barriers to recruitment (acceptability).
IV. To evaluate implementation fidelity (adherence and competence) and barriers to implementation fidelity.
- To establish safety. VI. To assess satisfaction. VII. To determine the preliminary efficacy of a modified yoga program for lymphedema in BCS, and associated physical and psychological symptoms/symptom burden, and overall health status.
OUTLINE:
Patients undergo an initial yoga evaluation for 60 minutes. Patients then undergo their first guided yoga practice session for 30-60 minutes and subsequent guided yoga sessions for 30-90 minutes.
3 times a week for 4 weeks, and twice a week for an additional 4 weeks. Patients are also encouraged to complete home yoga practice for 30 to 90 minutes every day for 8 weeks.
- Conditions
- Breast Carcinoma, Lymphedema
- Being tested
- Yoga, tape measurement of arm, Quality-of-Life Assessment, ldex measurement of arms
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaProcedure or surgery
Complete guided and home yoga sessions
tape measurement of armOther
Ancillary studies
Quality-of-Life AssessmentOther
Ancillary studies
ldex measurement of armsOther
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (Yoga) | Experimental | Patients undergo an initial yoga evaluation for 60 minutes. Patients then undergo their first guided yoga practice session for 30-60 minutes and subsequent guided yoga sessions for 30-90 minutes 3 times a week for 4 weeks, and twice a week for an additional 4 weeks. Patients are also encouraged to complete home yoga practice for 30 to 90 minutes every day for 8 weeks. They will have tape measurement of arms and ldex measurement of arms. Quality-of-Life Assessment will also be made. Receives: Procedure: Yoga; Other: tape measurement of arm; Other: Quality-of-Life Assessment; Other: ldex measurement of arms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pose Modifications
number of poses requiring modifications as indicated in the modification form
Measured: Up to 8 weeks
Assess safety
Number of participants with treatment-related adverse events as assessed by the CTCAE v4.0
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start1 Sep 2016
- Primary completionNov 2018
- Study completionMar 2019
Why it stopped: Insufficient staff and funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sheila Ridner, Vanderbilt-Ingram Cancer Center
- Investigators
- Sheila Ridner, PhD, RN, Principal investigator, Vanderbilt University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923037
- Sponsor's protocol ID
- VICC BRE 16104
- Other IDs
- NCI-2016-01402
- Status last verified
- Mar 2019
- First submitted
- 29 Sep 2016
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of Hatha Yoga in Breast Cancer Survivors: Pilot Study
- ClinicalTrials.gov ID
- NCT02923037
- Acronym / sponsor ID
- VICC BRE 16104
- Conditions
- Breast Carcinoma, Lymphedema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient staff and funding
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies Hatha yoga in reducing physical and emotional problems in breast cancer survivors with stage II-III lymphedema. Yoga practices may benefit breast cancer survivors with lymphedema as they directly support lymph transport (postures, breathing, relaxation) and emotional well-being (relaxation, meditation).
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of a modified yoga program for breast cancer survivors (BCS) with lymphedema.
II. To identify and document required modifications for a safe and feasible practice.
III. To obtain recruitment estimates and determine barriers to recruitment (acceptability).
IV. To evaluate implementation fidelity (adherence and competence) and barriers to implementation fidelity.
- To establish safety. VI. To assess satisfaction. VII. To determine the preliminary efficacy of a modified yoga program for lymphedema in BCS, and associated physical and psychological symptoms/symptom burden, and overall health status.
OUTLINE:
Patients undergo an initial yoga evaluation for 60 minutes. Patients then undergo their first guided yoga practice session for 30-60 minutes and subsequent guided yoga sessions for 30-90 minutes.
3 times a week for 4 weeks, and twice a week for an additional 4 weeks. Patients are also encouraged to complete home yoga practice for 30 to 90 minutes every day for 8 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (Yoga) | Experimental | Procedure: Yoga, Other: tape measurement of arm, Other: Quality-of-Life Assessment, Other: ldex measurement of armsPatients undergo an initial yoga evaluation for 60 minutes. Patients then undergo their first guided yoga practice session for 30-60 minutes and subsequent guided yoga sessions for 30-90 minutes 3 times a week for 4 weeks, and twice a week for an additional 4 weeks. Patients are also encouraged to complete home yoga practice for 30 to 90 minutes every day for 8 weeks. They will have tape measurement of arms and ldex measurement of arms. Quality-of-Life Assessment will also be made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Lymphedema, symptomatic of stage II or III based upon screening responses; or L-Dex reading of ≥ 7 at initial visit,
- > 3 months (mths) post-breast cancer treatment
- No active cancer
- Has compression sleeve
- Ability to understand English in order to complete questionnaires
Key exclusion criteria (6 listed)
- Active cancer
- Undergoing radiation therapy or chemotherapy
- Medical conditions that would prohibit the safe implementation of a yoga practice (e.g., vertigo, compromised mental status)
- Active yoga practice < 3 months
- Currently undergoing phase I complete decongestive therapy (CDT)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaComplete guided and home yoga sessions | Procedure or surgery | Supportive Care (Yoga) |
| tape measurement of armAncillary studies | Other | Supportive Care (Yoga) |
| Quality-of-Life AssessmentAncillary studies | Other | Supportive Care (Yoga) |
| ldex measurement of arms | Other | Supportive Care (Yoga) |
Primary outcome
Pose Modifications
Time frame: Up to 8 weeks
number of poses requiring modifications as indicated in the modification form
Assess safety
Time frame: Up to 8 weeks
Number of participants with treatment-related adverse events as assessed by the CTCAE v4.0
Results and safety
The study was stopped early (reason given: Insufficient staff and funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila Ridner, PhD, RN principal investigator
Vanderbilt University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga, tape measurement of arm and Quality-of-Life Assessment in people with Breast Carcinoma and Lymphedema, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient staff and funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pose Modifications (time frame: Up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.