Cancer SurvivorsNCT01228955
Yoga Intervention for Cancer Survivors
An observational study of Cancer Survivors and Yoga, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Impaired health related quality of life (HRQOL) including fatigue, problems with sleep and psychosocial well being (physical, emotional, and spiritual) have been noted in adult cancer survivors. Physical domain is one of the most common measured indicators of HRQOL. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer Survivors, Yoga
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Mar 2012
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Survivors of Adult or Pediatric Cancer
Who may be able to join
- Survivor population
- Adults (18 years of age or above)
- Patients treated for any cancers between the ages of 18 and 65 years of age
- Received and concluded cancer treatment anytime from January 1, 2000 up to 1 month before start date of study
- Received cancer treatment and care at either Vanderbilt-Ingram Cancer Center (VICC) or Nashville General Hospital (NGH) or are currently receiving cancer survivorship care at the Vanderbilt REACH for Survivorship Clinic
- Obtain *medical clearance to perform light exercise from primary care physician, oncologist or health care provider at REACH for Survivorship clinic (medical clearance needs to be obtained at least 2 weeks prior to starting yoga class).
Show all 14Show fewer
- Have completed, if ever received, any chemotherapy treatment from January 1, 2000 up to 1 month before start date of study
- Patients with lymphedema due to cancer surgery/treatment are eligible
- Alive without evidence of recurrent disease
- Without evidence of a subsequent malignancy following initial cancer diagnosis
- Provide informed consent
- Should be able to sit on chair/floor and recline without assistance
- Can read and understand English
- Can have past experience with yoga or meditation
Who cannot join
- Enrolled or attending a yoga class at time of recruitment
- Currently receiving active treatment for cancer
- Currently not in remission
- Have any additional health concerns such as brain metastases or ventricular-peritoneal shunts at time of participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Impaired health related quality of life (HRQOL) including fatigue, problems with sleep and psychosocial well being (physical, emotional, and spiritual) have been noted in adult cancer survivors. Physical domain is one of the most common measured indicators of HRQOL. Despite the tremendous implications of having an impaired QOL, few studies have staged interventions aimed at improving HRQOL in a heterogeneous group of cancer survivors. There is little literature examining whether a yoga intervention is feasible in a heterogeneous group of cancer survivors.
The proposed research will utilize Vanderbilt Ingram Cancer Center (VICC), Nashville General Hospital (NGH) and REACH for Survivorship program for a pilot study. The investigators will see if a study using a broad range of diagnoses is feasible for a Yoga Intervention.
Read the detailed description
The Yoga Program
The yoga intervention will be developed by a certified yoga instructor. The yoga instructors teaching the classes will undergo training before teaching classes; all classes will embody the same positions and techniques. Based on Tantric Hatha yoga techniques, the intervention will incorporate physical stretches and poses, breathing exercises and meditation. All exercises will be done in a seated or reclined position. Yoga positions will focus on breathing exercises and basic stretching and will be at the easy or basic level. Yoga positions to be utilized in the intervention are located in the Appendix. Classes will include instruction on practicing the techniques taught in the classes at home.
The yoga instructors utilized in this study are certified in yoga instruction. The classes will be held over a period of 60 minutes in a quiet, dimly lit conference room at Gilda's Club and at Nashville General Hospital. The classes will combine physical postures (asanas), breathing (pranayama) and deep relaxation (savsana). It will be made clear that participants should not practice any pose that causes or exacerbates any discomfort. Yoga poses will be modified based on participants needs. Individual poses will be held from 20 seconds to 5 minutes depending on the poses. Classes will begin slowly and progress; adding poses to the same sequence, breath techniques and restorative poses for each class over the 10 weeks. Modifications and pose variations will be used to make the class appropriate for each individual. Chairs, yoga props, and a wall will be used to assist in poses. The class will consist of the following outline:
5 Minutes: Centering, Relaxation, Body Scan
- Seated (Sukasana, Simple Cross Legged Pose)
- Reclined (Savasana, Relaxation Pose) 10 minutes: Breathing techniques
- Diaphramic breathing (belly breath)
- Ujjayi breathing (builds heat and is an audible breath)
- Kapalabhati breathing (pumping breath)
- Nadi Sodhana breathing (alternate nostril breath) 10 minutes: Warming spine and body
- Cat/Cow
- Twists
- 1/2 Sun Salutations and variations 15 minutes: Strength building and stretching poses
- Hamstring Opener (reclined)
- Downward Dog (at wall or on floor)
- Lunges (at wall, with chair or with no props)
- Bridge Pose
- Locust Pose (with variations) 5 minutes: Restorative Poses
- Supported Bridge Pose
- Supported Child's Pose
- Supported Forward Twist
- Legs up Wall
- (rotate restorative poses throughout 10 weeks) 5 minutes:
- Savasana (final relaxation) 5 minutes:
- Mindfulness Meditation
More details about the positions are located in the Appendix.
Study Instruments
Short Form 36 (MOS SF-36): The MOS SF-36 contains eight individual scales from which we will generate the Physical Component (PCS) and the Mental Component Summary (MCS) scores. The eight scales include physical functioning, role function-physical, bodily pain, social functioning, mental health, role function-emotional, vitality and general health perceptions [33]. The MOS SF 36 has been validated in the general population and population norms have been established for comparison between specific groups. Each scale is scored from 0-100, with 100 being the most favorable score. The SF-36 has been validated in the general population and population norms have been established for comparison between specific groups. The summary scales have been standardized to a reference normal healthy population, with a mean score of 50 and deviation of 10 points. Within the SF-36 is a 4 item Vitality scale which can be used to determine the presence or absence of fatigue.
Brief Symptom Inventory-The BSI is a short 53 item instrument designed to measure three dimensions of psychological distress - somatization, depression and anxiety. Raw scores are converted to T scores on the basis of normative data. The T scores are then dichotomized, in which a T score 63 classified a respondent as having psychological distress.
Survivor Questionnaire: A self-report questionnaire will be used to ascertain all demographic and historical information on race, age, income, education, current and past employment status, and current and past marital status. Current medical conditions will be selected by the participant from checklist including major medical conditions including secondary malignancy, cardiac, pulmonary and thyroid dysfunction. In addition, participants will be asked to list their current medications such as thyroid replacement, immunosuppressants, and anti-depressants. Lifetime smoking and alcohol habits will also be quantified, as well as reproductive history.
- Conditions
- Cancer Survivors, Yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Group | Group will enter a 10 week yoga class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cancer Survivors interested and willing to participate in a 10 week yoga class at Vanderbilt Ingram Cancer Center (VICC) and at Nashville General Hospital
The investigators will be opening up an hourly yoga class for 10 weeks to all cancer survivors at VICC and at Nashville General Hospital
Measured: 12 months
Secondary outcomes (1)
Levels of Fatigue using the SF-36 and Psychological Distress using BSI-18
Participants in the Yoga Study will be asked to complete the SF-36 and BSI-18 at three different time points in the study. Prior to start of a yoga class, at the end of the 10 week yoga class and 3 months after the completion of the yoga class.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Debra Friedman, Vanderbilt University Medical Center
- Investigators
- Debra L Friedman, MD, MS, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228955
- Sponsor's protocol ID
- 091309
- Status last verified
- Apr 2017
- First submitted
- 15 Oct 2010
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga Intervention for Cancer Survivors
- ClinicalTrials.gov ID
- NCT01228955
- Acronym / sponsor ID
- 091309
- Conditions
- Cancer Survivors, Yoga
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 27 Oct 2010 (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.
Impaired health related quality of life (HRQOL) including fatigue, problems with sleep and psychosocial well being (physical, emotional, and spiritual) have been noted in adult cancer survivors. Physical domain is one of the most common measured indicators of HRQOL. Despite the tremendous implications of having an impaired QOL, few studies have staged interventions aimed at improving HRQOL in a heterogeneous group of cancer survivors. There is little literature examining whether a yoga intervention is feasible in a heterogeneous group of cancer survivors.
The proposed research will utilize Vanderbilt Ingram Cancer Center (VICC), Nashville General Hospital (NGH) and REACH for Survivorship program for a pilot study. The investigators will see if a study using a broad range of diagnoses is feasible for a Yoga Intervention.
Detailed description
The Yoga Program
The yoga intervention will be developed by a certified yoga instructor. The yoga instructors teaching the classes will undergo training before teaching classes; all classes will embody the same positions and techniques. Based on Tantric Hatha yoga techniques, the intervention will incorporate physical stretches and poses, breathing exercises and meditation. All exercises will be done in a seated or reclined position. Yoga positions will focus on breathing exercises and basic stretching and will be at the easy or basic level. Yoga positions to be utilized in the intervention are located in the Appendix. Classes will include instruction on practicing the techniques taught in the classes at home.
The yoga instructors utilized in this study are certified in yoga instruction. The classes will be held over a period of 60 minutes in a quiet, dimly lit conference room at Gilda's Club and at Nashville General Hospital. The classes will combine physical postures (asanas), breathing (pranayama) and deep relaxation (savsana). It will be made clear that participants should not practice any pose that causes or exacerbates any discomfort. Yoga poses will be modified based on participants needs. Individual poses will be held from 20 seconds to 5 minutes depending on the poses. Classes will begin slowly and progress; adding poses to the same sequence, breath techniques and restorative poses for each class over the 10 weeks. Modifications and pose variations will be used to make the class appropriate for each individual. Chairs, yoga props, and a wall will be used to assist in poses. The class will consist of the following outline:
5 Minutes: Centering, Relaxation, Body Scan
- Seated (Sukasana, Simple Cross Legged Pose)
- Reclined (Savasana, Relaxation Pose) 10 minutes: Breathing techniques
- Diaphramic breathing (belly breath)
- Ujjayi breathing (builds heat and is an audible breath)
- Kapalabhati breathing (pumping breath)
- Nadi Sodhana breathing (alternate nostril breath) 10 minutes: Warming spine and body
- Cat/Cow
- Twists
- 1/2 Sun Salutations and variations 15 minutes: Strength building and stretching poses
- Hamstring Opener (reclined)
- Downward Dog (at wall or on floor)
- Lunges (at wall, with chair or with no props)
- Bridge Pose
- Locust Pose (with variations) 5 minutes: Restorative Poses
- Supported Bridge Pose
- Supported Child's Pose
- Supported Forward Twist
- Legs up Wall
- (rotate restorative poses throughout 10 weeks) 5 minutes:
- Savasana (final relaxation) 5 minutes:
- Mindfulness Meditation
More details about the positions are located in the Appendix.
Study Instruments
Short Form 36 (MOS SF-36): The MOS SF-36 contains eight individual scales from which we will generate the Physical Component (PCS) and the Mental Component Summary (MCS) scores. The eight scales include physical functioning, role function-physical, bodily pain, social functioning, mental health, role function-emotional, vitality and general health perceptions [33]. The MOS SF 36 has been validated in the general population and population norms have been established for comparison between specific groups. Each scale is scored from 0-100, with 100 being the most favorable score. The SF-36 has been validated in the general population and population norms have been established for comparison between specific groups. The summary scales have been standardized to a reference normal healthy population, with a mean score of 50 and deviation of 10 points. Within the SF-36 is a 4 item Vitality scale which can be used to determine the presence or absence of fatigue.
Brief Symptom Inventory-The BSI is a short 53 item instrument designed to measure three dimensions of psychological distress - somatization, depression and anxiety. Raw scores are converted to T scores on the basis of normative data. The T scores are then dichotomized, in which a T score 63 classified a respondent as having psychological distress.
Survivor Questionnaire: A self-report questionnaire will be used to ascertain all demographic and historical information on race, age, income, education, current and past employment status, and current and past marital status. Current medical conditions will be selected by the participant from checklist including major medical conditions including secondary malignancy, cardiac, pulmonary and thyroid dysfunction. In addition, participants will be asked to list their current medications such as thyroid replacement, immunosuppressants, and anti-depressants. Lifetime smoking and alcohol habits will also be quantified, as well as reproductive history.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga Group | – | –Group will enter a 10 week yoga class |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Survivors of Adult or Pediatric Cancer
Key inclusion criteria (14 listed)
- Survivor population
- Adults (18 years of age or above)
- Patients treated for any cancers between the ages of 18 and 65 years of age
- Received and concluded cancer treatment anytime from January 1, 2000 up to 1 month before start date of study
- Received cancer treatment and care at either Vanderbilt-Ingram Cancer Center (VICC) or Nashville General Hospital (NGH) or are currently receiving cancer survivorship care at the Vanderbilt REACH for Survivorship Clinic
Key exclusion criteria (4 listed)
- Enrolled or attending a yoga class at time of recruitment
- Currently receiving active treatment for cancer
- Currently not in remission
- Have any additional health concerns such as brain metastases or ventricular-peritoneal shunts at time of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Cancer Survivors interested and willing to participate in a 10 week yoga class at Vanderbilt Ingram Cancer Center (VICC) and at Nashville General Hospital
Time frame: 12 months
The investigators will be opening up an hourly yoga class for 10 weeks to all cancer survivors at VICC and at Nashville General Hospital
1 secondary outcome
Levels of Fatigue using the SF-36 and Psychological Distress using BSI-18
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Debra L Friedman, MD, MS principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Survivors and Yoga, run by Vanderbilt University Medical 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 14 inclusion and 4 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: finished, as of the sponsor's last update on 6 Apr 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Cancer Survivors interested and willing to participate in a 10 week yoga class at Vanderbilt Ingram Cancer Center (VICC) and at Nashville General Hospital (time frame: 12 months). 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 6 Apr 2017.