AlopeciaNCT00179348
Yoga-Based Rehabilitation Program in Reducing Physical and Emotional Side Effects in Patients With Cancer
A study testing Quality-of-Life Assessment and Yoga in people with Alopecia and Anxiety, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
This clinical trial studies yoga-based rehabilitation in reducing physical and emotional side effects of living with cancer or its treatment. Yoga-based rehabilitation may reduce side effects and improve the quality of life of patients with breast, lung, or colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia, Anxiety, Breast Carcinoma
- What is being tested?
- Quality-of-Life Assessment and Yoga
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2001to 20 Jul 2016
- 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
- Have been diagnosed with breast, lung or colorectal cancer in the previous 8 weeks
- Are to receive oncologic care at the Albert Einstein Cancer Center (AECC)
- Have a life-expectancy of at least 6 months
- Are either English- or Spanish-speaking
- Do not practice yoga regularly (> 1 month)
- Receive medical clearance by oncologic personnel on the study
Who cannot join
- Eastern Cooperative Oncology Group performance status >= 3
- Existence of any of the following:
- Seizure disorder
- Musculoskeletal conditions
- Heart problems
- Major psychiatric disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: Evaluation of a Yoga-Based Cancer Rehabilitation Program
This clinical trial studies yoga-based rehabilitation in reducing physical and emotional side effects of living with cancer or its treatment. Yoga-based rehabilitation may reduce side effects and improve the quality of life of patients with breast, lung, or colorectal cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the effects of yoga on quality of life (QOL) of breast cancer patients on different treatment regimens.
II. To pilot the effects of a yoga-based rehabilitation program versus standard care on QOL impairment reported by newly diagnosed (a) lung and (b) colorectal patients.
III. To evaluate program compliance and satisfaction among breast, lung and colorectal cancer patients as well as among the various sociocultural subgroups (e.g., ethnicity, language).
OUTLINE: Participants are randomized to 1 of 2 arms.
GROUP I (YOGA-BASED REHABILITATION PROGRAM): Participants undergo a yoga-based rehabilitation program up to 5 days a week for 1.5 hours and practice at home at least once daily for 12 weeks.
GROUP II (STANDARD CARE/CONTROL): After a 3 month wait period, participants undergo yoga-based rehabilitation program as in Group I.
- Conditions
- Alopecia, Anxiety, Breast Carcinoma, Cognitive Side Effects of Cancer Therapy, Colorectal Carcinoma, Depression
- Being tested
- Quality-of-Life Assessment, Yoga
- Medical subject headings
- Alopecia, Anxiety Disorders, Breast Neoplasms, Colorectal Neoplasms, Depression, Fatigue, Lung Neoplasms, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentProcedure or surgery
Also called Quality of Life Assessment
Ancillary studies
YogaProcedure or surgery
Also called Yoga Therapy
Undergo a yoga-based rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| Group I (yoga-based rehabilitation program) | Experimental | Participants undergo a yoga-based rehabilitation program up to 5 days a week for 1.5 hours and practice at home at least once daily for 12 weeks. Receives: Procedure: Quality-of-Life Assessment; Procedure: Yoga |
| Group II (standard care/control) | Active comparator | After a 3 month wait period, participants undergo a yoga-based rehabilitation program as in Group I. Receives: Procedure: Quality-of-Life Assessment; Procedure: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL)
A repeated measures analysis of covariance will be performed for each of the five patient groups. This analysis will examine between and within group differences at T2 and T3 assessment points, after controlling for baseline levels of QOL.
Measured: Baseline to up to 6 months
Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form
Descriptive analyses (percentages) will be conducted to examine levels of compliance (class attendance + home practice) for each patient group, self-identified ethnic group, and language of preference. Logistic regression analyses will be performed to identify patients in the top 25% for compliance based on sociocultural, medical, and lifestyle factors.
Measured: Up to 6 months
Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form
Descriptive analyses (percentages) will be conducted to examine levels of satisfaction (total score on yoga evaluation form) for each patient group, self-identified ethnic group, and language of preference. Logistic regression analyses will be performed to identify patients in the top 25% for satisfaction based on sociocultural, medical, and lifestyle factors.
Measured: Up to 6 months
Secondary outcomes (3)
Pain
Medical chart data will be examined and three separate one-way analysis of variances will be conducted to examine mean differences in adverse medical events, compliance with cancer treatment, and use of pharmacotherapy between intervention and control for each of the five cancer patient groups.
Measured: Baseline to up to 6 months
Mood
Medical chart data will be examined and three separate one-way analysis of variances will be conducted to examine mean differences in adverse medical events, compliance with cancer treatment, and use of pharmacotherapy between intervention and control for each of the five cancer patient groups.
Measured: Baseline to up to 6 months
spiritual well-being
Medical chart data will be examined and three separate one-way analysis of variances will be conducted to examine mean differences in adverse medical events, compliance with cancer treatment, and use of pharmacotherapy between intervention and control for each of the five cancer patient groups.
Measured: Baseline to up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study start8 Feb 2001
- Primary completion20 Jul 2016
- Study completion20 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlopeciaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alyson Moadel, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179348
- Sponsor's protocol ID
- 2000-007
- Other IDs
- NCI-2014-01579, 2000-007, NCI R03 CA88598-01A1, 01-02-038, CCI# 00-7, P30CA013330, R03CA088598
- Status last verified
- May 2023
- First submitted
- 13 Sep 2005
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Moadel AB, Shah C, Wylie-Rosett J, Harris MS, Patel SR, Hall CB, Sparano JA. Randomized controlled trial of yoga among a multiethnic sample of breast cancer patients: effects on quality of life. J Clin Oncol. 2007 Oct 1;25(28):4387-95. doi: 10.1200/JCO.2006.06.6027. Epub 2007 Sep 4.
PubMed 17785709
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Yoga-Based Cancer Rehabilitation Program
- ClinicalTrials.gov ID
- NCT00179348
- Acronym / sponsor ID
- 2000-007
- Conditions
- Alopecia, Anxiety, Breast Carcinoma, Cognitive Side Effects of Cancer Therapy, Colorectal Carcinoma, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Feb 2001 (actual)
- Primary completion
- 20 Jul 2016 (actual)
- Study completion
- 20 Jul 2016 (actual)
- First posted
- 16 Sep 2005 (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 clinical trial studies yoga-based rehabilitation in reducing physical and emotional side effects of living with cancer or its treatment. Yoga-based rehabilitation may reduce side effects and improve the quality of life of patients with breast, lung, or colorectal cancer.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the effects of yoga on quality of life (QOL) of breast cancer patients on different treatment regimens.
II. To pilot the effects of a yoga-based rehabilitation program versus standard care on QOL impairment reported by newly diagnosed (a) lung and (b) colorectal patients.
III. To evaluate program compliance and satisfaction among breast, lung and colorectal cancer patients as well as among the various sociocultural subgroups (e.g., ethnicity, language).
OUTLINE: Participants are randomized to 1 of 2 arms.
GROUP I (YOGA-BASED REHABILITATION PROGRAM): Participants undergo a yoga-based rehabilitation program up to 5 days a week for 1.5 hours and practice at home at least once daily for 12 weeks.
GROUP II (STANDARD CARE/CONTROL): After a 3 month wait period, participants undergo yoga-based rehabilitation program as in Group I.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (yoga-based rehabilitation program) | Experimental | Procedure: Quality-of-Life Assessment, Procedure: YogaParticipants undergo a yoga-based rehabilitation program up to 5 days a week for 1.5 hours and practice at home at least once daily for 12 weeks. |
| Group II (standard care/control) | Active comparator | Procedure: Quality-of-Life Assessment, Procedure: YogaAfter a 3 month wait period, participants undergo a yoga-based rehabilitation program as in Group I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have been diagnosed with breast, lung or colorectal cancer in the previous 8 weeks
- Are to receive oncologic care at the Albert Einstein Cancer Center (AECC)
- Have a life-expectancy of at least 6 months
- Are either English- or Spanish-speaking
- Do not practice yoga regularly (> 1 month)
Key exclusion criteria (6 listed)
- Eastern Cooperative Oncology Group performance status >= 3
- Existence of any of the following:
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 |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Procedure or surgery | Group I (yoga-based rehabilitation program), Group II (standard care/control) |
| YogaAlso: Yoga TherapyUndergo a yoga-based rehabilitation program | Procedure or surgery | Group I (yoga-based rehabilitation program), Group II (standard care/control) |
Primary outcome
Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL)
Time frame: Baseline to up to 6 months
A repeated measures analysis of covariance will be performed for each of the five patient groups. This analysis will examine between and within group differences at T2 and T3 assessment points, after controlling for baseline levels of QOL.
Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form
Time frame: Up to 6 months
Descriptive analyses (percentages) will be conducted to examine levels of compliance (class attendance + home practice) for each patient group, self-identified ethnic group, and language of preference. Logistic regression analyses will be performed to identify patients in the top 25% for compliance based on sociocultural, medical, and lifestyle factors.
Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form
Time frame: Up to 6 months
Descriptive analyses (percentages) will be conducted to examine levels of satisfaction (total score on yoga evaluation form) for each patient group, self-identified ethnic group, and language of preference. Logistic regression analyses will be performed to identify patients in the top 25% for satisfaction based on sociocultural, medical, and lifestyle factors.
3 secondary outcomes
Pain
Time frame: Baseline to up to 6 months
Mood
Time frame: Baseline to up to 6 months
spiritual well-being
Time frame: Baseline to up to 6 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 31 May 2023.
- Derived from this study: PubMed 17785709Moadel AB, Shah C, Wylie-Rosett J, Harris MS, Patel SR, Hall CB, Sparano JA. Randomized controlled trial of yoga among a multiethnic sample of breast cancer patients: effects on quality of life. J Clin Oncol. 2007 Oct 1;25(28):4387-95. doi: 10.1200/JCO.2006.06.6027. Epub 2007 Sep 4.
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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.
Alyson Moadel principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality-of-Life Assessment and Yoga in people with Alopecia and Anxiety, run by Albert Einstein College of Medicine 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 6 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: finished, as of the sponsor's last update on 31 May 2023. 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?
Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL) (time frame: Baseline to up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00179348, which also lists 1 linked publication.
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 31 May 2023; AzTrials last refreshed its copy on 1 Nov 2026.