Breast CancerNCT00006346
Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer
A study testing psychosocial assessment and care and quality-of-life assessment in people with Breast Cancer and Psychosocial Effects of Cancer and Its Treatment, run by Unity Health Toronto at 3 sites in United States.
Trial summary
RATIONALE: Transcendental meditation may be an effective way to decrease the amount of stress in older women with breast cancer. It is not yet known if transcendental meditation is more effective than basic breast cancer education in improving quality of life. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Breast Cancer, Psychosocial Effects of Cancer and Its Treatment
- What is being tested?
- psychosocial assessment and care and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Aug 2000to Sep 2003
- 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 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of stage II, III, or IV breast cancer
- No brain or CNS metastases
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 55 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No non-cancer life-threatening illness
- No history of major psychiatric disorders
- No drug abuse dependency disorder
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Trial locations and contacts
3 sites in 1 country.
United States3 sites
St. Joseph Hospital
Chicago, Illinois, 60657
Maharishi International University
Fairfield, Iowa, 52557
Hope Center
Terre Haute, Indiana, 47809
About this study
Official title: Stress Reduction For Breast Cancer in Women 55 Years of Age or Older: Enhancing Quality of Life and Survival
RATIONALE: Transcendental meditation may be an effective way to decrease the amount of stress in older women with breast cancer. It is not yet known if transcendental meditation is more effective than basic breast cancer education in improving quality of life.
PURPOSE: This randomized clinical trialstudies stress reduction in improvingquality of life in older women with stage II, stage III, or stage IV breast cancer.
Read the detailed description
OBJECTIVES:
- Compare the effects of active stress reduction with transcendental meditation vs basic breast cancer education on quality of life and survival time in older women with stage II, III, or IV breast cancer.
- Determine behavioral mechanisms that may mediate the effects of stress reduction on survival in these patients.
- Determine baseline variables that contribute to predicting survival time in these patients.
OUTLINE: This is a randomized, single blind (to medical staff), multicenter study. Patients are stratified according to age and participation in support groups. Patients with stage IV disease are also stratified according to type of metastases (visceral vs non-visceral) and timing of metastases (first diagnosis vs recurrence). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive usual medical care and instruction on stress reduction using transcendental meditation (TM), which involves a standard 7-step course. Patients attend training for approximately 1-1.5 hours per session for a total of 6 sessions over 1 week, while receiving usual medical care. Patients then practice TM twice a day for 20 minutes. Patients attend group meetings for approximately 90 minutes once or twice monthly for 6 months to ensure proper technique and understanding.
- Arm II: Patients receive usual medical care and basic literature on breast cancer.
Quality of life is assessed at baseline and then every 6 months for up to 3 years.
Patients are followed monthly for up to 2.5 years.
PROJECTED ACCRUAL: Approximately 166 patients (83 per treatment arm) will be accrued for this study within 6 months.
- Being tested
- psychosocial assessment and care, quality-of-life assessment
- Keywords
- stage II breast cancer, stage IV breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, psychosocial effects of cancer and its treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2003 (estimated)
- Study startAug 2000
- Study completionSep 2003
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Rhoda S. Pomerantz, MD, MPH, Study chair, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006346
- Sponsor's protocol ID
- SJHCH-TM1
- Other IDs
- CDR0000068177, NCI-V00-1618
- Status last verified
- Mar 2010
- First submitted
- 4 Oct 2000
- Last updated
- 10 Jul 2013
- Results posted
- No
Publications
Nidich SI, Fields JZ, Rainforth MV, Pomerantz R, Cella D, Kristeller J, Salerno JW, Schneider RH. A randomized controlled trial of the effects of transcendental meditation on quality of life in older breast cancer patients. Integr Cancer Ther. 2009 Sep;8(3):228-34. doi: 10.1177/1534735409343000.
PubMed 19815592
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Reduction For Breast Cancer in Women 55 Years of Age or Older: Enhancing Quality of Life and Survival
- ClinicalTrials.gov ID
- NCT00006346
- Acronym / sponsor ID
- SJHCH-TM1
- Keywords
- stage II breast cancer, stage IV breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, psychosocial effects of cancer and its treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Aug 2000
- Study completion
- Sep 2003 (actual)
- First posted
- 4 Sep 2003 (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.
RATIONALE: Transcendental meditation may be an effective way to decrease the amount of stress in older women with breast cancer. It is not yet known if transcendental meditation is more effective than basic breast cancer education in improving quality of life.
PURPOSE: This randomized clinical trialstudies stress reduction in improvingquality of life in older women with stage II, stage III, or stage IV breast cancer.
Detailed description
OBJECTIVES:
- Compare the effects of active stress reduction with transcendental meditation vs basic breast cancer education on quality of life and survival time in older women with stage II, III, or IV breast cancer.
- Determine behavioral mechanisms that may mediate the effects of stress reduction on survival in these patients.
- Determine baseline variables that contribute to predicting survival time in these patients.
OUTLINE: This is a randomized, single blind (to medical staff), multicenter study. Patients are stratified according to age and participation in support groups. Patients with stage IV disease are also stratified according to type of metastases (visceral vs non-visceral) and timing of metastases (first diagnosis vs recurrence). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive usual medical care and instruction on stress reduction using transcendental meditation (TM), which involves a standard 7-step course. Patients attend training for approximately 1-1.5 hours per session for a total of 6 sessions over 1 week, while receiving usual medical care. Patients then practice TM twice a day for 20 minutes. Patients attend group meetings for approximately 90 minutes once or twice monthly for 6 months to ensure proper technique and understanding.
- Arm II: Patients receive usual medical care and basic literature on breast cancer.
Quality of life is assessed at baseline and then every 6 months for up to 3 years.
Patients are followed monthly for up to 2.5 years.
PROJECTED ACCRUAL: Approximately 166 patients (83 per treatment arm) will be accrued for this study within 6 months.
Study design
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| psychosocial assessment and care | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 10 Jul 2013.
- Results publication: PubMed 19815592Nidich SI, Fields JZ, Rainforth MV, Pomerantz R, Cella D, Kristeller J, Salerno JW, Schneider RH. A randomized controlled trial of the effects of transcendental meditation on quality of life in older breast cancer patients. Integr Cancer Ther. 2009 Sep;8(3):228-34. doi: 10.1177/1534735409343000.
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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.
Rhoda S. Pomerantz, MD, MPH study chair
Unity Health Toronto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychosocial assessment and care and quality-of-life assessment in people with Breast Cancer and Psychosocial Effects of Cancer and Its Treatment, run by Unity Health Toronto at 3 sites 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?
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 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006346, 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 10 Jul 2013.