Breast CancerNCT00533780
Effect of Healing Touch on the Experience of Women Undergoing Treatment for Breast Cancer
A study testing Healing Touch in people with Breast Cancer, run by Stanford University at 1 site in United States.
Trial summary
To learn what effect, if any, Healing Touch (a gentle, non-invasive form of energy work that promotes relaxation and can help manage the side effects of chemotherapy and radiation), has on physical symptoms, mood, and qualify of life for women undergoing treatment for breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Healing Touch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Aug 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:- Patients undergoing treatment for breast cancer.
- Age 18 or over.
- Participants in Healing Partners Program. Exclusion Criteria:- Patients not under the care of a physician.
- Patients not able to come to regular healing touch sessions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
To learn what effect, if any, Healing Touch (a gentle, non-invasive form of energy work that promotes relaxation and can help manage the side effects of chemotherapy and radiation), has on physical symptoms, mood, and qualify of life for women undergoing treatment for breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Healing Touch
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healing TouchProcedure or surgery
A gentle, non-invasive form of energy-balancing work that promotes relaxation and can help manage the side effects of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| MRI high resolution 3D diffusion | Experimental | Total duration is about 8 minutes. Receives: Procedure: Healing Touch |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT-B Quality of Life Score
Final scores (FACT-B-Total) of all subscales range from 0 to 148, where 148 represents the most favorable score and accordingly a highest QoL.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startJan 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Avon Foundation
- Responsible party
- Sponsor
- Investigators
- Lynn M Westphal, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533780
- Sponsor's protocol ID
- BRSADJ0003
- Other IDs
- 95738, 14064
- Status last verified
- Apr 2023
- First submitted
- 20 Sep 2007
- Last updated
- 19 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Healing Touch on the Experience of Women Undergoing Treatment for Breast Cancer
- ClinicalTrials.gov ID
- NCT00533780
- Acronym / sponsor ID
- BRSADJ0003
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Avon Foundation
- Study start
- Jan 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 21 Sep 2007 (estimated)
- Results
- Posted 19 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn what effect, if any, Healing Touch (a gentle, non-invasive form of energy work that promotes relaxation and can help manage the side effects of chemotherapy and radiation), has on physical symptoms, mood, and qualify of life for women undergoing treatment for breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI high resolution 3D diffusion | Experimental | Procedure: Healing TouchTotal duration is about 8 minutes. |
Who may qualify
- Ages
- 18 to 70 years
- 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 |
|---|---|---|
| Healing TouchA gentle, non-invasive form of energy-balancing work that promotes relaxation and can help manage the side effects of chemotherapy. | Procedure or surgery | MRI high resolution 3D diffusion |
Primary outcome
FACT-B Quality of Life Score
Time frame: month 6
Final scores (FACT-B-Total) of all subscales range from 0 to 148, where 148 represents the most favorable score and accordingly a highest QoL.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lynn M Westphal principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healing Touch in people with Breast Cancer, run by Stanford University 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?
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 19 Jan 2024. 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?
Yes. Results are posted in the registry (first posted 19 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
FACT-B Quality of Life Score (time frame: month 6). 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 19 Jan 2024.