Breast CancerNCT00533663
Healing Touch During Chemotherapy Infusions for Women With Breast Cancer
A study testing Healing Touch and guided relaxation in people with Breast Cancer, run by Stanford University at 1 site in United States.
Trial summary
To study if Healing Touch is effective during chemotherapy 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 and guided relaxation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Aug 2010
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-operative
- Concurrent enrollment on a treatment protocol of 8 weeks of adriamycin + cyclophosphamide given every other week followed by 8 weeks of paclitaxel given every other week
- ECOG Performance Status: 0 to 2
- Speak and read English
Who cannot join
- Concomitant energy-work interventions (HT, Reiki, QiGong, acupuncture).
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
To study if Healing Touch is effective during chemotherapy treatment for breast cancer
Read the detailed description
To study the effectiveness of Healing Touch provided during chemotherapy infusions on the experience of women undergoing treatment for breast cancer. Healing Touch (HT) is a gentle, non-invasive form of energy-balancing work that promotes relaxation and can help manage the side effects of chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Healing Touch, Standard care, guided relaxation
- 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
every other week (during their infusion)
Standard careOther
Adriamycin, cyclophosphamide, and paclitaxel administered as standard of care
guided relaxationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard Care + Healing Touch (HT) | Experimental | A a gentle, non-invasive form of energy-balancing work that promotes relaxation and can help manage the side effects of chemotherapy. It occurs every other week (during their infusion). Receives: Procedure: Healing Touch; Other: Standard care |
| Standard Care + Guided relaxation | Active comparator | Guided relaxation every other week (during their infusion). Receives: Other: Standard care; Procedure: guided relaxation |
| standard care only | Active comparator | Standard care Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT-B summary score
Measured: Baseline, 6 wks, 14 wks
Secondary outcomes (1)
Domain scores for FACT-B; BSI-18; FACIT-Fatigue; nausea measured on a Likert scale
Measured: Baseline, 6 wks, 14 wks
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 startApr 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathy Turner, RN, NP, Principal investigator, Stanford UniversityAlice "Ellie" Guardino, RN, NP, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533663
- Sponsor's protocol ID
- IRB-07696
- Other IDs
- BRSADJ0007
- Status last verified
- Jun 2022
- First submitted
- 20 Sep 2007
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Touch During Chemotherapy Infusions for Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT00533663
- Acronym / sponsor ID
- IRB-07696
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Sep 2007 (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.
To study if Healing Touch is effective during chemotherapy treatment for breast cancer
Detailed description
To study the effectiveness of Healing Touch provided during chemotherapy infusions on the experience of women undergoing treatment for breast cancer. Healing Touch (HT) is a gentle, non-invasive form of energy-balancing work that promotes relaxation and can help manage the side effects of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care + Healing Touch (HT) | Experimental | Procedure: Healing Touch, Other: Standard careA a gentle, non-invasive form of energy-balancing work that promotes relaxation and can help manage the side effects of chemotherapy. It occurs every other week (during their infusion). |
| Standard Care + Guided relaxation | Active comparator | Other: Standard care, Procedure: guided relaxationGuided relaxation every other week (during their infusion). |
| standard care only | Active comparator | Other: Standard careStandard care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Post-operative
- Concurrent enrollment on a treatment protocol of 8 weeks of adriamycin + cyclophosphamide given every other week followed by 8 weeks of paclitaxel given every other week
- ECOG Performance Status: 0 to 2
- Speak and read English
Key exclusion criteria (1 listed)
- Concomitant energy-work interventions (HT, Reiki, QiGong, acupuncture).
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 Touchevery other week (during their infusion) | Procedure or surgery | Standard Care + Healing Touch (HT) |
| Standard careAdriamycin, cyclophosphamide, and paclitaxel administered as standard of care | Other | Standard Care + Guided relaxation, Standard Care + Healing Touch (HT), standard care only |
| guided relaxation | Procedure or surgery | Standard Care + Guided relaxation |
Primary outcome
FACT-B summary score
Time frame: Baseline, 6 wks, 14 wks
1 secondary outcome
Domain scores for FACT-B; BSI-18; FACIT-Fatigue; nausea measured on a Likert scale
Time frame: Baseline, 6 wks, 14 wks
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 23 Jun 2022.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Kathy Turner, RN, NP principal investigator
Stanford University
Alice "Ellie" Guardino, RN, NP 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 and guided relaxation 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?
The sponsor lists 4 inclusion and 1 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 23 Jun 2022. 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?
FACT-B summary score (time frame: Baseline, 6 wks, 14 wks). 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 23 Jun 2022.