Healing Touch During Chemotherapy Infusions for Women Wit... | NCT00533663

Studies
Healing Touch During Chemotherapy Infusions for Women With Breast Cancer

NCT00533663

Sponsor

Stanford University

Status

Completed

Last Update Posted

Jun 23, 2022Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Healing Touch
Standard care
guided relaxation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
BRSADJ0007	Other Identifier	OnCore

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Sep 20, 2007

First Submission Date that Met QC Criteria

Sep 20, 2007

First Posted Date

Sep 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2022

Last Update Posted Date

Jun 23, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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).	Procedure: Healing Touch Other: Standard care
Standard Care + Guided relaxation	Active Comparator	Guided relaxation every other week (during their infusion).	Other: Standard care Procedure: guided relaxation
standard care only	Active Comparator	Standard care	Other: Standard care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Healing Touch	Procedure	every other week (during their infusion)	Standard Care + Healing Touch (HT)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
FACT-B summary score		Baseline, 6 wks, 14 wks

Secondary Outcomes

Measure	Description	Time Frame
Domain scores for FACT-B; BSI-18; FACIT-Fatigue; nausea measured on a Likert scale		Baseline, 6 wks, 14 wks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:- Stage I or II breast cancer

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

Exclusion Criteria:- Previous chemotherapy exposure

- Concomitant energy-work interventions (HT, Reiki, QiGong, acupuncture).

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kathy Turner, RN, NP	Stanford University	Principal Investigator
Alice "Ellie" Guardino, RN, NP	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014110	Touch
D059039	Standard of Care

Ancestor Terms

ID	Term
D012677	Sensation
D009424	Nervous System Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena
D019984	Quality Indicators, Health Care

Browse Leaves

Not provided

Browse Branches

Not provided