Healing Touch During Chemotherapy Infusions for Women With Breast Cancer

June 16, 2022 updated by: Stanford University
To study if Healing Touch is effective during chemotherapy treatment for breast cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard Care + Healing Touch (HT)
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
every other week (during their infusion)
Other: Standard care
Adriamycin, cyclophosphamide, and paclitaxel administered as standard of care
Active Comparator: Standard Care + Guided relaxation
Guided relaxation every other week (during their infusion).
Other: Standard care
Adriamycin, cyclophosphamide, and paclitaxel administered as standard of care
Procedure: guided relaxation
Active Comparator: standard care only
Standard care
Other: Standard care
Adriamycin, cyclophosphamide, and paclitaxel administered as standard of care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Kathy Turner, RN, NP, Stanford University
  • Principal Investigator: Alice "Ellie" Guardino, RN, NP, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

September 20, 2007

First Submitted That Met QC Criteria

September 20, 2007

First Posted (Estimate)

September 21, 2007

Study Record Updates

Last Update Posted (Actual)

June 23, 2022

Last Update Submitted That Met QC Criteria

June 16, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-07696
  • BRSADJ0007 (Other Identifier: OnCore)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Healing Touch

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe