Healing Touch During Chemotherapy Infusions for Women With Breast Cancer

NCT00533663 | Completed

• 2 other identifiers: IRB-07696BRSADJ0007
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

To study if Healing Touch is effective during chemotherapy treatment for breast cancer

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• FACT-B summary score

  Baseline, 6 wks, 14 wks

Secondary Outcomes (1)

• Domain scores for FACT-B; BSI-18; FACIT-Fatigue; nausea measured on a Likert scale

  Baseline, 6 wks, 14 wks

Study Arms (3)

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

Healing Touch PROCEDURE

every other week (during their infusion)

Standard Care + Healing Touch (HT)

Standard care OTHER

Adriamycin, cyclophosphamide, and paclitaxel administered as standard of care

Standard Care + Guided relaxation; Standard Care + Healing Touch (HT); standard care only

guided relaxation PROCEDURE

Standard Care + Guided relaxation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Touch; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kathy Turner, RN, NP

  Stanford University

  PRINCIPAL INVESTIGATOR

• Alice "Ellie" Guardino, RN, NP

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 21, 2007
• Study Start: April 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 23, 2022

Record last verified: 2022-06

Locations

US (1)