NCT00084123

Brief Summary

The purpose of this study is to evaluate the effects of healing touch and relaxation therapy on cervical cancer patients undergoing chemotherapy and radiation treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

July 10, 2009

Status Verified

July 1, 2009

Enrollment Period

4.6 years

First QC Date

June 7, 2004

Last Update Submit

July 9, 2009

Conditions

Cervix Neoplasms

Keywords

Relaxation TechniquesRadiationDrug TherapyHealing Touch

Outcome Measures

Primary Outcomes (3)

  • natural killer cell cytotoxicity

    Baseline to week 6

  • T-cell counts

    Baseline to week 6

  • side effects

    Baseline to week 6

Secondary Outcomes (4)

  • distress

    Baseline to week 6

  • WBC and RBC

    Baseline to week 6

  • days of treatment delay

    Baseline to week 6

  • salivary cortisol

    Baseline to post-treatment

Study Arms (3)

Healing Touch

EXPERIMENTAL

Healing Touch Therapy

Behavioral: Healing Touch Therapy

Relaxation Therapy

ACTIVE COMPARATOR

Relaxation Therapy

Behavioral: Relaxation Therapy

Standard Care

PLACEBO COMPARATOR

Standard Care

Behavioral: Standard Care

Interventions

Healing Touch TherapyBEHAVIORAL
Healing Touch
Relaxation TherapyBEHAVIORAL
Relaxation Therapy
Standard CareBEHAVIORAL

Standard Care

Standard Care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage Ib1-IVa cervical cancer
  • Treatment with concurrent chemotherapy and radiation at the University of Iowa Hospitals and Clinics

You may not qualify if:

  • Immunosuppressive disorders
  • Use of immunosuppressive medications
  • Transplant recipient
  • Metastatic or recurrent cervical cancer
  • History of any other type of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Relaxation TherapyStandard of Care

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Susan K Lutgendorf, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 7, 2004

First Posted

June 8, 2004

Study Start

September 1, 2002

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

July 10, 2009

Record last verified: 2009-07

Locations

US(1)