Quality of Life Interventions During Cervical Cancer Treatment

May 25, 2021 updated by: Susan Lutgendorf, University of Iowa
The proposed project will examine the effects of a healing touch intervention in women receiving chemotherapy and radiation for advanced cervical cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients receiving chemoradiation for cervical cancer are at risk for distress, chemoradiation-related side effects, and immunosuppression. This prospective randomized clinical trial proposes to examine the effects of a complementary therapy, Healing Touch (HT), versus relaxation training (RT) and usual care (UC) for (1) supporting cellular immunity, (2) improving mood and quality of life (QOL), and (3) reducing treatment-associated toxicities and treatment delay in cervical cancer patients receiving chemoradiation.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with stage I-IVa cervical cancer pursuing concurrent chemotherapy and radiation therapy.

Exclusion Criteria:

  • Greater than Stage IVa cervical cancer
  • Metastatic or recurrent cervical cancer
  • Patients receiving only chemotherapy or only radiation therapy
  • History of cancer of any site
  • History of a transplant
  • Diagnosed with any immunosupressive disorder (HIV, AIDS).

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Relaxation training following daily radiation
All relaxation sessions will be given individually, and will be provided by trained nurses or research assistants. Patients receiving relaxation will learn exercises to release tension through muscle relaxation, breathing, and imagery
Other: Questionnaire administration
Behavioral: Relaxation training
Muscle relaxation training
Other Names:
  • Relaxation
Other: Ancillary studies
Subjects in all groups will give 4 blood samples during the study
Other Names:
  • Blood draw
Experimental: Healing touch therapy following daily radiation
All Healing Touch sessions will be given individually, and will be provided by trained nurses or research assistants. Patients receiving Healing Touch will receive a series of standardized therapeutic techniques designed to promote optimal flow of energy throughout the body.
Other: Questionnaire administration
Other: Ancillary studies
Subjects in all groups will give 4 blood samples during the study
Other Names:
  • Blood draw
Behavioral: Therapeutic touch
Healing Touch (HT) therapy
Other Names:
  • Healing touch
Active Comparator: No intervention
The no intervention group will receive no special intervention other than standard medical care, which includes the regular medical care given by the patient's physician and health care professionals.
Other: Questionnaire administration
Other: Ancillary studies
Subjects in all groups will give 4 blood samples during the study
Other Names:
  • Blood draw

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in natural killer cell cytotoxicity (NKCC)
Time Frame: 6 weeks

Compare change in natural killer cell cytotoxicity of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw.

Fresh peripheral blood mononuclear cells tested for cytolytic activity against the NK-sensitive K562 cells and the NK-resistant LAK-sensitive ZKBL cells in a standard 4-h 51Chromium- release assay.
6 weeks
Number of chemoradiation-related toxicities
Time Frame: 6 weeks
Compare number of reported side effects of participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care as measured by the Common Toxicity Criteria Manual Version 2.0
6 weeks
Number of days of treatment delay due to chemoradiation-related toxicities
Time Frame: 6 weeks
Compare number of days in treatment delay due to chemoradiation-related toxicity for participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care
6 weeks
Change in participant reports of depression
Time Frame: 6 weeks
Compare changes in depression scores of participants receiving HT to participants receiving relaxation training or usual care during radiation and chemotherapy as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) in which higher scores indicate worse depression (range 0-60)
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in participant reports of anxiety
Time Frame: 6 weeks
Compare changes in reported anxiety of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Profile of Mood States- Anxiety Subscale (POMS-SF) (range 0-28)
6 weeks
Change in white blood cell counts
Time Frame: 6 weeks

Compare change in white blood cell counts of participants receiving HT during radiation and chemotherapy vs. patients receiving relaxation training or usual care during this time

hemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw.
6 weeks
Change in red blood cell counts
Time Frame: 6 weeks
Compare change in red blood cell counts of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw.
6 weeks
Change in participant reports of quality of life
Time Frame: 6 weeks
Compare change in reported quality of life of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Functional assessment of Cancer therapies (FACT). Higher scores indicate better quality of life. Range= (0-136).
6 weeks
Change in participant reports of fatigue
Time Frame: 6 weeks
Compare reported fatigue of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Fatigue Severity Inventory (FSI). Mean fatigue intensity (range 0-10) with higher scores indicating more fatigue, and fatigue duration in days last week experiencing fatigue (0-7 days) with greater number of days indicating greater fatigue duration.
6 weeks
Change in metabolomic measures
Time Frame: 6 weeks
Compare metabolic profile of participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care. Samples were assayed using Ultrahigh Performance Liquid Chromatography-Tandem Mass Spectroscopy (UPLC-MS/MS). The metabolomic profiling analysis measures the quantity of specific compounds in the plasma vs. a platform of 844 known metabolites in a commercial platform powered by Metabolon, Inc. For any specific metabolite, higher levels indicates greater presence of the metabolite.
6 weeks

Collaborators and Investigators

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

Sponsor

University of Iowa

Investigators

  • Principal Investigator: Susan Lutgendorf, PhD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 4, 2001

Primary Completion (Actual)

March 15, 2008

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

May 27, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200105058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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