Quality of Life Interventions During Cervical Cancer Treatment

NCT ID: NCT04905576

Last Updated: 2021-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-04

Study Completion Date

2014-07-31

Brief Summary

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The proposed project will examine the effects of a healing touch intervention in women receiving chemotherapy and radiation for advanced cervical cancer.

Detailed Description

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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.

Conditions

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Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are randomized to relaxation, healing touch, or standard care arms of the study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Relaxation training

Intervention Type BEHAVIORAL

Muscle relaxation training

Questionnaire administration

Intervention Type OTHER

Ancillary studies

Intervention Type OTHER

Subjects in all groups will give 4 blood samples during the study

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.

Group Type EXPERIMENTAL

Therapeutic touch

Intervention Type BEHAVIORAL

Healing Touch (HT) therapy

Questionnaire administration

Intervention Type OTHER

Ancillary studies

Intervention Type OTHER

Subjects in all groups will give 4 blood samples during the study

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.

Group Type ACTIVE_COMPARATOR

Questionnaire administration

Intervention Type OTHER

Ancillary studies

Intervention Type OTHER

Subjects in all groups will give 4 blood samples during the study

Interventions

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Relaxation training

Muscle relaxation training

Intervention Type BEHAVIORAL

Therapeutic touch

Healing Touch (HT) therapy

Intervention Type BEHAVIORAL

Questionnaire administration

Intervention Type OTHER

Ancillary studies

Subjects in all groups will give 4 blood samples during the study

Intervention Type OTHER

Other Intervention Names

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Relaxation Healing touch Blood draw

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Susan Lutgendorf

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan Lutgendorf, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

References

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Lutgendorf SK, Mullen-Houser E, Russell D, Degeest K, Jacobson G, Hart L, Bender D, Anderson B, Buekers TE, Goodheart MJ, Antoni MH, Sood AK, Lubaroff DM. Preservation of immune function in cervical cancer patients during chemoradiation using a novel integrative approach. Brain Behav Immun. 2010 Nov;24(8):1231-40. doi: 10.1016/j.bbi.2010.06.014. Epub 2010 Jun 30.

Reference Type BACKGROUND
PMID: 20600809 (View on PubMed)

Hart LK, Freel MI, Haylock PJ, Lutgendorf SK. The use of healing touch in integrative oncology. Clin J Oncol Nurs. 2011 Oct;15(5):519-25. doi: 10.1188/11.CJON.519-525.

Reference Type BACKGROUND
PMID: 21951738 (View on PubMed)

Other Identifiers

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200105058

Identifier Type: -

Identifier Source: org_study_id

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