RECRUITING

Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this open label, randomized, controlled clinical trial is to assess the benefits of providing Reiki therapy to subjects receiving their first brachytherapy treatment for gynecological malignancies. Participants will either receive a session of Reiki therapy or usual care during the standard wait time between the placement of the brachytherapy device and brachytherapy treatment. Questionnaires will be administered at various time points on the day of the participant's first brachytherapy treatment as well as at the three month follow-up time point. Researchers will compare the intervention (Reiki therapy) and control (usual care) groups to assess the impact of the Reiki therapy on anxiety, pain, state anxiety, depression, and physiological measurements.

Official Title

Reiki-Brachy: An Interventional Treatment Trial Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies

Quick Facts

Study Start:2023-10-09
Study Completion:2027-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05979610

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject aged ≥ 18 years.
  2. * Pathologically confirmed malignancy of the endometrium, cervix, vagina or vulva.
  3. * Eligible to undergo brachytherapy treatment as an outpatient procedure.
  4. * Able to read and understand English and/or Spanish.
  5. * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
  6. * Willing to participate in either the Reiki therapy or standard of care arm regardless of treatment assignment.
  1. * Prior brachytherapy treatment for a gynecological malignancy.
  2. * Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.

Contacts and Locations

Study Contact

David Samuel
CONTACT
801-587-4713
David.Samuel@hci.utah.edu

Principal Investigator

Lindsay Burt, MD
PRINCIPAL_INVESTIGATOR
Huntsman Cancer Institute/ University of Utah

Study Locations (Sites)

Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: University of Utah

  • Lindsay Burt, MD, PRINCIPAL_INVESTIGATOR, Huntsman Cancer Institute/ University of Utah

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 Registration Dates

Study Start Date2023-10-09
Study Completion Date2027-04-01

Study Record Updates

Study Start Date2023-10-09
Study Completion Date2027-04-01

Terms related to this study

Keywords Provided by Researchers

  • Reiki

Additional Relevant MeSH Terms

  • Gynecologic Neoplasm
  • Brachytherapy
  • Therapeutic Touch
  • Endometrial Cancer
  • Cervical Cancer
  • Vaginal Cancer
  • Vulvar Cancer