NCT05979610 Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies
| NCT ID | NCT05979610 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Utah |
| Condition | Gynecologic Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-11-14 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 70 participants in total. It began in 2023-11-14 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Subject aged ≥ 18 years. * Pathologically confirmed malignancy of the endometrium, cervix, vagina or vulva. * Eligible to undergo brachytherapy treatment as an outpatient procedure. * Able to read and understand English and/or Spanish. * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. * Willing to participate in either the Reiki therapy or standard of care arm regardless of treatment assignment. Exclusion Criteria: * Prior brachytherapy treatment for a gynecological malignancy. * 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.
Contact & Investigator
Lindsay Burt, MD
PRINCIPAL INVESTIGATOR
Huntsman Cancer Institute/ University of Utah
Frequently Asked Questions
Who can join the NCT05979610 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gynecologic Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05979610 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05979610 currently recruiting?
Yes, NCT05979610 is actively recruiting participants. Contact the research team at David.Samuel@hci.utah.edu for enrollment information.
Where is the NCT05979610 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT05979610 clinical trial?
NCT05979610 is sponsored by University of Utah. The principal investigator is Lindsay Burt, MD at Huntsman Cancer Institute/ University of Utah. The trial plans to enroll 70 participants.