Clinical trial NCT05979610: Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies
Official title: Reiki-Brachy: An Interventional Treatment Trial Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gynecologic Neoplasm
Brachytherapy
Therapeutic Touch
Endometrial Cancer
Cervical Cancer
Vaginal Cancer
Vulvar Cancer
Keywords: Reiki
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects who meet all criteria for enrollment will be randomly assigned to receive Reiki therapy (Arm 1) or usual care (Arm 2) using block randomization. Subjects will be randomized through the OnCore system in a 1:1 ratio to Arm 1 or Arm 2 and stratified by treatment type (multichannel vaginal cylinder (MCVC) and vaginal cylinder vs. all other treatment modalities). Randomization will not be blinded.
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Comparison between the treatment groups of the change in anxiety from Assessment 1 to Assessment 3 as measured by the 6-item Spielberger State Anxiety Scale.
timeFrame: 4 months
Secondary outcomes:
measure: Comparison between the treatment groups of the change in pain from Assessment 1 to Assessment 3 as measured by the Visual Analog Scale - Pain.
timeFrame: 4 months
measure: Comparison between the treatment groups of the change in anxiety from Assessment 2 to Assessment 3 as measured by the 6-item Spielberger State Anxiety Scale.
timeFrame: 4 months
measure: Comparison between the treatment groups of the change in anxiety from Assessment 1 to Assessment 3 as measured by the Visual Analog Scale - Pain.
timeFrame: 4 months
measure: Comparison between the treatment groups of the change in state anxiety and depression from Assessment 1 to three month post-radiation as measured by the Hospital Anxiety and Depression Scale.
timeFrame: 4 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute/ University of Utah
name: Lindsay Burt, MD
role: PRINCIPAL_INVESTIGATOR
References: