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Reiki Therapy for Gynecological Cancer (Reiki-Brachy Trial)
Phase 2
Recruiting
Led By Lindsay Burt, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Reiki-Brachy Trial Summary
This trial will study the effects of Reiki therapy on people receiving radiation therapy for gynecological cancer.
Who is the study for?
This trial is for adults over 18 with certain gynecological cancers (endometrium, cervix, vagina, or vulva) who are about to receive their first brachytherapy as an outpatient. Participants must understand English/Spanish and be willing to sign consent forms. Those with prior brachytherapy or conditions affecting study compliance cannot join.Check my eligibility
What is being tested?
The study tests if Reiki therapy can improve the well-being of patients during the wait time between device placement and brachytherapy treatment for gynecological cancers. It compares outcomes like anxiety and pain in those receiving Reiki versus usual care before and three months after treatment.See study design
What are the potential side effects?
Reiki therapy is a non-invasive technique involving therapeutic touch, so it typically does not have physical side effects. However, emotional or psychological responses vary by individual.
Reiki-Brachy Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Secondary outcome measures
Comparison between the treatment groups of the change in anxiety from Assessment 1 to Assessment 3 as measured by the Visual Analog Scale - Pain.
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.
Comparison between the treatment groups of the change in pain from Assessment 1 to Assessment 3 as measured by the Visual Analog Scale - Pain.
+1 moreReiki-Brachy Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Reiki TherapyExperimental Treatment1 Intervention
Participants randomized to Arm 1 will receive a session of Reiki therapy during the standard wait time between the placement of the brachytherapy device and their first brachytherapy treatment.
Group II: Standard of CareActive Control1 Intervention
Participants randomized to the standard of care control arm will be asked to remain in a clinic room during the standard waiting period between the placement of the brachytherapy device and the start of brachytherapy treatment. Participants may participate in any activity other than Reiki therapy during this time. Participants may be accompanied by a family member or friend.
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Who is running the clinical trial?
University of UtahLead Sponsor
1,100 Previous Clinical Trials
1,778,833 Total Patients Enrolled
Lindsay Burt, MDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
1 Previous Clinical Trials
30 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer originates from the endometrium, cervix, vagina, or vulva.I have had brachytherapy for a gynecological cancer.I am 18 years old or older.I am qualified to have brachytherapy as an outpatient.I am open to being assigned to either Reiki therapy or standard treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Reiki Therapy
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment still open for participants in this medical research experiment?
"As per clinicaltrials.gov, this research endeavour has ceased participant recruitment; the initial posting was on September 1st 2023 and updates were made through to July 28th of that year. Nevertheless, there are 600 other medical trials in need of volunteers at present."
Answered by AI
To what degree could subjects enrolled in Arm 1 be at risk?
"As Phase 2 trials provide preliminary evidence for safety but no data on efficacy, Arm 1 was evaluated as a 2 in terms of its security profile."
Answered by AI
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