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Clinical Trial NCT07502157 (IMPACT) for Gynecologic Cancer is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Massage, Oncology, Pain, Anxiety, Feasibility (IMPACT) 24 Randomized Academic-Led
Clinical Trial NCT07502157 (IMPACT) is an interventional study for Gynecologic Cancer and is currently not yet recruiting. Enrollment is planned to begin on April 1, 2026 and continue until the study accrues 24 participants. Led by Jill Cole, this study is expected to complete by October 1, 2026. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief Summary
The goal of this clinical trial is to determine the feasibility of studying massage therapy in patients with gynecologic cancers while receiving infusion treatments. The central hypothesis is that it is feasible to implement a massage intervention study in an infusion center at an academic hospital, and measure pain and anxiety in patients with gynecological cancer. The main questions it aims to answer are:
Can inve...
Show MoreOfficial Title
The Impact of Massage Therapy on Pain and Anxiety in Patients With Gynecologic Cancer While Receiving Infusion
Conditions
Gynecologic CancerOther Study IDs
- IMPACT
- 107597
NCT ID Number
Start Date (Actual)
2026-04
Last Update Posted
2026-03-30
Completion Date (Estimated)
2026-10
Enrollment (Estimated)
24
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Massage therapy
Pain
Anxiety
Cancer
Feasibility
Pain
Anxiety
Cancer
Feasibility
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Placebo ComparatorAttention Control, No Massage Therapy Attention Control, No Massage Therapy | Attention Control Massage therapist sits with gynecologic patient receiving an infusion asking questions for no more than 15 minutes. |
ExperimentalMassage Therapy Massage Therapy | Massage therapy Gynecologic patient receiving an infusion will receive massage therapy for 15-20 minutes. The patient will have a choice of a hand, foot, or posterior neck and shoulder Swedish massage. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Recruitment feasibility | Number of participants enrolled within the recruitment period. | 6 months |
Retention | Number of participants completing the study. | 6 months |
Randomization | Number of participants randomized | 6 months |
Percentage of accessors successful blinded | Assessors will be answering yes or no to the questionnaire and percentage will be calculated. | 6 months |
Number of participants that completed 3 or more sessions | Adherence is defined by participant completing 3 or more sessions. | 6 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in Defense and Veterans Pain Rating Scale (DVPRS) | DVPRS ranges from 0-10. 0 being no pain and 10 being worst pain of patient's life. | Pre and post infusion therapy treatment (Up to 9 weeks) |
Change in State-Trait Anxiety Inventory (STAI) | The STAI-6 will be used to measure and collect a self-reported anxiety score from the study participant pre/post intervention. The questions asked are, "I feel calm; I am tense; I feel upset; I am relaxed; I feel content; I am worried." The answers are on a scale of 1-4, with 1=Almost never, 2=Somewhat, 3=Moderately, 4=Very much. | Pre and post infusion therapy treatment (Up to 9 weeks) |
Temporal Summation, Pain Threshold using von Frey Monofilaments | Using a 180 gram von Frey filament, threshold for pain will be used by performing temporal summation wind-up method. The wind-up method will be used to measure pain pre/post intervention, of each study participant, during all three intervention sessions. Each assessor will use the thenar eminence (thumb pad) of the participate, applying pressure straight down, until a "C" with the filament is formed. After the "C" is formed on the participant, the assessor will ask, on a scale of 0-10 (zero being no pain and 10 being the worst pain imaginable) what their perceived rate of pain intensity was. The assessor will then use a stopwatch on their phone to wait 30 seconds and then apply the same filament on the same thenar eminence 10 times in the same area, at a rate of 60hz or 1 per second (still making a "C"). The assessor will then ask, on a scale of 0-10, (zero being no pain and 10 being the worst pain imaginable) what their perceived rate of pain intensity. | Pre and Post infusion therapy treatment (Up to 9 weeks) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
- Patients with gynecologic cancer receiving active treatment of infusion, including but not limited to chemotherapy, immunotherapy, antibiotics, and blood.
- Patients with gynecological cancer undergoing an infusion for the first time.
- Patient with gynecologic cancer that has received infusion therapy anytime within the past 2 years.
Jill ColeMassage Therapy FoundationStudy Responsible Party
Jill Cole, Sponsor-Investigator, Principal Investigator, University of Kentucky
Study Central Contact
Contact: Jill S Cole, MA, LMT, BCMTB, 859-323-7087, [email protected]
1 Study Locations in 1 Countries
Kentucky
University of Kentucky, Lexington, Kentucky, 40506, United States
Jill S Cole, MA, LMT, BCTMB, Contact, 859-323-7087, [email protected]
Jill S Cole, MA, LMT, BCTMB, Principal Investigator