Massage, Oncology, Pain, Anxiety, Feasibility (IMPACT)

The Impact of Massage Therapy on Pain and Anxiety in Patients With Gynecologic Cancer While Receiving Infusion

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 investigators evaluate feasibility to conduct a study from a design standpoint? Can investigators assess the use of randomization, blinding of assessors, potential to control the study with an attention group, and recruitment/retention processes? Can investigators successfully collect outcome measures of pain and anxiety, pre/post intervention? Researchers will investigate degree of resources needed, such as massage therapists, assessors, and timing of delivery intervention. Assess positive/negative effects on target population determining massage modality and anatomical location. Researchers will compare massage therapy to an attention control group, to see if massage therapy works to treat pain and anxiety in patients with cancer.

Establish variability in outcome measures.

Participants will:

Be randomized and receive either massage therapy or attention control over the course of three consecutive infusion therapy treatments. Each infusion therapy treatment occurs every 2-4 weeks.

Study Overview

• Status: Not yet recruiting
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Procedure: Attention Control; Procedure: Massage Therapy

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jill S Cole, MA, LMT, BCMTB; Phone Number: 859-323-7087; Email: jill.cole1@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky
      • Contact: Jill S Cole, MA, LMT, BCTMB; Phone Number: 859-323-7087; Email: jill.cole1@uky.edu
      • Principal Investigator: Jill S Cole, MA, LMT, BCTMB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patient with gynecologic cancer that has received infusion therapy anytime within the past 2 years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Attention Control, No Massage Therapy	Procedure: Attention Control; Massage therapist sits with gynecologic patient receiving an infusion asking questions for no more than 15 minutes.
Experimental: Massage Therapy	Procedure: 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.

What is the study measuring?

Primary 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

Secondary Outcome Measures

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)

Collaborators and Investigators

• Sponsor: Jill Cole
• Collaborators: Massage Therapy Foundation
• Investigators: Principal Investigator: Jill S Cole, MA, LMT, BCTMB, University of Kentucky, Integrative Medicine and Health

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Feasibility; Pain; Anxiety; Massage therapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Neoplasms; Anxiety Disorders; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Therapy, Soft Tissue; Musculoskeletal Manipulations; Massage
• Other Study ID Numbers: 107597

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No