Gynecologic CancerIMPACTNCT07502157
Massage, Oncology, Pain, Anxiety, Feasibility
A study testing Massage Therapy in people with Gynecologic Cancer, run by Jill Cole at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Massage Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient with gynecologic cancer that has received infusion therapy anytime within the past 2 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
Jill S Cole, MA, LMT, BCTMB, 859-323-7087, jill.cole1@uky.edu
Jill S Cole, MA, LMT, BCTMB
About this study
Official title: The Impact of Massage Therapy on Pain and Anxiety of Patients With Gynecologic Cancer While Receiving Infusion Treatment (IMPACT)
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.
Read more
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.
- Conditions
- Gynecologic Cancer
- Being tested
- Massage Therapy, Attention Control
- Keywords
- Massage therapy, Pain, Anxiety, Cancer, Feasibility
- Medical subject headings
- Pain, Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage TherapyProcedure or surgery
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.
Attention ControlProcedure or surgery
Massage therapist sits with gynecologic patient receiving an infusion asking questions for no more than 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Attention Control, No Massage Therapy | Placebo comparator | Attention Control, No Massage Therapy Receives: Procedure: Attention Control |
| Massage Therapy | Experimental | Massage Therapy Receives: Procedure: Massage Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility
Number of participants enrolled within the recruitment period.
Measured: 6 months
Retention
Number of participants completing the study.
Measured: 6 months
Randomization
Number of participants randomized
Measured: 6 months
Percentage of accessors successful blinded
Assessors will be answering yes or no to the questionnaire and percentage will be calculated.
Measured: 6 months
Number of participants that completed 3 or more sessions
Adherence is defined by participant completing 3 or more sessions.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Pre and Post infusion therapy treatment (Up to 9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start3 Sep 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jill Cole
- Sponsor type
- University, hospital or other
- Collaborators
- Massage Therapy Foundation
- Responsible party
- Sponsor-investigator, Jill Cole, University of Kentucky
- Investigators
- Jill S Cole, MA, LMT, BCTMB, Principal investigator, University of Kentucky, Integrative Medicine and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502157
- Sponsor's protocol ID
- 107597
- Acronym
- IMPACT
- Status last verified
- Jul 2026
- First submitted
- 16 Mar 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Massage Therapy on Pain and Anxiety of Patients With Gynecologic Cancer While Receiving Infusion Treatment (IMPACT)
- ClinicalTrials.gov ID
- NCT07502157
- Acronym / sponsor ID
- IMPACT / 107597
- Conditions
- Gynecologic Cancer
- Keywords
- Massage therapy, Pain, Anxiety, Cancer, Feasibility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jill ColeUniversity, hospital or other
- Collaborators
- Massage Therapy Foundation
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Control, No Massage Therapy | Placebo comparator | Procedure: Attention ControlAttention Control, No Massage Therapy |
| Massage Therapy | Experimental | Procedure: Massage TherapyMassage Therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient with gynecologic cancer that has received infusion therapy anytime within the past 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage TherapyGynecologic 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. | Procedure or surgery | Massage Therapy |
| Attention ControlMassage therapist sits with gynecologic patient receiving an infusion asking questions for no more than 15 minutes. | Procedure or surgery | Attention Control, No Massage Therapy |
Primary outcome
Recruitment feasibility
Time frame: 6 months
Number of participants enrolled within the recruitment period.
Retention
Time frame: 6 months
Number of participants completing the study.
Randomization
Time frame: 6 months
Number of participants randomized
Percentage of accessors successful blinded
Time frame: 6 months
Assessors will be answering yes or no to the questionnaire and percentage will be calculated.
Number of participants that completed 3 or more sessions
Time frame: 6 months
Adherence is defined by participant completing 3 or more sessions.
3 secondary outcomes
Change in Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: Pre and post infusion therapy treatment (Up to 9 weeks)
Change in State-Trait Anxiety Inventory (STAI)
Time frame: Pre and post infusion therapy treatment (Up to 9 weeks)
Temporal Summation, Pain Threshold using von Frey Monofilaments
Time frame: Pre and Post infusion therapy treatment (Up to 9 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jill S Cole, MA, LMT, BCTMB principal investigator
University of Kentucky, Integrative Medicine and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage Therapy in people with Gynecologic Cancer, run by Jill Cole at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jill S Cole, MA, LMT, BCMTB (859-323-7087, jill.cole1@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.