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NCT Number: NCT07502157

Massage, Oncology, Pain, Anxiety, Feasibility

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.

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Key information

Conditions

Gynecologic Cancer Anxiety Disorders Mental Disorders Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location contact

Jill S Cole, MA, LMT, BCTMB

CONTACT

[email protected]

859-323-7087

Jill S Cole, MA, LMT, BCTMB

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Massage therapy

Procedure

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 Control

Procedure

Massage therapist sits with gynecologic patient receiving an infusion asking questions for no more than 15 minutes.

Primary outcomes

  1. Recruitment feasibility

    Time frame: 6 months

    Number of participants enrolled within the recruitment period.

  2. Retention

    Time frame: 6 months

    Number of participants completing the study.

  3. Randomization

    Time frame: 6 months

    Number of participants randomized

  4. Percentage of accessors successful blinded

    Time frame: 6 months

    Assessors will be answering yes or no to the questionnaire and percentage will be calculated.

  5. Number of participants that completed 3 or more sessions

    Time frame: 6 months

    Adherence is defined by participant completing 3 or more sessions.

Secondary outcomes

  1. Change in Defense and Veterans Pain Rating Scale (DVPRS)

    Time frame: Pre and post infusion therapy treatment (Up to 9 weeks)

    DVPRS ranges from 0-10. 0 being no pain and 10 being worst pain of patient's life.

  2. Change in State-Trait Anxiety Inventory (STAI)

    Time frame: Pre and post infusion therapy treatment (Up to 9 weeks)

    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.

  3. Temporal Summation, Pain Threshold using von Frey Monofilaments

    Time frame: Pre and Post infusion therapy treatment (Up to 9 weeks)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jill S Cole, MA, LMT, BCMTB

CONTACT

[email protected]

859-323-7087

Sponsors and collaborators

Lead sponsor

Jill Cole

Other

Collaborators

  • Massage Therapy Foundation

Registry information

Official study title

The Impact of Massage Therapy on Pain and Anxiety of Patients With Gynecologic Cancer While Receiving Infusion Treatment (IMPACT)

Acronym: IMPACT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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