Recruiting

Massage Therapy

Sponsor:

Jill Cole

Code:

NCT07502157

Conditions

Gynecologic Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Massage Therapy

Attention Control

Study Details

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 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.

Conditions

Gynecologic Cancer

Study ID

NCT07502157

Start date

Sep 3, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

placebo comparator: Attention Control, No Massage Therapy

Attention Control, No Massage Therapy

experimental: Massage Therapy

Massage Therapy

Interventions

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.

Attention Control

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

Primary outcome measure

  • Recruitment feasibility [ Time Frame: 6 months ]
  • Retention [ Time Frame: 6 months ]
  • Randomization [ Time Frame: 6 months ]
  • Percentage of accessors successful blinded [ Time Frame: 6 months ]
  • Number of participants that completed 3 or more sessions [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Jill S Cole, MA, LMT, BCMTB

859-323-7087jill.cole1@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Jill S Cole, MA, LMT, BCTMB

859-323-7087jill.cole1@uky.edu

Principal Investigator:

Jill S Cole, MA, LMT, BCTMB

More Information

Sponsor

Jill Cole

Last update posted

Sep 10, 2026

Last verified

Jul, 2026

Keywords

  • Massage therapy
  • Pain
  • Anxiety
  • Cancer
  • Feasibility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-21. This information was provided to ClinicalTrials.gov by Jill Cole on 2026-09-10.