Massage, Oncology, Pain, Anxiety, Feasibility

NCT07502157 | Not Yet Recruiting

• 1 other identifier: 107597
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Massage therapy; Pain; Anxiety; Cancer; Feasibility

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Change in Defense and Veterans Pain Rating Scale (DVPRS)

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

• Change in State-Trait Anxiety Inventory (STAI)

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

• Temporal Summation, Pain Threshold using von Frey Monofilaments

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

Study Arms (2)

Attention Control, No Massage Therapy

PLACEBO COMPARATOR

Attention Control, No Massage Therapy

Procedure: Attention Control

Massage Therapy

EXPERIMENTAL

Massage Therapy

Procedure: Massage Therapy

Interventions

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.

Massage Therapy

Attention Control PROCEDURE

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

Attention Control, No Massage Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jill Cole: lead
• Massage Therapy Foundation: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Neoplasms

Interventions

Massage

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Jill S Cole, MA, LMT, BCTMB

  University of Kentucky, Integrative Medicine and Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill S Cole, MA, LMT, BCMTB

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 30, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)