Massage, Oncology, Pain, Anxiety, Feasibility
NCT07502157 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-05-11
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
Interventions
- 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.
- PROCEDURE
-
Attention Control
Massage therapist sits with gynecologic patient receiving an infusion asking questions for no more than 15 minutes.
Sponsors & Collaborators
-
Massage Therapy Foundation
collaborator OTHER -
Jill Cole
lead OTHER
Principal Investigators
-
Jill S Cole, MA, LMT, BCTMB · University of Kentucky, Integrative Medicine and Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-01
- Primary Completion
- 2026-10-31
- Completion
- 2026-10-31
Countries
- United States
Study Locations
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