Massage, Oncology, Pain, Anxiety, Feasibility

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Jill Cole
Study ID
NCT07502157
Status
Not Yet Recruiting

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Conditions

  • Gynecologic Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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.
  • Attention Control — PROCEDURE
    Massage therapist sits with gynecologic patient receiving an infusion asking questions for no more than 15 minutes.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Placebo Comparator: Attention Control, No Massage Therapy
    Attention Control, No Massage Therapy
  • Experimental: Massage Therapy
    Massage Therapy

Primary Outcome Measure

Recruitment feasibility [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506
Jill S Cole, MA, LMT, BCTMB
[email protected]
859-323-7087
Jill S Cole, MA, LMT, BCTMB (PRINCIPAL_INVESTIGATOR)

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By research site
University of Kentucky· Lexington, KY

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