Massage, Oncology, Pain, Anxiety, Feasibility

Purpose

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.

Condition

  • Gynecologic Cancer

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Attention Control, No Massage Therapy
Attention Control, No Massage Therapy
  • Procedure: Attention Control
    Massage therapist sits with gynecologic patient receiving an infusion asking questions for no more than 15 minutes.
Experimental
Massage Therapy
Massage Therapy
  • 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.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40506
Contact:
Jill S Cole, MA, LMT, BCTMB
859-323-7087
jill.cole1@uky.edu

More Details

NCT ID
NCT07502157
Status
Recruiting
Sponsor
Jill Cole

Study Contact

Jill S Cole, MA, LMT, BCMTB
859-323-7087
jill.cole1@uky.edu