Massage, Oncology, Pain, Anxiety, Feasibility

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-85
SponsorJill Cole

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Massage Therapy
  • Attention Control

Treatment groups

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Jill Cole

Lead sponsor

University of Kentucky

Sponsor institution

Massage Therapy Foundation

Collaborator