Health TrialsbyHealthPanel

Massage, Oncology, Pain, Anxiety, Feasibility

ConditionGynecologic Cancer
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Massage Therapy

    Procedure/Surgery

    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/Surgery

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

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Attention Control, No Massage TherapyPlacebo comparator 1 intervention
Group B: Massage TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment feasibility

Number of participants enrolled within the recruitment period.

Time frame
6 months
2

Retention

Number of participants completing the study.

Time frame
6 months
3

Randomization

Number of participants randomized

Time frame
6 months
4

Percentage of accessors successful blinded

Assessors will be answering yes or no to the questionnaire and percentage will be calculated.

Time frame
6 months

Secondary outcomes

1

Change in Defense and Veterans Pain Rating Scale (DVPRS)

DVPRS ranges from 0-10. 0 being no pain and 10 being worst pain of patient's life.

Time frame
Pre and post infusion therapy treatment (Up to 9 weeks)
2

Change in State-Trait Anxiety Inventory (STAI)

The STAI-6 will be used to measure and collect a self-reported anxiety score from the study participant pre/post intervention. The questions asked are, "I feel calm; I am tense; I feel upset; I am relaxed; I feel content; I am worried." The answers are on a scale of 1-4, with 1=Almost never, 2=Somewhat, 3=Moderately, 4=Very much.

Time frame
Pre and post infusion therapy treatment (Up to 9 weeks)
3

Temporal Summation, Pain Threshold using von Frey Monofilaments

Using a 180 gram von Frey filament, threshold for pain will be used by performing temporal summation wind-up method. The wind-up method will be used to measure pain pre/post intervention, of each study participant, during all three intervention sessions. Each assessor will use the thenar eminence (thumb pad) of the participate, applying pressure straight down, until a "C" with the filament is formed. After the "C" is formed on the participant, the assessor will ask, on a scale of 0-10 (zero being no pain and 10 being the worst pain imaginable) what their perceived rate of pain intensity was. The assessor will then use a stopwatch on their phone to wait 30 seconds and then apply the same filament on the same thenar eminence 10 times in the same area, at a rate of 60hz or 1 per second (still making a "C"). The assessor will then ask, on a scale of 0-10, (zero being no pain and 10 being the worst pain imaginable) what their perceived rate of pain intensity.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jill Cole

Lead sponsor

University of Kentucky

Sponsor institution

Massage Therapy Foundation

Collaborator

Source ClinicalTrials.gov
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