Gynecologic Cancer
Conditions
Keywords
Massage therapy, Pain, Anxiety, Cancer, Feasibility
Brief 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.
Interventions
PROCEDUREMassage 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.
PROCEDUREAttention Control
Massage therapist sits with gynecologic patient receiving an infusion asking questions for no more than 15 minutes.
Sponsors
Jill Cole
Massage Therapy Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment feasibility | 6 months | Number of participants enrolled within the recruitment period. |
| Retention | 6 months | Number of participants completing the study. |
| Randomization | 6 months | Number of participants randomized |
| Percentage of accessors successful blinded | 6 months | Assessors will be answering yes or no to the questionnaire and percentage will be calculated. |
| Number of participants that completed 3 or more sessions | 6 months | Adherence is defined by participant completing 3 or more sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Defense and Veterans Pain Rating Scale (DVPRS) | Pre and post infusion therapy treatment (Up to 9 weeks) | DVPRS ranges from 0-10. 0 being no pain and 10 being worst pain of patient's life. |
| Change in State-Trait Anxiety Inventory (STAI) | Pre and post infusion therapy treatment (Up to 9 weeks) | 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. |
| Temporal Summation, Pain Threshold using von Frey Monofilaments | Pre and Post infusion therapy treatment (Up to 9 weeks) | 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. |
Countries
United States
Contacts
CONTACTJill S Cole, MA, LMT, BCMTB
PRINCIPAL_INVESTIGATORJill S Cole, MA, LMT, BCTMB
University of Kentucky, Integrative Medicine and Health
Outcome results
None listed