[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07502157":3,"trial-entities:NCT07502157":112,"trial-summary:NCT07502157":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":44,"secondary_outcomes":61,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":15,"eligibility_criteria":76,"std_ages":83,"locations":86,"central_contacts":104,"overall_officials":107,"references":110,"see_also_links":111},"NCT07502157","107597","Massage, Oncology, Pain, Anxiety, Feasibility","The Impact of Massage Therapy on Pain and Anxiety of Patients With Gynecologic Cancer While Receiving Infusion Treatment (IMPACT)","RECRUITING","2026-12","2026-07","2026-08-03","2026-08","Jill Cole","OTHER",false,"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:\n\nCan 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\u002Fretention processes? Can investigators successfully collect outcome measures of pain and anxiety, pre\u002Fpost intervention? Researchers will investigate degree of resources needed, such as massage therapists, assessors, and timing of delivery intervention. Assess positive\u002Fnegative 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.\n\nEstablish variability in outcome measures.\n\nParticipants will:\n\nBe 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.",null,[19],"Gynecologic Cancer",[21,22,23,24,25],"Massage therapy","Pain","Anxiety","Cancer","Feasibility","INTERVENTIONAL","SUPPORTIVE_CARE",[29],"NA",{"count":31,"type":32},24,"ESTIMATED",[34,39],{"type":35,"name":36,"description":37,"armGroupLabels":38},"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.",[36],{"type":35,"name":40,"description":41,"armGroupLabels":42},"Attention Control","Massage therapist sits with gynecologic patient receiving an infusion asking questions for no more than 15 minutes.",[43],"Attention Control, No Massage Therapy",[45,49,52,55,58],{"measure":46,"description":47,"timeFrame":48},"Recruitment feasibility","Number of participants enrolled within the recruitment period.","6 months",{"measure":50,"description":51,"timeFrame":48},"Retention","Number of participants completing the study.",{"measure":53,"description":54,"timeFrame":48},"Randomization","Number of participants randomized",{"measure":56,"description":57,"timeFrame":48},"Percentage of accessors successful blinded","Assessors will be answering yes or no to the questionnaire and percentage will be calculated.",{"measure":59,"description":60,"timeFrame":48},"Number of participants that completed 3 or more sessions","Adherence is defined by participant completing 3 or more sessions.",[62,66,69],{"measure":63,"description":64,"timeFrame":65},"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.","Pre and post infusion therapy treatment (Up to 9 weeks)",{"measure":67,"description":68,"timeFrame":65},"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\u002Fpost 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.",{"measure":70,"description":71,"timeFrame":72},"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\u002Fpost 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.","Pre and Post infusion therapy treatment (Up to 9 weeks)","FEMALE","18 Years","85 Years",{"inclusion":77,"exclusion":80,"raw_text":82},[78,79],"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.",[81],"Patient with gynecologic cancer that has received infusion therapy anytime within the past 2 years.","Inclusion Criteria:\n\n* Patients with gynecologic cancer receiving active treatment of infusion, including but not limited to chemotherapy, immunotherapy, antibiotics, and blood.\n* Patients with gynecological cancer undergoing an infusion for the first time.\n\nExclusion Criteria:\n\n* Patient with gynecologic cancer that has received infusion therapy anytime within the past 2 years.",[84,85],"ADULT","OLDER_ADULT",[87],{"facility":88,"status":8,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":101},"University of Kentucky","Lexington","Kentucky","40506","United States",[94,99],{"name":95,"role":96,"phone":97,"email":98},"Jill S Cole, MA, LMT, BCTMB","CONTACT","859-323-7087","jill.cole1@uky.edu",{"name":95,"role":100},"PRINCIPAL_INVESTIGATOR",{"lat":102,"lon":103},37.98869,-84.47772,[105],{"name":106,"role":96,"phone":97,"email":98},"Jill S Cole, MA, LMT, BCMTB",[108],{"name":95,"affiliation":109,"role":100},"University of Kentucky, Integrative Medicine and Health",[],[],{"nct_id":4,"conditions":113,"biomarkers":115},[114],"Malignant Female Reproductive System Neoplasm",[],{"nct_id":4,"found":117,"summary":118,"prompt_version":128},true,{"design":119,"status":120,"heading":121,"summary":122,"follow_up":123,"word_count":124,"commitments":125,"compensation":126,"drugs_mentioned":127},"This study is an interventional study with an unclear phase, planning to enroll 24 participants. It will compare massage therapy to an attention control group where a therapist sits and talks with you.","completed","Massage Therapy for Pain and Anxiety in Gynecologic Cancer Patients","This study is looking at whether it's practical to offer massage therapy to women with gynecologic cancer while they are receiving infusion treatments (like chemotherapy or immunotherapy). Researchers want to see if they can successfully recruit and keep participants, and if they can measure changes in pain and anxiety before and after massage. You would be eligible if you are a woman between 18 and 85 years old with gynecologic cancer, receiving your first infusion treatment. The study is trying to enroll 24 participants. The main goal is to understand if this type of study can be done effectively, not to prove if massage works yet.","The study will assess how well it's recruiting and retaining participants for 6 months.",106,"If you join, you will receive either a 15-20 minute massage (hand, foot, or neck\u002Fshoulder) or have a massage therapist sit and talk with you for up to 15 minutes during your infusion.","Not stated in the trial record.",[36],"v2"]