Feasibility of Pelvic Physical Therapy for Sexual Dysfunction in Gynecologic Oncology Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants Retained to Study Intervention
研究概览
简要总结
The purpose of this research study is to investigate the use of pelvic physical therapy for gynecologic cancer survivors who report sexual dysfunction. Physical therapy experts believe that a full 10-week regimen is necessary for true improvement of symptoms. Investigators aim to see if this tense regimen is feasible for survivors. Investigators also aim to see if patients have an improvement in their sexual function and quality of life.
详细描述
Primary Objective(s): To determine the feasibility of an intensive pelvic physical therapy intervention with gynecologic cancer survivors reporting sexual dysfunction. Feasibility will be determined by accrual, retention, and adherence.
Secondary Objective(s):
- To demonstrate preliminary efficacy of the pelvic physical therapy intervention on sexual function in gynecologic cancer survivors. Sexual function will be measured three times: at time of randomization (T0), after completion of the 10-week pelvic physical therapy regimen - 3 months after randomization (T1), and 3 months after T1 (T2).
- To demonstrate preliminary efficacy of the pelvic physical therapy intervention on health-related quality of life in gynecologic cancer survivors. Quality of life will be measured at three times (T0) at time of randomization, (T1) after completion of the 10-week pelvic physical therapy regimen - 3 months after randomization, and (T2) 3 months after T1
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of cervical, ovarian/fallopian tube/primary peritoneal, uterine, or vulvar/vaginal cancer, regardless of stage or amount of prior therapy. Patients must have completed radiation therapy 12 weeks prior enrollment. Patients must be at least 12 weeks remote from surgery. There is no minimum time after completion of chemotherapy for enrollment. There is no upper limit of time from treatment.
- •History of treatment for gynecological cancer - surgery, radiation, chemotherapy, or combination of therapies.
- •Screen positive for sexual dysfunction based on answers to the Brief Sexual Symptom Checklist for Women. A patient screens positive if they answer "no" to the first question (Are you satisfied with your sexual function?) and if they select any answer other than "a" in the third question (Mark which of the following problems you are having). The other questions do not impact whether a patient screens positive or negative. They do not have an impact on study eligibility.
- •English-speaking. Due to the developmental nature of this study, assessing feasibility with a small number of patients, we do not have all response tools and questionnaires translated into multiple languages. In a future larger study, it will be important to translate all documents into multiple languages in order to include non-English speakers.
- •Age ≥18 years
排除标准
- •Active pelvic infection
- •Presence of vaginal fistula
- •Deemed not suitable for PPT based on physician assessment. If there is suspicion for infection, disease recurrence, or other concerning medical findings that necessitate further evaluation and work up at that time.
- •Evidence of active cancer
结局指标
主要结局
Number of Participants Retained to Study Intervention
时间窗: 3 months after completion of physical therapy.
Retention is participants' attendance of pelvic physical therapy visits.
Accrual to Study Intervention
时间窗: At baseline
Accrual is the number of participants that screen positive for sexual dysfunction, are eligible for entry into the study and consent to participate in the study.
Adherence to Study Intervention
时间窗: 3 months after completion of physical therapy.
Adherence is the number of enrolled participants completing the full series of questionnaires.
次要结局
- Female Sexual Function Index (FSFI) Questionnaire((T0) at time of randomization, (T1) after completion of the 10-week PPT regimen - 3 months after randomization, and (T2) 3 months after T1.)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire((T0) at time of randomization, (T1) after completion of the 10-week PPT regimen - 3 months after randomization, and (T2) 3 months after T1.)