Fisioterapia pélvica para la disfunción sexual en sobrevivientes de oncología ginecológica
Viabilidad de la fisioterapia pélvica para la disfunción sexual en sobrevivientes de oncología ginecológica
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27157
- Wake Forest Baptist Comprehensive Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Control Arm
Educational pamphlet with resources for sexual dysfunction |
Participants randomized to this arm will only receive educational pamphlets with resources for sexual dysfunction and will not participate in physical therapy. Participants will be contacted at 3 months and 6 months to fill out two questionnaires about sexual function and quality of life. After 6months, if participants desire a referral to physical therapy, investigators will provide a referral. |
|
Experimental: Physical Therapy Arm
Physical therapy for sexual dysfunction. |
Participants will receive a referral to begin a pelvic physical therapy regimen. Participants will complete the sexual function and quality of life questionnaires after completion of the physical therapy regimen and again 3 months after. There will be a brief exit interview. Questionnaire designed to measure cancer patients' physical, psychological and social functions 19-item self-report inventory designed to assess female sexual function. 11-item questionnaire for participants to give feedback to investigators about teir experience with the intervention. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Accrual to Study Intervention
Periodo de tiempo: At baseline
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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. |
At baseline
|
|
Number of Participants Retained to Study Intervention
Periodo de tiempo: 3 months after completion of physical therapy.
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Retention is participants' attendance of pelvic physical therapy visits. |
3 months after completion of physical therapy.
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Adherence to Study Intervention
Periodo de tiempo: 3 months after completion of physical therapy.
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Adherence is the number of enrolled participants completing the full series of questionnaires. |
3 months after completion of physical therapy.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Female Sexual Function Index (FSFI) Questionnaire
Periodo de tiempo: (T0) at time of randomization, (T1) after completion of the 10-week PPT regimen - 3 months after randomization, and (T2) 3 months after T1.
|
The questionnaire is comprised of six domains: desire [two items], arousal [four items], lubrication [four items], orgasm, satisfaction, pain [three items each]. Score range is 1 to 5. The FSFI total score is the sum of the 6 domain/subscale scores and has a maximum score of 36. Higher scores indicate better functioning. |
(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
Periodo de tiempo: (T0) at time of randomization, (T1) after completion of the 10-week PPT regimen - 3 months after randomization, and (T2) 3 months after T1.
|
The EORTC QLQ-C30 questionnaire will be completed three times during study intervention and is patient reported to assess sexual function and health-related quality of life. Score range is 0 to 100. A high score for a functional scale represents a high/ healthy level of functioning; a high score for the global health status /quality of life represents a high quality of life; a high score for a symptom scale/item represents a high level of symptomatology / problems. |
(T0) at time of randomization, (T1) after completion of the 10-week PPT regimen - 3 months after randomization, and (T2) 3 months after T1.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Anya Menzies, PhD, Wake Forest Baptist Comprehensive Cancer Center
- Investigador principal: Suzanne K Danhauer, PhD, Wake Forest Baptist Comprehensive Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00079802
- P30CA012197 (Subvención/contrato del NIH de EE. UU.)
- WFBCCC 01421 (Otro identificador: Wake Forest Baptist Comprehensive Cancer Center)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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