Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer
24 de octubre de 2018 actualizado por: Fox Chase Cancer Center
The central goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of the IE intervention on patient and partner sexual QOL and relationship outcomes, and on patient psychosocial outcomes.
We expect that the IE will show adequate feasibility, acceptability, and preliminary efficacy.
Secondarily, based on the rationale that barriers exist that limit participation in intensive sexual QOL interventions for breast cancer survivors, an innovative secondary aim will investigate the perspectives of study-eligible patient candidates who opt out of participating in the pilot trial.
We expect that we will be able to identify the participation barriers and intervention preferences of breast cancer survivors with sexual concerns who opt out of the intensive trial in order to inform the development of different interventions for future study.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
89
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- Fox Chase Cancer Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
21 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Female
- Age > 21 years
- Has diagnosis of non-recurrent stage I-III breast cancer
- Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable)
- Has a partner or spouse who is > 21
- Lives with a romantic partner > 6 months
- Score of > 3 on Patient Care Monitor Sexual Concerns screening item
- No hearing impairment in patient or partner
Exclusion Criteria:
- Not able to speak English, as stated in medical record or as observed by study team member
- ECOG Performance score > 2 OR too ill to participate as judged by physician/in medical record
- Overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, referring source, or other qualified observer.
- Past history of any cancer other than non-melanoma skin cancer
- Currently participating in couple/marital therapy
- Currently pregnant
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
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Experimental: Intimacy Enhancing Intervention
Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks.
The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges.
Participants are encouraged to participate in written and behavioral activities at home.
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Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks.
The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges.
Participants are encouraged to participate in written and behavioral activities at home.
Receive couple-based intimacy enhancement intervention
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Comparador activo: Living Healthy Together
Participants receive educational information and support about breast cancer every other week for 4 weeks.
The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet.
Participants are encouraged to read educational materials.
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Participants receive educational information and support about breast cancer every other week for 4 weeks.
The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet.
Participants are encouraged to read educational materials.
Receive educational information and support
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of the Treatment as Measured Through Study Accrual
Periodo de tiempo: Up to 8 weeks
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Feasibility is measured through the percentage of study eligible individuals who enrolled in the intervention study (i.e., acceptance rate).
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Up to 8 weeks
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Feasibility of the Treatment as Measured Through Study Attrition
Periodo de tiempo: Up to 8 weeks
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Feasibility of treatment is measured through the number of randomized participants who completed the study.
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Up to 8 weeks
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Feasibility of the Treatment as Measured Through Session Completion by Participant
Periodo de tiempo: Up to 8 weeks
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Feasibility of the treatment as measured through number of randomized participants who completed all 4 telephone sessions.
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Up to 8 weeks
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Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8)
Periodo de tiempo: Up to 8 weeks
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Acceptability was measured through the median score on a validated acceptability measure.
Item responses run on a scale of 1 to 4, with a total score range of 8-32.
Higher scores indicate higher satisfaction with the service (acceptability).
A median score of 28 or higher is considered acceptable.
This measure was collected for both patients and partners.
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Up to 8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI)
Periodo de tiempo: Baseline to up to 8 weeks
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Total scale scores range from 2 to 36.
Higher scores indicate higher level of functioning.
Change in mean patient FSFI score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in sexual functioning from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Sexual Function Measured Using the International Index of Erectile Function
Periodo de tiempo: Baseline to up to 8 weeks
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Total scale scores range from 1 to 75, with higher scores indicating a higher level of sexual functioning.
Change in mean male partner IIEF score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in sexual functioning from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Sexual Satisfaction Measured Using the Patient-Reported-Outcomes Measurement Information System (PROMIS) Sexual Satisfaction Items
Periodo de tiempo: Baseline to up to 8 weeks
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The PROMIS uses T-scores that are calculated against U.S. population norms with a M of 50 and SD of 10.
Higher T-scores indicate higher levels of sexual satisfaction.
Change in sexual satisfaction T-scores from pre-intervention to post-intervention are reported.
Positive change scores indicate increase in sexual satisfaction from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Sexual Distress Measured Using the Female Sexual Distress Scale-Revised
Periodo de tiempo: Baseline to up to 8 weeks
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Total scale scores range from 0 to 52.
Higher scores indicate higher levels of sexual distress.
Change in patient mean sexual distress score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in sexual distress from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Beliefs (Self-efficacy)
Periodo de tiempo: Baseline to up to 8 weeks
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Total scale scores range from 0 to 100.
Higher scores indicate higher degree of self-efficacy for coping with sexual concerns.
Change in mean self-efficacy score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in self-efficacy from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Emotional Intimacy Measured Using the Personal Assessment of Intimacy in Relationships (PAIR) Emotional Intimacy Scale
Periodo de tiempo: Baseline to up to 8 weeks
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Total scale scores range from 1 to 5. Higher scores indicate higher level of emotional intimacy with one's partner.
Change in mean emotional intimacy score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in emotional intimacy from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Sexual Communication Measured Using the Dyadic Sexual Communication Scale
Periodo de tiempo: Baseline to up to 8 weeks
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Total scale scores range from 13 to 78.
Higher scores indicate more communication.
Change in mean sexual communication score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in sexual communication from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Relationship Quality Measured Using the Dyadic Adjustment Scale-7 Item
Periodo de tiempo: Baseline to up to 8 weeks
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Total scale scores range from 0 to 36.
Higher scores indicate higher relationship quality.
Change in mean relationship quality score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in relationship quality from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Body Image Distress Measured Using the Body Image Scale
Periodo de tiempo: Baseline to up to 8 weeks
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Total scale scores range from 0 to 30.
Higher scores indicate higher level of body image distress.
Change in mean body image distress score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in body image distress from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Depression Measured Using the Patient Health Questionnaire-9 Item
Periodo de tiempo: Baseline to up to 8 weeks
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Total scale scores range from 0 to 27.
Higher scores indicate higher level of depression.
Change in mean depression score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in depression from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Anxiety Measured Using the Generalized Anxiety Disorder 7-item
Periodo de tiempo: Baseline to up to 8 weeks
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Total scale scores range from 0 to 21.
Higher scores indicate higher levels of anxiety.
Change in mean anxiety score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in anxiety from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Cancer-related Distress Using the Impact of Events Scale-Revised
Periodo de tiempo: Baseline to up to 8 weeks
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Total scale scores range from 0 to 88.
Higher scores indicate higher levels of distress.
Change in mean cancer-related distress score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in distress from pre- to post-intervention.
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Baseline to up to 8 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
27 de octubre de 2015
Finalización primaria (Actual)
29 de septiembre de 2017
Finalización del estudio (Actual)
29 de septiembre de 2017
Fechas de registro del estudio
Enviado por primera vez
14 de marzo de 2016
Primero enviado que cumplió con los criterios de control de calidad
28 de marzo de 2016
Publicado por primera vez (Estimar)
29 de marzo de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de octubre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
24 de octubre de 2018
Última verificación
1 de octubre de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 15-8007
- 1R21CA191354-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
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INDECISO
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