Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer
24 de outubro de 2018 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
89
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- Fox Chase Cancer Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
21 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Feasibility of the Treatment as Measured Through Study Accrual
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
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Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
27 de outubro de 2015
Conclusão Primária (Real)
29 de setembro de 2017
Conclusão do estudo (Real)
29 de setembro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
14 de março de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de março de 2016
Primeira postagem (Estimativa)
29 de março de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de outubro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de outubro de 2018
Última verificação
1 de outubro de 2018
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 15-8007
- 1R21CA191354-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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