- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01342302
An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners (OPIC)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Women diagnosed with breast cancer at or before the age of 40 experience greater distress and poorer quality of life than women diagnosed later in life. In addition to having to cope with the range of issues common to all women with breast cancer, young women face unique challenges such as loss of fertility, concerns for young children, and interruptions to early-stage careers. The presence of adequate social support is a mitigating factor for distress in young women, and spousal support in particular has been shown to play a crucial and distinctive role in determining how well a woman adjusts to breast cancer. Unfortunately, the evidence suggests well-spouses are significantly distressed themselves, and often fall short in their attempts to meet the needs of their ill partners despite generally good intentions. Consequently, researchers have recommended that psychosocial interventions be geared to couples. However, traditional counseling interventions may not appeal to younger couples with numerous responsibilities and time constraints.
The purpose of this study is to examine the feasibility, process, and outcomes of an innovative online intervention tailored to the unique needs of young women and their partners. The primary goal is to improve partners' relationship functioning and capacity to work together as a team in relation to the illness. The secondary goal is to combat feelings of isolation by creating a community of similarly affected couples. The intervention will be delivered via a professionally moderated, password-protected website and entail: Information relevant to young couples with breast cancer; structured, interactive learning modules; and a discussion board. The online modality is particularly suited to the younger demographic targeted by this project because of its familiarity, comfort, convenience, and flexibility.
A non-randomized, repeated measures analysis of variance design will be used to test the intervention. Seventeen couples will be recruited within the Greater Toronto Area. Questionnaires assessing relationship functioning, psychological adjustment, and quality of life will be administered to participants at baseline and at completion of the 7-week program. Qualitative data from the website and treatment satisfaction questionnaire will be analyzed thematically in order to improve the intervention and its delivery.
The potential for this online intervention to fill a void in support options available to both young women with breast cancer and their partners is vast. Following completion of the project, not only will there be a demonstrable product in the website, but the investigators will have the knowledge with which to further test the intervention in a RCT. The ultimate impact of the proposed project will be the creation of an accessible, cost-effective, empirically validated tool that could help to improve the quality of life of all young couples coping with breast cancer, regardless of geographic location, in the years to come.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Ontario
-
Toronto, Ontario, Canadá, M4N 3M5
- Sunnybrook Odette Cancer Centre
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- woman has received a diagnosis of breast carcinoma within the last 18 months at any point in her treatment trajectory.
- Women must be free of known local recurrence or metastatic disease at the time of enrolment.
- Patients will have been 40 years of age or younger when diagnosed.
- Partners must be 45 years of age or younger at the time of diagnosis. - Couples must be heterosexual, and married, cohabitating, or engaged. - Participants must be fluent in English with the ability to read and write in English.
- All participants will require convenient access to a computer with internet connection.
Exclusion Criteria:
- All participants will be screened for mental illness that would interfere with their capacity to benefit from the program (e.g., suicidality, psychotic disorders, substance abuse) and excluded on this basis.
- Couples who plan to participate in couple or individual counselling during the 7-week study duration will be excluded.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Outro: Couples Intervention
Single arm study design
|
Intervention delivered on line
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in Dyadic Adjustment Scale (DAS) scores from pre (0 weeks) to post-treatment (7 weeks)
Prazo: pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
|
The DAS assesses couple's level of relationship satisfaction.
The DAS will be used to assess change in couples' level of relationship satisfaction following participation in the Couplelinks program over a 7 week period, from pre-treatment (0 weeks) to post-treatment (7 weeks).
|
pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
|
Change in Personal Assessment of Intimacy in Relationships scale scores from pre (0 weeks) to post-treatment (7 weeks)
Prazo: pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
|
The Personal Assessment of Intimacy in Relationships scale assesses the degree of feelings of intimacy between partners.
This primary outcome measure will be used to assess changes in the degree of the feelings of intimacy between partners following participation in the Couplelinks program over a 7 week period, from pre-treatment (0 weeks) to post-treatment (7 weeks).
|
pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Mental Psychological Development Questionnaire (MPDQ)
Prazo: Pre-treatment (0 weeks) and immediate post-treatment (12 weeks).
|
The MPDQ assesses individual psychological adjustment.
|
Pre-treatment (0 weeks) and immediate post-treatment (12 weeks).
|
Mental Health Inventory (MHI)
Prazo: pre-treatment (0 weeks) and post-treatment (7 weeks)
|
The MHI assesses individual psychological adjustment.
|
pre-treatment (0 weeks) and post-treatment (7 weeks)
|
Hospital Anxiety and Depression Scale (HADS)
Prazo: pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
|
The HADS assesses individual psychological adjustment.
|
pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
|
Functional Assessment of Cancer Therapy-Breast (FACT-B)
Prazo: pre-treatment (0 weeks) and immediate post-treatment (7 weeks
|
The FACT-B assesses women's individual physical and psychological adjustment to breast cancer treatment.
|
pre-treatment (0 weeks) and immediate post-treatment (7 weeks
|
Breast Cancer and Relationship Measure
Prazo: pre-treatment (0 weeks) and immediate post-treatment (7 weeks
|
This measure assesses the impact of breast cancer on couple mutuality.
|
pre-treatment (0 weeks) and immediate post-treatment (7 weeks
|
Treatment Expectancy and Motivation Measure (TEMM)
Prazo: pre-treatment (0 weeks)
|
The TEMM assesses the degree to which individuals believe that the treatment will be helpful to them prior to starting the treatment.
|
pre-treatment (0 weeks)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Karen Fergus, PhD, Toronto Sunnybrook Regional Cancer Centre
- Diretor de estudo: Debbie McLeod, PhD, RN, Cancer Care Program, Nova Scotia Cancer Centre
- Diretor de estudo: Ellen Warner, MD, Toronto Sunnybrook Regional Cancer Centre
- Diretor de estudo: Sandra Gardner, PhD, Toronto Sunnybrook Regional Cancer Centre
- Diretor de estudo: Margaret Fitch, RN, Toronto Sunnybrook Regional Cancer Centre
- Diretor de estudo: Barbara Fitzgerald, RN, Princess Margaret Hospital, Canada
- Diretor de estudo: Leeat Granek, PhD, Toronto Sunnybrook Regional Cancer Centre
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 200-2008
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Câncer de mama
-
Turku University HospitalLounais-Suomen SyöpäyhdistysAinda não está recrutandoSobrevivente de cancerFinlândia
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RetiradoSobrevivente de cancerEstados Unidos
-
University of Alabama at BirminghamNational Cancer Institute (NCI); Auburn UniversityConcluído
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos, Guam
-
Wake Forest University Health SciencesNational Cancer Institute (NCI); National Institute of Mental Health (NIMH)ConcluídoSobrevivente de cancerEstados Unidos
-
Masonic Cancer Center, University of MinnesotaConcluídoSobrevivente de cancerEstados Unidos
-
Abramson Cancer Center of the University of PennsylvaniaConcluídoPlano de cuidados de sobrevivência LIVESTRONG: coleta contínua de dados e pesquisa de acompanhamentoPaciente com cancerEstados Unidos
-
University of New MexicoNew Mexico State University; University of New Mexico Cancer CenterConcluído
-
Ohio State University Comprehensive Cancer CenterConcluídoSobrevivente de cancerEstados Unidos
Ensaios clínicos em Psychosocial Intervention for Couples
-
University of TurkuDesconhecidoSaudável | Comportamento de saúdeFinlândia
-
Henry Ford Health SystemBlue Cross Blue Shield of Michigan FoundationConcluído
-
Munich Municipal HospitalTechnical University of Munich; University of RegensburgDesconhecidoInfarto CerebralAlemanha
-
Northwestern UniversityEmory UniversityConcluídoAfasia Progressiva Primária | Esgotamento do cuidadorEstados Unidos
-
Rhode Island HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...ConcluídoCyberbullyingEstados Unidos
-
University of VirginiaConcluídoLesão da medula espinal | Úlceras de pressãoEstados Unidos
-
Charles G. ProberStanford University; Heidelberg University; University of Stellenbosch; University...ConcluídoAleitamento Materno Exclusivo | Práticas de alimentação infantilÁfrica do Sul
-
University of Alabama, TuscaloosaNational Institute of Nursing Research (NINR)ConcluídoDor | Cuidado paliativo | Distúrbios da Retenção Cognitiva | Outra doença crônicaEstados Unidos
-
Brigham and Women's HospitalUniversity of Colorado, DenverConcluídoDiabetes Mellitus GestacionalEstados Unidos
-
LuciLabCentre de Recherche de l'Institut Universitaire de Geriatrie de Montreal; Sojecci...ConcluídoComportamento de risco | Declínio CognitivoCanadá