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An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners (OPIC)

9 de abril de 2013 atualizado por: Karen Fergus, Sunnybrook Health Sciences Centre
Breast cancer is distressing for couples in general but even more so when the illness strikes at a relatively young age. In addition to common relationship challenges, younger couples have to contend with the loss or disruption of age-appropriate goals for themselves. Presently, there are virtually no resources designed specifically to assist young couples coping with breast cancer. The purpose of this study is to develop and evaluate an online educational program geared to the unique needs and demanding schedules of young couples. The purpose of the program is to improve couples' relationships and mutual coping. Seventeen couples will take part in the 7-week program. They will complete questionnaires before and after participating to evaluate the program's helpfulness. This study will allow for the creation of a user-friendly, cost-effective tool that could help to improve the lives of all young couples coping with breast cancer in the years to come.

Visão geral do estudo

Status

Concluído

Condições

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

Intervencional

Inscrição (Real)

20

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

    • Ontario
      • Toronto, Ontario, Canadá, M4N 3M5
        • Sunnybrook Odette Cancer Centre

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

20 anos a 45 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

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

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: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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

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

1 de setembro de 2008

Conclusão Primária (Real)

1 de julho de 2011

Conclusão do estudo (Real)

1 de julho de 2011

Datas de inscrição no estudo

Enviado pela primeira vez

15 de outubro de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de abril de 2011

Primeira postagem (Estimativa)

27 de abril de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

10 de abril de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de abril de 2013

Última verificação

1 de abril de 2011

Mais Informações

Termos relacionados a este estudo

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

Ensaios clínicos em Psychosocial Intervention for Couples

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