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Psychological Services Integration in Gynecological Oncology Clinics

30 de maio de 2019 atualizado por: Washington University School of Medicine

Implementation and Evaluation of Psychological Services Integration in Gynecological Oncology Clinics

The purpose of this study is to understand the feasibility and impact of integrated psychological care in outpatient gynecologic oncology clinics with the goal of creating a new standard of care. The investigators propose an intervention study comparing patient-centered outcomes (assessed by surveys) between women who receive usual care versus integrated psychological care. The investigators' objectives are to learn about the process of integration of psychological care directly into outpatient gynecologic oncology clinics and the impact of such integration on patients' well-being, presentation of symptoms, psychological functioning, coping mechanisms, awareness of support services offered, and perception of quality of care. As this is a feasibility study, aims are focused on assessing patient willingness for psychological intervention in the medical office, provider willingness to have psychologist present in clinic, and impact of psychological intervention. With such data to warrant further integration and time of psychologists in medical clinics, next steps for immediate and long-term projects may include focus on high risk populations, specific disease sites, additional provider clinics, more psychologist time spent in gynecological oncology clinics, and effectiveness of interventions with higher power. The investigators hope the results will serve as preliminary data for an integrated psychosocial care model that can be implemented in other oncology clinics.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

101

Estágio

  • Fase 1

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

  • Estados Unidos
    • Missouri
      • Saint Louis, Missouri, Estados Unidos, 63110
        • Washington University School of Medicine

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Aged 18 years or older
  • Scheduled for an appointment in a gynecologic oncology clinic at the Siteman Cancer Center at the Center for Advanced Medicine or the Women's Tumor Clinic at the Center for Outpatient Health at Barnes-Jewish Hospital
  • Patients may or may not have a cancer diagnosis.
  • All gynecologic cancer types, histologic grades, primary or recurrent disease.
  • Patients actively undergoing treatment or close observation
  • Pregnant or lactating patients
  • Able to speak and read English
  • Able to consent

Inclusion criteria (correlative studies only) -Patients who are undergoing pre-operative work-up for evaluation of an adnexal mass by a Washington University gynecologic oncologist.

Exclusion Criteria:

-Impaired by a psychiatric or cognitive disorder that limits their ability to give consent or communicate with their medical providers about symptoms (as determined by the patient's medical team)

Exclusion criteria (correlative studies only)

  • Neoadjuvant chemotherapy
  • Treatment within the past month with antidepressant medications that affect serotonin physiology
  • Specific histology: low malignant potential tumors, non-epithelial cancer histology.
  • Previous cancer diagnosis within the past five years or recurrent cancer
  • Regular steroid use in the last month
  • Presence of comorbidities with known effects on the immune system (e.g., systemic lupus erythematosus, multiple sclerosis, and rheumatoid arthritis), congestive heart failure, pregnancy, or stroke within the past six months
  • Major surgery in the past month.

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: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Arm 1: Usual Care
-No psychosocial care in clinic
Outro: Surveys
  • NCCN Distress Thermometer
  • PROMIS Depression & Anxiety
  • Quality of Life (SF-12)
  • Brief COPE
  • Patient awareness and satisfaction survey
Procedimento: Blood draw
  • For patients with ovarian, fallopian tube, or primary peritoneal cysts
  • Optional
  • Enrollment, 3 months after enrollment, and 6 months after enrollment
Procedimento: Fresh tissue from ovary
  • For patients with ovarian, fallopian tube, or primary peritoneal cysts
  • Optional
  • At time of standard of care surgery
Experimental: Arm 2: Integrated Care
-Those who receive integrated care will receive a one-page care plan completed by Dr. Vanderlan including their scores from screening questionnaires , recommendations for coping strategies and available supportive resources.
Outro: Surveys
  • NCCN Distress Thermometer
  • PROMIS Depression & Anxiety
  • Quality of Life (SF-12)
  • Brief COPE
  • Patient awareness and satisfaction survey
Procedimento: Blood draw
  • For patients with ovarian, fallopian tube, or primary peritoneal cysts
  • Optional
  • Enrollment, 3 months after enrollment, and 6 months after enrollment
Procedimento: Fresh tissue from ovary
  • For patients with ovarian, fallopian tube, or primary peritoneal cysts
  • Optional
  • At time of standard of care surgery
Comportamental: Integrated psychological care
Additional possible strategies used may include supportive or validating interventions, increasing/introducing/reinforcing coping strategies, psychoeducation; distress tolerance skills; brief cognitive behavioral therapy; cognitive restructuring; activity scheduling; acceptance; and relaxation/mindfulness.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Feasibility of integrating psychosocial care by a trained psychologist into gynecologic cancer outpatient clinics as measured by patient enrollment
Prazo: Completion of patient enrollment (approximately 12 months)
-Willingness to participate with integrated care as quantified by proportion of enrolled patients from the number of approached eligible patients
Completion of patient enrollment (approximately 12 months)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Provider willingness to have a psychologist present
Prazo: 6 months after start of study enrollment
-5 item survey about willingness to have psychologist present in clinic
6 months after start of study enrollment
Differences in clinic visit duration with and without a psychologist present
Prazo: Day 1
-Clinic visit duration is defined as the time from check-in to patient discharge
Day 1
Difference in psychological correlates of daily functioning as measured by patient distress between women who receive usual care versus integrated psychological care
Prazo: Enrollment, 3 months after enrollment, and 6 months after enrollment
  • NCCN Distress Thermometer: picture of thermometer that states to circle the number that best describes how much distress has been experienced in the past week (10=extreme distress and 0=no distress)
  • Next section contains categories of Practical Problems, Family Problems, Emotional Problems, Physical Problems, Spiritual/religious concerns - participant is to mark yes or no to indicate if they have had problems in the past week
  • The distress thermometer score of 0-10 is recorded. The problem areas endorsements are tallied within each problem area.
Enrollment, 3 months after enrollment, and 6 months after enrollment
Difference in psychological correlates of daily functioning as measured by patient depression between women who receive usual care versus integrated psychological care
Prazo: Enrollment, 3 months after enrollment, and 6 months after enrollment
  • PROMIS Depression & Anxiety - asks participant in the last 7 days if they have felt worthless, helpless, depressed, hopeless, fearful, lack of focus, worrying, and uneasy. Check box choices are never, rarely, sometimes, often, and always
  • Each question has five response options ranging in value from one to five. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. Never = 1, rarely = 2, sometimes = 3, often =4, always = 5. Points are added to raw score. Raw score is converted to t-score via short form conversion table.
Enrollment, 3 months after enrollment, and 6 months after enrollment
Difference in psychological correlates of daily functioning as measured by patient anxiety between women who receive usual care versus integrated psychological care
Prazo: Enrollment, 3 months after enrollment, and 6 months after enrollment
  • PROMIS Depression & Anxiety - asks participant in the last 7 days if they have felt worthless, helpless, depressed, hopeless, fearful, lack of focus, worrying, and uneasy. Check box choices are never, rarely, sometimes, often, and always
  • Point values are as follows: never =1, rarely, rarely = 2, sometimes = 3, often =4, always = 5. Points are added to raw score. Raw score is converted to t-score via short form conversion table.
Enrollment, 3 months after enrollment, and 6 months after enrollment
Difference in psychological correlates of daily functioning as measured by patient quality of life between women who receive usual care versus integrated psychological care
Prazo: Enrollment, 3 months after enrollment, and 6 months after enrollment
  • Quality of life (SF-12): 12 item survey
  • Scores are recoded to give numerical value, with some items reverse scored. Scoring is broken down into mental health and physical health subscale scores.
Enrollment, 3 months after enrollment, and 6 months after enrollment
Difference in psychological correlates of daily functioning as measured by patient coping mechanisms between women who receive usual care versus integrated psychological care
Prazo: Enrollment, 3 months after enrollment, and 6 months after enrollment
  • Brief COPE: 28 item survey with answers ranging from 1=I haven't been doing this at all to 4=I've been doing this a lot
  • Scores are on tallied based on answers to 4 point likert scale. No reverse scoring. There are 14 subscales with two questions each.
Enrollment, 3 months after enrollment, and 6 months after enrollment
Difference in psychological correlates of perception of psychological care as measured by patient perception of Siteman Cancer Center being highly focused on their wellbeing between women who receive usual care versus integrated psychological care
Prazo: Enrollment, 3 months after enrollment, and 6 months after enrollment
  • 4 item survey
  • Each question has five response options ranging in value from one to five. To find the total raw score for a short form with all questions answered, sum the values of the response to each question.
  • 1=strongly disagree to 5=strongly agree
Enrollment, 3 months after enrollment, and 6 months after enrollment
Difference in psychological correlates of awareness of psychological care as measured by awareness of support services offered between women who receive usual care versus integrated psychological care
Prazo: Enrollment, 3 months after enrollment, and 6 months after enrollment
  • 4 item survey

  • Each question has five response options ranging in value from one to five. To find the total raw score for a short form with all questions answered, sum the values of the response to each question.

    • 1=strongly disagree to 5=strongly agree
Enrollment, 3 months after enrollment, and 6 months after enrollment

Colaboradores e Investigadores

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

Patrocinador

Washington University School of Medicine

Colaboradores

Barnes-Jewish Hospital

Investigadores

  • Investigador principal: Jessica Vanderlan, Ph.D., Washington University School of Medicine

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

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)

8 de maio de 2018

Conclusão Primária (Real)

29 de agosto de 2018

Conclusão do estudo (Real)

26 de março de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

21 de março de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de março de 2018

Primeira postagem (Real)

29 de março de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de junho de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de maio de 2019

Última verificação

1 de maio de 2019

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 201711117

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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 .

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