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Psychological Services Integration in Gynecological Oncology Clinics

30 mei 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

101

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Missouri
      • Saint Louis, Missouri, Verenigde Staten, 63110
        • Washington University School of Medicine

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Arm 1: Usual Care
-No psychosocial care in clinic
Ander: Surveys
  • NCCN Distress Thermometer
  • PROMIS Depression & Anxiety
  • Quality of Life (SF-12)
  • Brief COPE
  • Patient awareness and satisfaction survey
Procedure: Blood draw
  • For patients with ovarian, fallopian tube, or primary peritoneal cysts
  • Optional
  • Enrollment, 3 months after enrollment, and 6 months after enrollment
Procedure: Fresh tissue from ovary
  • For patients with ovarian, fallopian tube, or primary peritoneal cysts
  • Optional
  • At time of standard of care surgery
Experimenteel: 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.
Ander: Surveys
  • NCCN Distress Thermometer
  • PROMIS Depression & Anxiety
  • Quality of Life (SF-12)
  • Brief COPE
  • Patient awareness and satisfaction survey
Procedure: Blood draw
  • For patients with ovarian, fallopian tube, or primary peritoneal cysts
  • Optional
  • Enrollment, 3 months after enrollment, and 6 months after enrollment
Procedure: Fresh tissue from ovary
  • For patients with ovarian, fallopian tube, or primary peritoneal cysts
  • Optional
  • At time of standard of care surgery
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Feasibility of integrating psychosocial care by a trained psychologist into gynecologic cancer outpatient clinics as measured by patient enrollment
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Provider willingness to have a psychologist present
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Washington University School of Medicine

Medewerkers

Barnes-Jewish Hospital

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 mei 2018

Primaire voltooiing (Werkelijk)

29 augustus 2018

Studie voltooiing (Werkelijk)

26 maart 2019

Studieregistratiedata

Eerst ingediend

21 maart 2018

Eerst ingediend dat voldeed aan de QC-criteria

21 maart 2018

Eerst geplaatst (Werkelijk)

29 maart 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 juni 2019

Laatste update ingediend die voldeed aan QC-criteria

30 mei 2019

Laatst geverifieerd

1 mei 2019

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 201711117

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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