- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03481127
Psychological Services Integration in Gynecological Oncology Clinics
Implementation and Evaluation of Psychological Services Integration in Gynecological Oncology Clinics
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
Missouri
-
Saint Louis, Missouri, Förenta staterna, 63110
- Washington University School of Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Arm 1: Usual Care
-No psychosocial care in clinic
|
|
Experimentell: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Feasibility of integrating psychosocial care by a trained psychologist into gynecologic cancer outpatient clinics as measured by patient enrollment
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Provider willingness to have a psychologist present
Tidsram: 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
Tidsram: 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
Tidsram: Enrollment, 3 months after enrollment, and 6 months after enrollment
|
|
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
Tidsram: Enrollment, 3 months after enrollment, and 6 months after enrollment
|
|
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
Tidsram: Enrollment, 3 months after enrollment, and 6 months after enrollment
|
|
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
Tidsram: Enrollment, 3 months after enrollment, and 6 months after enrollment
|
|
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
Tidsram: Enrollment, 3 months after enrollment, and 6 months after enrollment
|
|
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
Tidsram: Enrollment, 3 months after enrollment, and 6 months after enrollment
|
|
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
Tidsram: Enrollment, 3 months after enrollment, and 6 months after enrollment
|
|
Enrollment, 3 months after enrollment, and 6 months after enrollment
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Jessica Vanderlan, Ph.D., Washington University School of Medicine
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 201711117
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
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