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Psychological Services Integration in Gynecological Oncology Clinics

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ClinicalTrials.gov Identifier: NCT03481127
Recruitment Status : Active, not recruiting
First Posted : March 29, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
Barnes-Jewish Hospital
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gynecologic Oncology Patient Behavioral: Integrated psychological care Other: Surveys Procedure: Blood draw Procedure: Fresh tissue from ovary Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Implementation and Evaluation of Psychological Services Integration in Gynecological Oncology Clinics
Actual Study Start Date : May 8, 2018
Actual Primary Completion Date : August 29, 2018
Estimated Study Completion Date : February 28, 2019

Arm Intervention/treatment
Active Comparator: Arm 1: Usual Care
-No psychosocial care in clinic
Other: 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

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.
Behavioral: 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.

Other: 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




Primary Outcome Measures :
  1. Feasibility of integrating psychosocial care by a trained psychologist into gynecologic cancer outpatient clinics as measured by patient enrollment [ Time Frame: 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


Secondary Outcome Measures :
  1. Provider willingness to have a psychologist present [ Time Frame: 6 months after start of study enrollment ]
    -5 item survey about willingness to have psychologist present in clinic

  2. Differences in clinic visit duration with and without a psychologist present [ Time Frame: Day 1 ]
    -Clinic visit duration is defined as the time from check-in to patient discharge

  3. Difference in psychological correlates of daily functioning as measured by patient distress between women who receive usual care versus integrated psychological care [ Time Frame: 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.

  4. Difference in psychological correlates of daily functioning as measured by patient depression between women who receive usual care versus integrated psychological care [ Time Frame: 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.

  5. Difference in psychological correlates of daily functioning as measured by patient anxiety between women who receive usual care versus integrated psychological care [ Time Frame: 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.

  6. Difference in psychological correlates of daily functioning as measured by patient quality of life between women who receive usual care versus integrated psychological care [ Time Frame: 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.

  7. Difference in psychological correlates of daily functioning as measured by patient coping mechanisms between women who receive usual care versus integrated psychological care [ Time Frame: 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.

  8. 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 [ Time Frame: 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

  9. 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 [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481127


Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Barnes-Jewish Hospital
Investigators
Principal Investigator: Jessica Vanderlan, Ph.D. Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03481127     History of Changes
Other Study ID Numbers: 201711117
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms