Gynecologic Oncology PatientPhase 1NCT03481127
Psychological Services Integration in Gynecological Oncology Clinics
A Phase 1 study testing Integrated psychological care, Surveys and Blood draw in people with Gynecologic Oncology Patient, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gynecologic Oncology Patient
- What is being tested?
- Integrated psychological care, Surveys and Blood draw
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2018to 26 Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- -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)
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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.
- Conditions
- Gynecologic Oncology Patient
- Being tested
- Integrated psychological care, Surveys, Blood draw, Fresh tissue from ovary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated psychological careBehavioural
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.
SurveysOther
- NCCN Distress Thermometer
- PROMIS Depression \& Anxiety
- Quality of Life (SF-12)
- Brief COPE
- Patient awareness and satisfaction survey
Blood drawProcedure or surgery
- For patients with ovarian, fallopian tube, or primary peritoneal cysts
- Optional
- Enrollment, 3 months after enrollment, and 6 months after enrollment
Fresh tissue from ovaryProcedure or surgery
- For patients with ovarian, fallopian tube, or primary peritoneal cysts
- Optional
- At time of standard of care surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Usual Care | Active comparator | -No psychosocial care in clinic Receives: Other: Surveys; Procedure: Blood draw; Procedure: Fresh tissue from ovary |
| Arm 2: Integrated Care | Experimental | -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. Receives: Behavioral: Integrated psychological care; Other: Surveys; Procedure: Blood draw; Procedure: Fresh tissue from ovary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of integrating psychosocial care by a trained psychologist into gynecologic cancer outpatient clinics as measured by patient enrollment
-Willingness to participate with integrated care as quantified by proportion of enrolled patients from the number of approached eligible patients
Measured: Completion of patient enrollment (approximately 12 months)
Secondary outcomes (9)
Provider willingness to have a psychologist present
-5 item survey about willingness to have psychologist present in clinic
Measured: 6 months after start of study enrollment
Differences in clinic visit duration with and without a psychologist present
-Clinic visit duration is defined as the time from check-in to patient discharge
Measured: Day 1
Difference in psychological correlates of daily functioning as measured by patient distress between women who receive usual care versus integrated psychological care
- 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.
Measured: 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
- 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.
Measured: 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
- 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.
Measured: 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
- 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.
Measured: 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
- 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.
Measured: 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
- 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
Measured: 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
- 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
Measured: Enrollment, 3 months after enrollment, and 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start8 May 2018
- Primary completion29 Aug 2018
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic Oncology PatientStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Barnes-Jewish Hospital
- Responsible party
- Sponsor
- Investigators
- Jessica Vanderlan, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481127
- Sponsor's protocol ID
- 201711117
- Status last verified
- May 2019
- First submitted
- 21 Mar 2018
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of Psychological Services Integration in Gynecological Oncology Clinics
- ClinicalTrials.gov ID
- NCT03481127
- Acronym / sponsor ID
- 201711117
- Conditions
- Gynecologic Oncology Patient
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Barnes-Jewish Hospital
- Study start
- 8 May 2018 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Usual Care | Active comparator | Other: Surveys, Procedure: Blood draw, Procedure: Fresh tissue from ovary-No psychosocial care in clinic |
| Arm 2: Integrated Care | Experimental | Behavioral: Integrated psychological care, Other: Surveys, Procedure: Blood draw, Procedure: Fresh tissue from ovary-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- -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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated psychological careAdditional 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. | Behavioural | Arm 2: Integrated Care |
| Surveys* NCCN Distress Thermometer * PROMIS Depression \& Anxiety * Quality of Life (SF-12) * Brief COPE * Patient awareness and satisfaction survey | Other | Arm 1: Usual Care, Arm 2: Integrated Care |
| Blood draw* For patients with ovarian, fallopian tube, or primary peritoneal cysts * Optional * Enrollment, 3 months after enrollment, and 6 months after enrollment | Procedure or surgery | Arm 1: Usual Care, Arm 2: Integrated Care |
| Fresh tissue from ovary* For patients with ovarian, fallopian tube, or primary peritoneal cysts * Optional * At time of standard of care surgery | Procedure or surgery | Arm 1: Usual Care, Arm 2: Integrated Care |
Primary outcome
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
9 secondary outcomes
Provider willingness to have a psychologist present
Time frame: 6 months after start of study enrollment
Differences in clinic visit duration with and without a psychologist present
Time frame: Day 1
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Gynecologic Oncology Patient
RecruitingPhase 2
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
Active, not recruitingPhase 2
Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer
Ovarian Clear Cell Carcinoma, Gynecologic Cancer
Recruiting
PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving Platinum-based Chemotherapy
Gynecologic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Vanderlan, Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Integrated psychological care, Surveys and Blood draw in people with Gynecologic Oncology Patient, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.