Gynecologic CancerNCT04068675
Effects of Centering Pre-operative Counseling on Patient Reported Anxiety
A study testing Group pre-operative counseling in people with Gynecologic Cancer and Ovarian Cancer, run by Northwestern University at 1 site in United States.
Trial summary
The primary objective of the study is to evaluate the effect of pre-operative counseling in a group setting on patient reported anxiety for patients scheduled to undergo surgery for a known or suspected gynecologic malignancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Ovarian Cancer, Endometrial Cancer
- What is being tested?
- Group pre-operative counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2020to 30 Jun 2021
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women equal to or greater than 18 years old
- Fluent in English
- Known or suspected diagnosis of a gynecologic malignancy (ovarian, endometrial, uterine, and cervical cancers)
- Scheduled for major surgery at Northwestern Memorial Hospital/Prentice Women's Hospital (any laparotomy or laparoscopic or robotic assisted hysterectomy) within 4 weeks of study enrollment
- Internet access and ability to complete online survey and online counseling session
Who cannot join
- Under 18 years of age
- Adults unable to consent (cognitive impairment)
- Pregnant women
- Prisoners
- Urgent/Emergent surgery (surgery in less than 72 hours of consultation)
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of the study is to evaluate the effect of pre-operative counseling in a group setting on patient reported anxiety for patients scheduled to undergo surgery for a known or suspected gynecologic malignancy. Patient reported anxiety will be evaluated using a validated Patient-Reported Outcomes Measurement Information System (PROMIS) survey. We hypothesize that the group counseling session will reduce patient reported anxiety by a clinical meaningful level. Secondary objectives will evaluate the effect of the intervention on patient reported depression levels and compare adherence to Enhanced Recovery After Surgery (ERAS) instructions, utilization of unscheduled health care resources, and anxiety/depression levels to historical controls.
Read the detailed description
Comprehensive pre-operative counseling and education has been shown to play an important role in quality of life, anxiety and depression among cancer patients. Traditionally, patients are counseled in the office at the time of informed surgical consent. However there are several problems to this model including patient anxiety, confusion, information overload, and time constraints that may lead to sub-optimal counseling. Additionally, multiple studies have reported that patients forget half of what they have been told within 5 minutes of a health consultation and remember only 20% of the information passed on to them. Centering patient counseling has been used in other fields of medicine and has been shown to improve outcome in Obstetrics, Psychiatry, Gastroenterology, and Medical Oncology. In Obstetrics, centering pre-natal care with group counseling sessions has shown to be an effective model for improving perinatal outcomes and patient satisfaction. Pregnancy, not unlike cancer, is a medical condition that rapidly change's one life, is marred by anxiety, nervousness and innumerable potential symptoms. The rationale behind centering care is that providers can spend more time counseling and educating a larger audience at once, and it allows the whole group to benefit from individual questions, concerns, and complaints. Additionally, it establishes a network for patients to connect with other women going through similar stressors.
Prior to initiating this study, we conducted an Institutional Review Board exempt survey (STU00209351) of patients scheduled to undergo surgery with one of our Gynecologic Oncologists. Over 68% of patients expressed an interest in participating in a study to receive additional counseling. However, re-occurring themes that were mentioned were the time constraints and commuting issues in which patients experience in coming to our clinic in downtown Chicago. Given this feedback and the strong interest that our patient population has for this type of intervention, we have modified the traditional in-person centering model to an internet base, video conference group counseling session.
- Being tested
- Group pre-operative counseling
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group pre-operative counselingBehavioural
Enrolled patients will participate in a group pre-operative counseling session on the online conferencing platform BlueJeans® prior to their surgery. The sessions will not replace any portion of the pre-operative standard counseling and is designed to review and re-enforce the counseling already provided. The sessions will not review or discuss the specifics of any one individual's cancer or surgery. Rather the counseling session will focus on the universal instructions provided to all patients undergoing major surgery for a known or suspected gynecologic malignancy. The sessions will be led by a physician on a weekly basis with a minimal of three (3) enrolled patients per session and last approximately one (1) hour.
| Study group | Role | What they receive |
|---|---|---|
| Group counseling arm | Experimental | There is only one(1) arm in this study. All patients that enroll in the study will receive the group counseling intervention and be compared to historical controls. Receives: Behavioral: Group pre-operative counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety survey scores
The PROMIS Anxiety survey is a validated survey tool used to measure the severity of patient reported anxiety. Responses from the survey are converted to a T-score (scale: minimum score = 37.1, maximum score = 83.1) which have been standardized to the US general population with a mean 50 and standard deviation of 10. A score of less than 50 correlates to "normal" levels of anxiety, where as a score of 50-60 represents mild anxiety, 60-70 represents moderate anxiety, and >70 represents severe anxiety. PROMIS Anxiety scores will be evaluated at time of enrollment, after receiving the intervention, and four (4) weeks after surgery to evaluate for changes in anxiety scores.
Measured: It will take no more than 8 weeks to complete all survey related activities.
Secondary outcomes (4)
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression survey scores
The PROMIS Depression survey is a validated survey tool used to measure the severity of patient reported depression. Responses from the survey are converted to a T-score (scale: minimum score = 37.1, maximum score = 83.1) which have been standardized to the US general population with a mean 50 and standard deviation of 10. A score of less than 50 correlates to "normal" levels of depression, where as a score of 50-60 represents mild depression, 60-70 represents moderate depression, and >70 represents severe depression. PROMIS Depression scores will be evaluated at time of enrollment, after receiving the intervention, and four (4) weeks after surgery to evaluate for changes in depression scores.
Measured: It will take no more than 8 weeks to complete all survey related activities.
Hospital length of stay
The number of total days spent in the hospital after surgery until discharge
Measured: From surgery through study completion, an average of 4 weeks.
Enhanced Recovery After Surgery (ERAS) compliance
Compliance with ERAS instructions
Measured: From surgery through study completion, an average of 4 weeks.
Unscheduled health care resource use in the post-operative period
Use of unscheduled health care resources such as hospital re-admissions, ER visits, unscheduled clinic visits, problem-related phone calls and emails after surgery
Measured: From surgery through study completion, an average of 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start24 Feb 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emma Barber, Northwestern University
- Investigators
- Emma Barber, MD, MS, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068675
- Sponsor's protocol ID
- STU00209941
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2019
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Centering Pre-operative Counseling on Patient Reported Anxiety
- ClinicalTrials.gov ID
- NCT04068675
- Acronym / sponsor ID
- STU00209941
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 28 Aug 2019 (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 primary objective of the study is to evaluate the effect of pre-operative counseling in a group setting on patient reported anxiety for patients scheduled to undergo surgery for a known or suspected gynecologic malignancy. Patient reported anxiety will be evaluated using a validated Patient-Reported Outcomes Measurement Information System (PROMIS) survey. We hypothesize that the group counseling session will reduce patient reported anxiety by a clinical meaningful level. Secondary objectives will evaluate the effect of the intervention on patient reported depression levels and compare adherence to Enhanced Recovery After Surgery (ERAS) instructions, utilization of unscheduled health care resources, and anxiety/depression levels to historical controls.
Detailed description
Comprehensive pre-operative counseling and education has been shown to play an important role in quality of life, anxiety and depression among cancer patients. Traditionally, patients are counseled in the office at the time of informed surgical consent. However there are several problems to this model including patient anxiety, confusion, information overload, and time constraints that may lead to sub-optimal counseling. Additionally, multiple studies have reported that patients forget half of what they have been told within 5 minutes of a health consultation and remember only 20% of the information passed on to them. Centering patient counseling has been used in other fields of medicine and has been shown to improve outcome in Obstetrics, Psychiatry, Gastroenterology, and Medical Oncology. In Obstetrics, centering pre-natal care with group counseling sessions has shown to be an effective model for improving perinatal outcomes and patient satisfaction. Pregnancy, not unlike cancer, is a medical condition that rapidly change's one life, is marred by anxiety, nervousness and innumerable potential symptoms. The rationale behind centering care is that providers can spend more time counseling and educating a larger audience at once, and it allows the whole group to benefit from individual questions, concerns, and complaints. Additionally, it establishes a network for patients to connect with other women going through similar stressors.
Prior to initiating this study, we conducted an Institutional Review Board exempt survey (STU00209351) of patients scheduled to undergo surgery with one of our Gynecologic Oncologists. Over 68% of patients expressed an interest in participating in a study to receive additional counseling. However, re-occurring themes that were mentioned were the time constraints and commuting issues in which patients experience in coming to our clinic in downtown Chicago. Given this feedback and the strong interest that our patient population has for this type of intervention, we have modified the traditional in-person centering model to an internet base, video conference group counseling session.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group counseling arm | Experimental | Behavioral: Group pre-operative counselingThere is only one(1) arm in this study. All patients that enroll in the study will receive the group counseling intervention and be compared to historical controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women equal to or greater than 18 years old
- Fluent in English
- Known or suspected diagnosis of a gynecologic malignancy (ovarian, endometrial, uterine, and cervical cancers)
- Scheduled for major surgery at Northwestern Memorial Hospital/Prentice Women's Hospital (any laparotomy or laparoscopic or robotic assisted hysterectomy) within 4 weeks of study enrollment
- Internet access and ability to complete online survey and online counseling session
Key exclusion criteria (5 listed)
- Under 18 years of age
- Adults unable to consent (cognitive impairment)
- Pregnant women
- Prisoners
- Urgent/Emergent surgery (surgery in less than 72 hours of consultation)
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 |
|---|---|---|
| Group pre-operative counselingEnrolled patients will participate in a group pre-operative counseling session on the online conferencing platform BlueJeans® prior to their surgery. The sessions will not replace any portion of the pre-operative standard counseling and is designed to review and re-enforce the counseling already provided. The sessions will not review or discuss the specifics of any one individual's cancer or surgery. Rather the counseling session will focus on the universal instructions provided to all patients undergoing major surgery for a known or suspected gynecologic malignancy. The sessions will be led by a physician on a weekly basis with a minimal of three (3) enrolled patients per session and last approximately one (1) hour. | Behavioural | Group counseling arm |
Primary outcome
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety survey scores
Time frame: It will take no more than 8 weeks to complete all survey related activities.
The PROMIS Anxiety survey is a validated survey tool used to measure the severity of patient reported anxiety. Responses from the survey are converted to a T-score (scale: minimum score = 37.1, maximum score = 83.1) which have been standardized to the US general population with a mean 50 and standard deviation of 10. A score of less than 50 correlates to "normal" levels of anxiety, where as a score of 50-60 represents mild anxiety, 60-70 represents moderate anxiety, and >70 represents severe anxiety. PROMIS Anxiety scores will be evaluated at time of enrollment, after receiving the intervention, and four (4) weeks after surgery to evaluate for changes in anxiety scores.
4 secondary outcomes
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression survey scores
Time frame: It will take no more than 8 weeks to complete all survey related activities.
Hospital length of stay
Time frame: From surgery through study completion, an average of 4 weeks.
Enhanced Recovery After Surgery (ERAS) compliance
Time frame: From surgery through study completion, an average of 4 weeks.
Unscheduled health care resource use in the post-operative period
Time frame: From surgery through study completion, an average of 4 weeks.
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 17 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Emma Barber, MD, MS principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group pre-operative counseling in people with Gynecologic Cancer and Ovarian Cancer, run by Northwestern University 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 5 inclusion and 5 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 17 Aug 2021. 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.
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?
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety survey scores (time frame: It will take no more than 8 weeks to complete all survey related activities.). 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 17 Aug 2021.