Uterine Cervical NeoplasmsNCT02786524
Effect of Outpatient Symptom Management on Gynecologic Oncology Patients Receiving Chemotherapy
A study testing Specialized Symptom Management and Supportive Care in people with Uterine Cervical Neoplasms and Ovarian Neoplasms, run by University of Michigan at 1 site in United States.
Trial summary
To evaluate whether formal referral to The Symptom Management and Supportive Care Clinic improves symptom burden in advanced stage or recurrent gynecologic oncology chemotherapy patients compared with symptom management performed by the primary gynecologic oncologist. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Neoplasms, Ovarian Neoplasms, Gynecologic Neoplasms
- What is being tested?
- Specialized Symptom Management and Supportive Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2016to 31 Oct 2017
- 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
- Female
- 18 years of age or older
- Diagnosis of Stage III, IV, or recurrent gynecologic malignancy (Uterine, Ovarian, Cervical, Vulvar, Vaginal, Fallopian Tube, Primary Peritoneal)
- Receiving active intravenous, intraperitoneal, or oral chemotherapy
- Patient at University of Michigan Gynecologic Oncology Clinic
Who cannot join
- Male
- Less than 18 years of age
- Patients without a diagnosis of a gynecologic malignancy
- Patients not receiving intravenous, intraperitoneal or oral chemotherapy at the time of enrollment
- Patients receiving radiation therapy with chemo-sensitization.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: A Randomized Study to Evaluate the Effect of Outpatient Symptom Management on Symptom Burden in Advanced Stage or Recurrent Gynecologic Oncology Patients Receiving Chemotherapy
To evaluate whether formal referral to The Symptom Management and Supportive Care Clinic improves symptom burden in advanced stage or recurrent gynecologic oncology chemotherapy patients compared with symptom management performed by the primary gynecologic oncologist.
Read the detailed description
Patients with gynecologic malignancies often have a high prevalence of symptoms throughout their disease course including fatigue, pain, anxiety and depression. Palliative care is defined by the World Health Organization (WHO) as "an approach that improves the quality of life of patients and their families facing the problems associated with life threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual."
The University of Michigan Symptom Management and Supportive Care Program works together with patient's oncology team to manage cancer related and treatment related symptoms. They offer a wide range of services including: pain and symptom management, medication management, nutritional counseling, expedited access to psychiatric oncology, anesthesia pain service and physical medicine and rehabilitation. Studies have demonstrated an improvement in quality of life, symptom burden and patient/care giver satisfaction when palliative care is part of routine oncologic care. Currently, in gynecologic oncology, palliative care is incorporated on a case by case basis, instead of in a standardized approach. We hope this study will provide a standardized tool to identify gynecologic oncology patients receiving chemotherapy who would benefit from a referral to a symptom management clinic.
This study will provide a screening mechanism to identify advanced stage or recurrent gynecologic oncology chemotherapy patients with palliative care needs and determine which symptom management option provides the best improvement in symptom burden, that performed by a specialty clinic staffed by providers formally trained in palliative care or that provided by the patient's gynecologic oncologist. This study has the potential to change practice by providing a triage tool that will identify patients that will most benefit from specialty palliative care services and could result in improved quality of life for our patients.
- Conditions
- Uterine Cervical Neoplasms, Ovarian Neoplasms, Gynecologic Neoplasms, Fallopian Tube Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms
- Being tested
- Specialized Symptom Management and Supportive Care
- Keywords
- Palliative Care, Triage, Symptom Evaluation, Chemotherapy, Patient Distress
- Medical subject headings
- Uterine Cervical Neoplasms, Ovarian Neoplasms, Genital Neoplasms, Female, Fallopian Tube Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized Symptom Management and Supportive CareBehavioural
Based on Patients who score 5 or higher on the Baseline Patient Palliative Care Survey that will identify patients that will most benefit from specialty palliative care
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Patients randomized to this arm receive standard symptom management care by their primary gynecologic oncologist and complete the NCCN distress thermometer and ESAS-r at each visit, every 3-4 weeks. |
| Symptom Management and Supportive Care | Experimental | Patients randomized to this arm are referred to a specialized symptom management and supportive care clinic and seen within two weeks. Patients will be seen in follow-up as recommended by the symptom management providers, and at each visit they will complete the ESAS-r and NCCN distress thermometer and return their responses either in person or by mail to the study team in a pre-addressed postage paid envelope. Receives: Behavioral: Specialized Symptom Management and Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-Reported Symptom Burden as Determined by the Edmonton Symptom Assessment System
To determine if referral to a symptom management clinic improves the symptom burden quantified by the patients' Edmonton Symptom Assessment System (ESAS) scores.
Measured: Baseline and 3 months after study start
Change in Patient-Reported Symptom Burden as Determined by the National Comprehensive Cancer Network Distress Screening Tool
To determine if referral to a symptom management clinic improves the symptom burden quantified by the patients' National Comprehensive Cancer Network (NCCN) Distress Screening Tool scores.
Measured: Baseline and 3 months after study start
Secondary outcomes (6)
Baseline Symptom Burden and Palliative Care Needs
To determine the baseline symptom burden and palliative care needs upon enrollment of patients with advanced stage or recurrent gynecologic malignancies receiving chemotherapy.
Measured: Baseline
Change in Patient-Reported Distress
Measure changes in patient-reported distress using the NCCN Distress Thermometer
Measured: 3 months after study start, 6 months after study start, and 9 months after study start
Change in Symptom Burden
Evaluate changes in patients' symptom burden with the ESAS-r to evaluate the ongoing sustained effect of the intervention.
Measured: 6 months after study start and 9 months after study start
Change in Patient Adherence to Symptom Management Program
To analyze patients in the symptom management arms with a 3-item questionnaire to determine what factors are associated with adherence to a symptom management program.
Measured: 6 months after study start and 9 months after study start
Barriers to Symptom Management and Supportive Care
Analyze barriers that prevented patients from attending the Symptom Management and Supportive Care Clinic, as identified in a 3-item questionnaire.
Measured: 9 months after study start
Overall Survival Rate
Overall survival will be compared between the two study arms.
Measured: Upon study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start15 Feb 2016
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Harris, University of Michigan
- Investigators
- Katherine Harris, MD, Principal investigator, University of MichiganCarolyn M Johnston, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786524
- Sponsor's protocol ID
- HUM00089412
- Status last verified
- Mar 2019
- First submitted
- 10 May 2016
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Evaluate the Effect of Outpatient Symptom Management on Symptom Burden in Advanced Stage or Recurrent Gynecologic Oncology Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT02786524
- Acronym / sponsor ID
- HUM00089412
- Conditions
- Uterine Cervical Neoplasms, Ovarian Neoplasms, Gynecologic Neoplasms, Fallopian Tube Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms
- Keywords
- Palliative Care, Triage, Symptom Evaluation, Chemotherapy, Patient Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 1 Jun 2016 (estimated)
- 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.
To evaluate whether formal referral to The Symptom Management and Supportive Care Clinic improves symptom burden in advanced stage or recurrent gynecologic oncology chemotherapy patients compared with symptom management performed by the primary gynecologic oncologist.
Detailed description
Patients with gynecologic malignancies often have a high prevalence of symptoms throughout their disease course including fatigue, pain, anxiety and depression. Palliative care is defined by the World Health Organization (WHO) as "an approach that improves the quality of life of patients and their families facing the problems associated with life threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual."
The University of Michigan Symptom Management and Supportive Care Program works together with patient's oncology team to manage cancer related and treatment related symptoms. They offer a wide range of services including: pain and symptom management, medication management, nutritional counseling, expedited access to psychiatric oncology, anesthesia pain service and physical medicine and rehabilitation. Studies have demonstrated an improvement in quality of life, symptom burden and patient/care giver satisfaction when palliative care is part of routine oncologic care. Currently, in gynecologic oncology, palliative care is incorporated on a case by case basis, instead of in a standardized approach. We hope this study will provide a standardized tool to identify gynecologic oncology patients receiving chemotherapy who would benefit from a referral to a symptom management clinic.
This study will provide a screening mechanism to identify advanced stage or recurrent gynecologic oncology chemotherapy patients with palliative care needs and determine which symptom management option provides the best improvement in symptom burden, that performed by a specialty clinic staffed by providers formally trained in palliative care or that provided by the patient's gynecologic oncologist. This study has the potential to change practice by providing a triage tool that will identify patients that will most benefit from specialty palliative care services and could result in improved quality of life for our patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Patients randomized to this arm receive standard symptom management care by their primary gynecologic oncologist and complete the NCCN distress thermometer and ESAS-r at each visit, every 3-4 weeks. |
| Symptom Management and Supportive Care | Experimental | Behavioral: Specialized Symptom Management and Supportive CarePatients randomized to this arm are referred to a specialized symptom management and supportive care clinic and seen within two weeks. Patients will be seen in follow-up as recommended by the symptom management providers, and at each visit they will complete the ESAS-r and NCCN distress thermometer and return their responses either in person or by mail to the study team in a pre-addressed postage paid envelope. |
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)
- Female
- 18 years of age or older
- Diagnosis of Stage III, IV, or recurrent gynecologic malignancy (Uterine, Ovarian, Cervical, Vulvar, Vaginal, Fallopian Tube, Primary Peritoneal)
- Receiving active intravenous, intraperitoneal, or oral chemotherapy
- Patient at University of Michigan Gynecologic Oncology Clinic
Key exclusion criteria (5 listed)
- Male
- Less than 18 years of age
- Patients without a diagnosis of a gynecologic malignancy
- Patients not receiving intravenous, intraperitoneal or oral chemotherapy at the time of enrollment
- Patients receiving radiation therapy with chemo-sensitization.
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 |
|---|---|---|
| Specialized Symptom Management and Supportive CareBased on Patients who score 5 or higher on the Baseline Patient Palliative Care Survey that will identify patients that will most benefit from specialty palliative care | Behavioural | Symptom Management and Supportive Care |
Primary outcome
Change in Patient-Reported Symptom Burden as Determined by the Edmonton Symptom Assessment System
Time frame: Baseline and 3 months after study start
To determine if referral to a symptom management clinic improves the symptom burden quantified by the patients' Edmonton Symptom Assessment System (ESAS) scores.
Change in Patient-Reported Symptom Burden as Determined by the National Comprehensive Cancer Network Distress Screening Tool
Time frame: Baseline and 3 months after study start
To determine if referral to a symptom management clinic improves the symptom burden quantified by the patients' National Comprehensive Cancer Network (NCCN) Distress Screening Tool scores.
6 secondary outcomes
Baseline Symptom Burden and Palliative Care Needs
Time frame: Baseline
Change in Patient-Reported Distress
Time frame: 3 months after study start, 6 months after study start, and 9 months after study start
Change in Symptom Burden
Time frame: 6 months after study start and 9 months after study start
Change in Patient Adherence to Symptom Management Program
Time frame: 6 months after study start and 9 months after study start
Barriers to Symptom Management and Supportive Care
Time frame: 9 months after study start
Overall Survival Rate
Time frame: Upon study completion, an average of 1 year
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 21 Mar 2019.
- 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.
Katherine Harris, MD principal investigator
University of Michigan
Carolyn M Johnston, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specialized Symptom Management and Supportive Care in people with Uterine Cervical Neoplasms and Ovarian Neoplasms, run by University of Michigan 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 21 Mar 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.
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?
Change in Patient-Reported Symptom Burden as Determined by the Edmonton Symptom Assessment System (time frame: Baseline and 3 months after study start). The study lists 2 primary outcomes in all. 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 21 Mar 2019.