CancerNCT03304145
Shared Decision Making in Pain Management Planning in Patients With Cancer
A study testing The Carevive CPS in people with Cancer, run by Carevive Systems, Inc. at 1 site in United States.
Trial summary
The goal of this project is to evaluate the effectiveness of shared-decision-making (SDM) to manage chronic and breakthrough pain in patients with cancer. Providers will receive evidence-based education on shared decision-making strategies and comprehensive pain management at study start up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- The Carevive CPS
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 24 Feb 2020
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants must be 18 years of age or older.
- Patient participants must have a diagnosis of cancer
- Patients must have screened positive for pain per a previous clinical assessment
- All participants must be able to understand English.
Who cannot join
- Any patient who cannot understand written or spoken English.
- Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this project is to evaluate the effectiveness of shared-decision-making (SDM) to manage chronic and breakthrough pain in patients with cancer. Providers will receive evidence-based education on shared decision-making strategies and comprehensive pain management at study start up. In addition, the information will be available on the Carevive platform for reference at the point of care. This multisite study will enroll 105 patients from three cancer institutions. This project will explore the SDM model using a touchscreen-based expanded pain assessment (EPA) to evaluate the impact of the shared-decision-making model on pain management, and explore its relationship to pain management care planning. Patients will use the Carevive Systems software in the clinic to answer questions regarding decision making preferences and complete a comprehensive assessment of their pain status. Treatment recommendations and a care plan will be provided to the patient at the time of the visit. At each clinic visit over 4 months, the patient will again complete the pain assessment and receive appropriate treatment recommendations and a revised care plan.
Read the detailed description
Cancer-related pain is a significant clinical challenge that impacts patient outcomes and remains a significant problem for patients with cancer and their providers. The overall prevalence of cancer pain is high; a recent meta-analysis of 52 studies reported cancer pain prevalence ranging between 52%-77%. Another update reports rates of 39% after curative treatment, 55% during treatment, and 66% in advanced, metastatic or terminal disease. Moderate to severe pain was reported by 38% of all patients. Cancer pain may be cancer related, due to tumor burden causing bone, nerve, and/or organ compression, and/or treatment related, due to procedures, surgery, and side effects of chemotherapy or radiation. The prevalence of pain after breast cancer treatment ranges from 13%-93%; women with metastatic breast cancer often have bone pain from metastases and bisphosphonates. In a nationwide lung cancer study (N = 450), pain was reported by 92% of patients with advanced (stage IIIB/IV) NSCLC. Similar reports indicate pain ranges from 74% to 92%. Uncontrolled pain is the most common chief complaint of unplanned hospitalizations and readmissions. One study reported over half of the chief complaints provided by breast cancer patients with an emergency department (ED) visit were related to poorly controlled pain, respiratory or gastrointestinal symptoms. Finally, there is evidence that high symptom burden and poor management of symptoms and side effects also leads to suboptimal adherence to therapy.
Management of cancer pain requires that the patient be screened for the presence of pain at every clinical contact. A comprehensive assessment should be conducted if the patient is experiencing pain, including specific questions about location, duration, severity, quality, timing, duration, and impact on quality of life. A thorough understanding of pain also considers the temporal characteristics of the pain experience, determining if the pain is intermittent, that is bursts of severe pain without persistent chronic pain, persistent, with moderate to severe pain present throughout the day, and/or breakthrough pain described as the transient exacerbation of pain despite adequately controlled persistent pain. Breakthrough pain is reported to occur daily in 21%-70% of patients.
The prevalence of psychosocial and physical symptom distress in cancer is so compelling that the Commission on Cancer, the Oncology Nursing Society (ONS), American Society of Clinical Oncology (ASCO), and the National Committee for Quality Assurance (NCQA)'s Patient-Centered Oncology Care Standards all require distress screening that includes pain screening and assessment as a quality mandate in their accreditation and quality certification programs. In addition, the Centers for Medicare and Medicaid Services (CMMS)'s Oncology Care Model (OCM) requires a care management plan that includes symptom management. Included as quality measures are NQF384, pain intensity quantified, and NQF 383, plan of care for pain. In addition, value based care payment models seek to decrease emergency department (ED) visits and hospitalization days.
Carevive recently completed a project designed to improve adherence to quality metrics in breast cancer through education plus use of a tablet-based technology to screen for and manage identified distress, pain, and other breast cancer quality indicators available within ASCO's Quality Oncology Practice Initiative (QOPI) program. The Breast National Quality Standards project used QOPI metrics to evaluate outcomes of a CME intervention and use of the Carevive CPS. Preliminary data from this project showed improvement in key areas. Provider adherence to quality metrics was measured in 151 non-metastatic BC patients, 77 of which served as historical controls with no CME/clinical intervention, and 74 received the intervention after their provider participated in certified continuing medical education (CME) activities designed to educate about evidence-based assessment, decision-making, and management strategies for BC patients. Preliminary analysis showed that the intervention improved provider adherence to four pain quality measures: a. pain assessed by second office visit, b) pain intensity quantified by second office visit, c) plan of care documented, and d) pain assessed on either of the two most recent office visits. This project will build on that work to incorporate a comprehensive assessment and a more multi-faceted intervention that engages the care team in a SDM process around cancer pain management.
Along with an imperative to formalize a pain management plan is the rising importance of incorporating shared-decision-making, the cornerstone of patient centered care, into all care decisions. When making treatment decisions, the provider must incorporate current literature, patients' current clinical status, and patient preferences. One challenge with measuring quality through electronic chart abstraction is the difficulty of identifying when patient preference has influenced treatment decisions. Little data currently exist on the level of patient engagement in decision-making for pain management and the perception of patients with MBC, LC, or AC of shared-decision-making in developing a pain management care plan. Dr. Jeannine Brant and colleagues have developed the Pain Care Quality Survey (PainCQ©). The PainCQs are two tools that measure the quality of nursing and interdisciplinary care related to pain management as perceived by hospitalized individuals. These tools will be modified in this project to capture the variable contributions of different members in the care team, including oncology nursing staff.
Strategies to better manage chronic and breakthrough cancer pain are critical. Many cancer centers have incorporated distress screening using either the National Comprehensive Cancer Network (NCCN) Distress Thermometer or the Edmonton Symptom Assessment Scale (ESAS) tools. However, structured processes are typically lacking within the clinical workflow to seamlessly integrate and conduct a more in-depth assessment of those patients who score positively for pain. Processes and technologies that facilitate better integration of pain assessment and pain management care strategies into the oncology team's clinical workflow, while simultaneously integrating algorithms for treatment of pain have the potential to further drive evidence-based care.
- Conditions
- Cancer
- Being tested
- The Carevive CPS
- Keywords
- Treatment Care Planning
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Carevive CPSOther
The Carevive Care Planning System (CPS) was developed to overcome challenges by providing an efficient, clinically integrated solution for both psychosocial and physical symptom distress screening and management through the delivery of personalized and evidence-based care plans at the point of care. The Carevive CPS simultaneously collects and aggregates discrete data for quality reporting and improvement.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of pain care plan on pain outcomes
Pain intensity over time will be measured by the Sum of Pain Intensity Differences (SPID).
Measured: Year 1
Secondary outcomes (2)
Contribution of shared-decision-making on pain outcomes will be evaluated using the PainCQ© surveys
The PainCQ measures the patient's perception of the quality of pain management by the interdisciplinary team and whether the patient felt included in decision making.
Measured: Year 1
Feasibility of the proposed shared decision-making model to effectively manage chronic pain experienced by patients with cancer
Participating OCM practices will complete a single feasibility assessment measuring completeness of each intervention tool
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start1 Oct 2017
- Primary completion31 Aug 2018
- Study completion24 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carevive Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304145
- Sponsor's protocol ID
- G414
- Status last verified
- Feb 2020
- First submitted
- 18 Sep 2017
- Last updated
- 25 Feb 2020
- 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 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making in Pain Management Planning in Patients With Cancer
- ClinicalTrials.gov ID
- NCT03304145
- Acronym / sponsor ID
- G414
- Conditions
- Cancer
- Keywords
- Treatment Care Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Carevive Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 6 Oct 2017 (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 goal of this project is to evaluate the effectiveness of shared-decision-making (SDM) to manage chronic and breakthrough pain in patients with cancer. Providers will receive evidence-based education on shared decision-making strategies and comprehensive pain management at study start up. In addition, the information will be available on the Carevive platform for reference at the point of care. This multisite study will enroll 105 patients from three cancer institutions. This project will explore the SDM model using a touchscreen-based expanded pain assessment (EPA) to evaluate the impact of the shared-decision-making model on pain management, and explore its relationship to pain management care planning. Patients will use the Carevive Systems software in the clinic to answer questions regarding decision making preferences and complete a comprehensive assessment of their pain status. Treatment recommendations and a care plan will be provided to the patient at the time of the visit. At each clinic visit over 4 months, the patient will again complete the pain assessment and receive appropriate treatment recommendations and a revised care plan.
Detailed description
Cancer-related pain is a significant clinical challenge that impacts patient outcomes and remains a significant problem for patients with cancer and their providers. The overall prevalence of cancer pain is high; a recent meta-analysis of 52 studies reported cancer pain prevalence ranging between 52%-77%. Another update reports rates of 39% after curative treatment, 55% during treatment, and 66% in advanced, metastatic or terminal disease. Moderate to severe pain was reported by 38% of all patients. Cancer pain may be cancer related, due to tumor burden causing bone, nerve, and/or organ compression, and/or treatment related, due to procedures, surgery, and side effects of chemotherapy or radiation. The prevalence of pain after breast cancer treatment ranges from 13%-93%; women with metastatic breast cancer often have bone pain from metastases and bisphosphonates. In a nationwide lung cancer study (N = 450), pain was reported by 92% of patients with advanced (stage IIIB/IV) NSCLC. Similar reports indicate pain ranges from 74% to 92%. Uncontrolled pain is the most common chief complaint of unplanned hospitalizations and readmissions. One study reported over half of the chief complaints provided by breast cancer patients with an emergency department (ED) visit were related to poorly controlled pain, respiratory or gastrointestinal symptoms. Finally, there is evidence that high symptom burden and poor management of symptoms and side effects also leads to suboptimal adherence to therapy.
Management of cancer pain requires that the patient be screened for the presence of pain at every clinical contact. A comprehensive assessment should be conducted if the patient is experiencing pain, including specific questions about location, duration, severity, quality, timing, duration, and impact on quality of life. A thorough understanding of pain also considers the temporal characteristics of the pain experience, determining if the pain is intermittent, that is bursts of severe pain without persistent chronic pain, persistent, with moderate to severe pain present throughout the day, and/or breakthrough pain described as the transient exacerbation of pain despite adequately controlled persistent pain. Breakthrough pain is reported to occur daily in 21%-70% of patients.
The prevalence of psychosocial and physical symptom distress in cancer is so compelling that the Commission on Cancer, the Oncology Nursing Society (ONS), American Society of Clinical Oncology (ASCO), and the National Committee for Quality Assurance (NCQA)'s Patient-Centered Oncology Care Standards all require distress screening that includes pain screening and assessment as a quality mandate in their accreditation and quality certification programs. In addition, the Centers for Medicare and Medicaid Services (CMMS)'s Oncology Care Model (OCM) requires a care management plan that includes symptom management. Included as quality measures are NQF384, pain intensity quantified, and NQF 383, plan of care for pain. In addition, value based care payment models seek to decrease emergency department (ED) visits and hospitalization days.
Carevive recently completed a project designed to improve adherence to quality metrics in breast cancer through education plus use of a tablet-based technology to screen for and manage identified distress, pain, and other breast cancer quality indicators available within ASCO's Quality Oncology Practice Initiative (QOPI) program. The Breast National Quality Standards project used QOPI metrics to evaluate outcomes of a CME intervention and use of the Carevive CPS. Preliminary data from this project showed improvement in key areas. Provider adherence to quality metrics was measured in 151 non-metastatic BC patients, 77 of which served as historical controls with no CME/clinical intervention, and 74 received the intervention after their provider participated in certified continuing medical education (CME) activities designed to educate about evidence-based assessment, decision-making, and management strategies for BC patients. Preliminary analysis showed that the intervention improved provider adherence to four pain quality measures: a. pain assessed by second office visit, b) pain intensity quantified by second office visit, c) plan of care documented, and d) pain assessed on either of the two most recent office visits. This project will build on that work to incorporate a comprehensive assessment and a more multi-faceted intervention that engages the care team in a SDM process around cancer pain management.
Along with an imperative to formalize a pain management plan is the rising importance of incorporating shared-decision-making, the cornerstone of patient centered care, into all care decisions. When making treatment decisions, the provider must incorporate current literature, patients' current clinical status, and patient preferences. One challenge with measuring quality through electronic chart abstraction is the difficulty of identifying when patient preference has influenced treatment decisions. Little data currently exist on the level of patient engagement in decision-making for pain management and the perception of patients with MBC, LC, or AC of shared-decision-making in developing a pain management care plan. Dr. Jeannine Brant and colleagues have developed the Pain Care Quality Survey (PainCQ©). The PainCQs are two tools that measure the quality of nursing and interdisciplinary care related to pain management as perceived by hospitalized individuals. These tools will be modified in this project to capture the variable contributions of different members in the care team, including oncology nursing staff.
Strategies to better manage chronic and breakthrough cancer pain are critical. Many cancer centers have incorporated distress screening using either the National Comprehensive Cancer Network (NCCN) Distress Thermometer or the Edmonton Symptom Assessment Scale (ESAS) tools. However, structured processes are typically lacking within the clinical workflow to seamlessly integrate and conduct a more in-depth assessment of those patients who score positively for pain. Processes and technologies that facilitate better integration of pain assessment and pain management care strategies into the oncology team's clinical workflow, while simultaneously integrating algorithms for treatment of pain have the potential to further drive evidence-based care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All participants must be 18 years of age or older.
- Patient participants must have a diagnosis of cancer
- Patients must have screened positive for pain per a previous clinical assessment
- All participants must be able to understand English.
Key exclusion criteria (2 listed)
- Any patient who cannot understand written or spoken English.
- Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
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 |
|---|---|---|
| The Carevive CPSThe Carevive Care Planning System (CPS) was developed to overcome challenges by providing an efficient, clinically integrated solution for both psychosocial and physical symptom distress screening and management through the delivery of personalized and evidence-based care plans at the point of care. The Carevive CPS simultaneously collects and aggregates discrete data for quality reporting and improvement. | Other | – |
Primary outcome
Effect of pain care plan on pain outcomes
Time frame: Year 1
Pain intensity over time will be measured by the Sum of Pain Intensity Differences (SPID).
2 secondary outcomes
Contribution of shared-decision-making on pain outcomes will be evaluated using the PainCQ© surveys
Time frame: Year 1
Feasibility of the proposed shared decision-making model to effectively manage chronic pain experienced by patients with cancer
Time frame: Year 1
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 25 Feb 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Carevive CPS in people with Cancer, run by Carevive Systems, Inc. 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 4 inclusion and 2 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 25 Feb 2020. 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?
Effect of pain care plan on pain outcomes (time frame: Year 1). 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 25 Feb 2020.