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| ID | Type | Description | Link |
|---|---|---|---|
| R33CA278594 | U.S. NIH Grant/Contract | View source | |
| 23-010838 | Other Identifier | Mayo Clinic Institutional Review Board |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial tests a collaborative pain management intervention (ASCENT) for improving cancer pain in cancer survivors. Cancer pain is prevalent, under-treated, and remains a major cause of suffering, impairment, and disability for millions of Americans. Individual pain interventions and care models show promise for cancer pain in controlled settings. All cancer survivors stand to benefit from electronic health record innovations, as they can experience profound pain outcomes, including marked under- and over-prescribing of opioids. Digitally facilitated solutions are especially helpful and can be customized to address patient needs. The ASCENT intervention provides patients with an educational guide that describes techniques for addressing cancer pain, and uses community health workers and pain care managers to coach patients through a personalized pain management plan. This study may help researchers learn how pain management strategies can improve cancer pain and lower risk of opioid exposure and dependency in cancer survivors.
NOTE: Although Mayo Clinic in Arizona, Mayo Clinic in Florida, and Mayo Clinic in Rochester are the main study locations, this study is also recruiting (enrolling remotely) at the following Mayo Clinic Health System locations. The study is virtual/remote, so no travel is required.
Mayo Clinic Health Systems-Mankato Mankato, MN 56001, US
Mayo Clinic Health System in Albert Lea Albert Lea, MN 56007, US
Mayo Clinic Health System in Austin Austin, MN 55912, US
Mayo Clinic Health System-Eau Claire Clinic Eau Claire, WI 54701, US
Mayo Clinic Health System-Franciscan Healthcare La Crosse, WI 54601, US
PRIMARY OBJECTIVE:
I. To test a validated collaborative care model-based intervention aimed at improving pain control among cancer survivors by promoting multimodal pain care (MMPC) to reduce inappropriate opioid use and by addressing social determinants of health (SDOH) that impede a patient's access to appropriate care.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive enhanced usual care, which includes access to the educational and pain self-management materials developed for the ASCENT trial (the ASCENT guide).
ARM II: Patients receive the ASCENT guide and attend 3 video or phone calls over 30 minutes each with their community health worker (CHW) and/or pain care manager (PCM). During the first call, patients discuss barriers to receiving help for their pain with their CHW. During the second call, patients work with their PCM to develop an action plan for addressing their pain using the different techniques and interventions detailed in the ASCENT guide. During the third and final call, patients meet with both their CHW and PCM to discuss specialist recommendations for their pain management plan. After the final visit, patients will be contacted by the CHW or PCM every other week to monitor their progress and may also be contacted as-needed based on the their reported pain intensity, symptoms, or reported barriers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (enhanced usual care) | Active Comparator | Patients receive enhanced usual care, which includes access to the educational and pain self-management materials developed for the ASCENT trial (the ASCENT guide). |
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| Arm II (ASCENT intervention) | Experimental | Patients receive the ASCENT guide and attend 3 video or phone calls over 30 minutes each with their CHW and/or PCM. During the first call, patients discuss barriers to receiving help for their pain with their CHW. During the second call, patients work with their PCM to develop an action plan for addressing their pain using the different techniques and interventions detailed in the ASCENT guide. During the third and final call, patients meet with both their CHW and PCM to discuss specialist recommendations for their pain management plan. After the final visit, patients will be contacted by the CHW or PCM every other week to monitor their progress and may also be contacted as-needed based on the their reported pain intensity, symptoms, or reported barriers. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive enhanced usual care |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Score | Will be measured using the Brief Pain Inventory Short Form (BPI SF), a 4-item questionnaire answered on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). A higher score indicates worse pain. | Baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical function | Will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form (SF) 6b, a 6-item questionnaire that measures the effects of pain on physical functioning over the past 7 days. Questions are answered on a scale of 1-5, with higher scores indicating more pain interference. | Baseline, 3 months, 6 months |
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Inclusion Criteria:
A qualifying liquid or solid cancer diagnosis with visits at a participating Mayo site in the past 15 years
Including malignant hematology
Age >= 18
Numeric Rating Scale (NRS) pain score of >= 5/10
Pain that developed or worsened following cancer diagnosis
Fit the description of either rural or Hispanic or both
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 507-293-1043 | mayocliniccancerstudies@mayo.edu | |
| Josiah Lulf | Contact | 507-538-7991 | Lulf.Josiah@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andrea L. Cheville, M.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Recruiting | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Patient Reported Outcome Measures will be administered at baseline by a study coordinator and at 3 and 6 months by a blinded, bilingual, assessor.
| Educational Intervention | Other | Receive ASCENT guide |
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| Questionnaire Administration | Other | Ancillary studies |
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| Electronic Health Record Review | Other | Ancillary studies |
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| Health Telemonitoring | Procedure | Attend video or phone calls with a CHW and/or PCM |
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| Cancer Pain Management | Behavioral | Receive personalized pain management plan |
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| Perceived Quality of Life | Will be measured using the European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L) questionnaire, which measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each component has three response levels of severity: no problems, some problems, extreme problems. | Baseline, 3 months, 6 months |
| Depression | Will be measured using the Patient Health Questionnaire-2 (PHQ-2), a two-item questionnaire answered with responses from 0 (not al all) to 3 (nearly every day). A higher score indicates a higher level of depression. | Baseline, 3 months, 6 months |
| Anxiety | Will be measured using the Generalized Anxiety Disorder-2 (GAD-2) scale, a two-item questionnaire answered with a score of 0 (not at all) to 3 (nearly every day). A higher score indicates higher frequency of being bothered by anxiety. | Baseline, 3 months, 6 months |
| Sleep | Will be measured using the PROMIS Sleep Disturbance 6a, a 6-item questionnaire assessing sleep disturbance over the past 7 days. Each question is answered with a score of 1-5, with a higher score indicating greater sleep disturbance. | Baseline, 3 months, 6 months |
| Employment status | Employment status will be self-reported | Baseline, 3 months, 6 months |
| Adherence to behavioral multimodal pain care plan components | Will be measured using logged count data. | Baseline, 3 months, 6 months |
| Use of study electronic-tools | Will be measured in minutes/week that participants access available electronic tools. | Baseline, 3 months, 6 months |
| Social isolation | Will be measured using the PROMIS SF 4a, a six-item questionnaire with each question answered on a five-point scale from 1 (never) to 5 (very often). Higher scores indicate greater perceived social isolation. | Baseline, 3 months, 6 months |
| Opioid consumption | Will be measured in oral morphine equivalents and collected using electronic health record (EHR) prescriptions. | Up to 6 months |
| Health care utilization | Will be measured by reviewing the electronic health record (EHR) and administrative billing data for incidents of hospitalization and emergency department visits | Up to 6 months |
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224-9980 | United States |
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| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
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