Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERBest Practice
Receive enhanced usual care
OTHEREducational Intervention
Receive ASCENT guide
OTHERQuestionnaire Administration
Ancillary studies
OTHERElectronic Health Record Review
Ancillary studies
PROCEDUREHealth Telemonitoring
Attend video or phone calls with a CHW and/or PCM
BEHAVIORALCancer Pain Management
Receive personalized pain management plan
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Patient Reported Outcome Measures will be administered at baseline by a study coordinator and at 3 and 6 months by a blinded, bilingual, assessor.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A qualifying liquid or solid cancer diagnosis with visits at a participating Mayo site in the past 15 years * Including malignant hematology * Lymphoma * Myeloma * Chronic leukemias * 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
* Patient Health Questionnaire - 8 (PHQ8) score of \>= 13 * Hospice enrollment * Skilled nursing facility, inpatient rehabilitation facility, or long-term care placement * Encounters with Palliative Care or the Pain Clinic in the past two months or upcoming two months * Any mention of hospice referral in medical oncology encounter notes (assess through textual search of the Mayo Data Explorer) * Affirmative response to, Are you usually confined to a bed or chair more than a third of your waking hours because of your health? * Currently homeless * Do not feel safe in their home * New or worsening chest pain, chest tightness, or chest pressure * Back pain that is associated with a new or worsening weakness, control of bowels/bladder, or difficulty walking * Lightheadedness, inability to keep down food or fluids, or vomiting blood or dark coffee-grounds-like material * New or worsening headaches that are associated with vision changes, nausea, balance issues, or problems with speech * Screens positive for use of non-cannabis drug use a a frequency of monthly or greater * Inability to engage with the intervention due to medical or psychological response
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score | Baseline, 3 months, 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Quality of Life | Baseline, 3 months, 6 months | 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. |
| Depression | Baseline, 3 months, 6 months | 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. |
| Anxiety | Baseline, 3 months, 6 months | 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. |
| Sleep | Baseline, 3 months, 6 months | 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. |
| Employment status | Baseline, 3 months, 6 months | Employment status will be self-reported |
| Physical function | Baseline, 3 months, 6 months | 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. |
| Use of study electronic-tools | Baseline, 3 months, 6 months | Will be measured in minutes/week that participants access available electronic tools. |
| Social isolation | Baseline, 3 months, 6 months | 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. |
| Opioid consumption | Up to 6 months | Will be measured in oral morphine equivalents and collected using electronic health record (EHR) prescriptions. |
| Health care utilization | Up to 6 months | Will be measured by reviewing the electronic health record (EHR) and administrative billing data for incidents of hospitalization and emergency department visits |
| Adherence to behavioral multimodal pain care plan components | Baseline, 3 months, 6 months | Will be measured using logged count data. |
Countries
United States
Contacts
Primary ContactClinical Trials Referral Office
Backup ContactJosiah Lulf
Outcome results
None listed