About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A qualifying liquid or solid cancer diagnosis with visits at a participating Mayo site in the past 15 years
Including malignant hematology
Lymphoma
Myeloma
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Best Practice
Other interventionReceive enhanced usual care
Educational Intervention
Other interventionReceive ASCENT guide
Questionnaire Administration
Other interventionAncillary studies
Electronic Health Record Review
Other interventionAncillary studies
Health Telemonitoring
Procedure/SurgeryAttend video or phone calls with a CHW and/or PCM
Cancer Pain Management
BehavioralReceive personalized pain management plan
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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Mayo Clinic
Lead sponsor
National Cancer Institute (NCI)
Collaborator