A Collaborative Intervention for Improving Cancer Pain Management in Cancer Survivors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Best Practice

    Other intervention

    Receive enhanced usual care

  • Educational Intervention

    Other intervention

    Receive ASCENT guide

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Health Telemonitoring

    Procedure/Surgery

    Attend video or phone calls with a CHW and/or PCM

  • Cancer Pain Management

    Behavioral

    Receive personalized pain management plan

Treatment groups

660 Participants
are divided into 2 treatment groups
Group A: Arm I (enhanced usual care)Active comparator 4 interventions
Group B: Arm II (ASCENT intervention)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 3 months, 6 months

Secondary outcomes

1

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.

Time frame
Baseline, 3 months, 6 months
2

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.

Time frame
Baseline, 3 months, 6 months
3

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.

Time frame
Baseline, 3 months, 6 months
4

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.

Time frame
Baseline, 3 months, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator