Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06198010

A Collaborative Intervention for Improving Cancer Pain Management in Cancer Survivors

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hematopoietic and Lymphoid System Neoplasm Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive enhanced usual care

Other names: standard of care, standard therapy

Educational Intervention

Other

Receive ASCENT guide

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Questionnaire Administration

Other

Ancillary studies

Electronic Health Record Review

Other

Ancillary studies

Health Telemonitoring

Procedure

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

Cancer Pain Management

Behavioral

Receive personalized pain management plan

Other names: management of cancer pain

Primary outcomes

  1. Change in Pain Score

    Time frame: 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 outcomes

  1. Physical function

    Time frame: 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.

  2. Perceived Quality of Life

    Time frame: 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.

  3. Depression

    Time frame: 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.

  4. Anxiety

    Time frame: 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.

  5. Sleep

    Time frame: 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.

  6. Employment status

    Time frame: Baseline, 3 months, 6 months

    Employment status will be self-reported

  7. Adherence to behavioral multimodal pain care plan components

    Time frame: Baseline, 3 months, 6 months

    Will be measured using logged count data.

  8. Use of study electronic-tools

    Time frame: Baseline, 3 months, 6 months

    Will be measured in minutes/week that participants access available electronic tools.

  9. Social isolation

    Time frame: 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.

  10. Opioid consumption

    Time frame: Up to 6 months

    Will be measured in oral morphine equivalents and collected using electronic health record (EHR) prescriptions.

  11. Health care utilization

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

507-293-1043

Josiah Lulf

CONTACT

[email protected]

507-538-7991

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Advancing Safe, Comprehensive, Digitally-Enabled Cancer Pain managemeNT (ASCENT)

Acronym: ASCENT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 10, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.