A Collaborative Intervention for Improving Cancer Pain Management in Cancer Survivors

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Best Practice
  Receive enhanced usual care
• Другое Educational Intervention
  Receive ASCENT guide
• Другое Questionnaire Administration
  Ancillary studies
• Другое Electronic Health Record Review
  Ancillary studies
• Процедура Health Telemonitoring
  Attend video or phone calls with a CHW and/or PCM
• Поведенческое Cancer Pain Management
  Receive personalized pain management plan

Первичные конечные точки

• Change in Pain Score [Срок оценки: Baseline, 3 months, 6 months]

Вторичные конечные точки (11)

• Physical function [Срок оценки: Baseline, 3 months, 6 months]
• Perceived Quality of Life [Срок оценки: Baseline, 3 months, 6 months]
• Depression [Срок оценки: Baseline, 3 months, 6 months]
• Anxiety [Срок оценки: Baseline, 3 months, 6 months]
• Sleep [Срок оценки: Baseline, 3 months, 6 months]
• Employment status [Срок оценки: Baseline, 3 months, 6 months]
• Adherence to behavioral multimodal pain care plan components [Срок оценки: Baseline, 3 months, 6 months]
• Use of study electronic-tools [Срок оценки: Baseline, 3 months, 6 months]
• Social isolation [Срок оценки: Baseline, 3 months, 6 months]
• Opioid consumption [Срок оценки: Up to 6 months]
• Health care utilization [Срок оценки: Up to 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 3 центра

• Mayo Clinic in Arizona — Scottsdale
• Mayo Clinic in Florida — Jacksonville
• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT06198010 · ASCENT_MAIN · R33CA278594 · 23-010838

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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