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NCT Number: NCT06063603

Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study

This clinical trial tests how well a pain management intervention preparatory to a future pragmatic trial works in rural dwelling and Hispanic cancer survivors. Cancer pain is a key case study in health disparities in the United States. 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. Hispanic and rural-dwelling cancer survivors stand to benefit the most from electronic health record innovations, as each of these health disparities populations experience profound disparities in pain outcomes, including marked under- and over-prescribing of opioids. Additionally, Hispanics not only comprise a steadily growing proportion of cancer survivors, but are also increasingly immigrating to rural communities, potentially placing them at "double risk" for poor outcomes. This trial will allow for the refinement of pain management intervention components that could help the management of cancer-related pain in rural dwelling and Hispanic cancer survivors.

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Key information

Conditions

Chronic Leukemia Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hematopoietic and Lymphoid System Neoplasm Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Malignant Solid Neoplasm Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

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

PRIMARY OBJECTIVE:

I. To refine and pilot test components of a validated collaborative care model-based intervention aimed at improving pain control among rural dwelling and Hispanic cancer survivors.

GROUP I: Participants meet with pain care manager (PCM) and community health worker (CHW) via telephone or video visit to discuss the cancer-related pain. Participants receive self-guided pain management education materials and receive an action plan with suggestions or referrals to participate in tier 1 interventions that include exercise, cognitive behavioral therapy, medication and/or tier 2 interventions that include integrative medicine (massage, acupuncture and mindfulness relaxation), spiritual support, pain clinic referral and palliative and spiritual care referrals during the intake visit. Participants undergo a planning visit 2 weeks later to give an update on their pain and may receive additional resources from the PCM and/or CHW. Participants then undergo a final visit 4 weeks later with the PCM and/or CHW and receive final recommendations and referrals. Participants may receive a follow up call between intake and visit 2 and/or between visit 2 and the final visit from the CHW or PCM to assess pain levels on study.

GROUP II: ASCENT study interventionists complete an interview on study.

GROUP III: Medical oncology providers participate in a focus group on study.

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
  • Age 18+
  • Numerical rating scale (NRS) pain score of a 5+ out of 10
  • Pain that developed (onset) or significantly worsened since cancer diagnosis
  • Malignant hematology including:
  • Lymphoma
  • Myeloma
  • Chronic leukemias

Exclusion criteria

  • Patient Health Questionnaire (PHQ) 8 score of 10 or more
  • Life expectancy less than 12 months
  • Hospice enrollment
  • Admitted to hospital from long term care/skilled nursing facilities (SNF)
  • Acute leukemias
  • Primary brain tumors
  • Confinement to a bed or a chair more than a third of waking hours because of health complications

Treatment and study plan

acupuncture therapy

Procedure

Undergo acupuncture therapy

Other names: Acupuncture

Cancer Pain Management

Behavioral

Receive pain clinic referral

Other names: management of cancer pain

Cognitive Behavior Therapy

Behavioral

Undergo CBT

Other names: CBT, cognitive therapy, CT

Discussion

Procedure

Participate in focus group

Other names: Discuss

Educational Intervention

Other

Receive self-guided pain management education materials

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

Exercise

Other

Participate in exercise

Other names: Exercise Type

interview

Other

Complete interview

Massage therapy

Procedure

Receive massage

Other names: Massage

Mindfulness Relaxation

Behavioral

Practice mindfulness

Other names: MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction

pain therapy

Procedure

Receive pain treatment/medicine

Other names: Analgesia, Pain Control, Pain Management, Pain, Pain Management

Palliative Therapy

Other

Receive palliative care referral

Other names: Comfort Care, PA-Palliative Therapy, palliation, Palliative, Palliative Care, Palliative Treatment, Symptom Management, Symptoms Management

Patient Navigation

Behavioral

Undergo visits with PCM and CHW for pain management

Other names: Patient Navigator Program

Referral

Other

Receive pain management referrals

Other names: Referred

Spiritual Therapy

Procedure

Receive spiritual support

Spiritual Care Referral

Procedure

Receive spiritual care referral

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Feasibility of Intervention

    Time frame: Up to 60 days

    Assessed by proportion of participants who received key intervention components.

  2. Acceptability of Intervention - Interaction

    Time frame: Up to 60 days

    As assessed by frequency of participant interaction with care team.

  3. Acceptability of Intervention - Satisfaction

    Time frame: Up to 60 days

    As assessed by participant satisfaction with care team interactions

  4. Utility of Intervention - Helpfulness

    Time frame: Up to 60 days

    Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all and 5 = extremely helpful.

  5. Utility of Intervention - Confidence

    Time frame: Up to 60 days

    Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all confident and 5 = extremely confident.

  6. Utility of Intervention - Ease

    Time frame: Up to 60 days

    Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = very difficult and 5 = extremely easy.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Pilot Test of a Pain Management Intervention Preparatory to a Future Pragmatic Trial (ASCENT)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 2, 2023
Registry last updated
Sep 18, 2025

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.

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