NCT06063603 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2025-09-18

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Feasibility of Intervention

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outcome · POSTED

Acceptability of Intervention - Interaction

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outcome · POSTED

Acceptability of Intervention - Satisfaction

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outcome · POSTED

Utility of Intervention - Helpfulness

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outcome · POSTED

Utility of Intervention - Confidence

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outcome · POSTED

Utility of Intervention - Ease

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
See detailed description.
intervention Names
Procedure: Acupuncture Therapy
Behavioral: Cancer Pain Management
Behavioral: Cognitive Behavior Therapy
Other: Educational Intervention
Other: Exercise
Other: Interview
Procedure: Massage Therapy
Behavioral: Mindfulness Relaxation
Procedure: Pain Therapy
Other: Palliative Therapy
Behavioral: Patient Navigation
Other: Referral
label
Group I (Pain management)
type
EXPERIMENTAL
description
ASCENT study interventionists complete an interview on study.
intervention Names
Other: Interview
label
Group II (Interview)
type
ACTIVE_COMPARATOR
description
Medical oncology providers participate in a focus group on study.
intervention Names
Procedure: Discussion
label
Group III (Focus group)
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Group I (Pain management)
description
Undergo acupuncture therapy
name
Acupuncture Therapy
other Names
Acupuncture
type
PROCEDURE
arm Group Labels
Group I (Pain management)
description
Receive pain clinic referral
name
Cancer Pain Management
other Names
management of cancer pain
type
BEHAVIORAL
arm Group Labels
Group I (Pain management)
description
Undergo CBT
name
Cognitive Behavior Therapy
other Names
CBT
cognitive therapy
CT
type
BEHAVIORAL
arm Group Labels
Group III (Focus group)
description
Participate in focus group
name
Discussion
other Names
Discuss
type
PROCEDURE
arm Group Labels
Group I (Pain management)
description
Receive self-guided pain management education materials
name
Educational Intervention
other Names
Education for Intervention
Intervention by Education
Intervention through Education
Intervention, Educational
type
OTHER
arm Group Labels
Group I (Pain management)
description
Participate in exercise
name
Exercise
other Names
Exercise Type
type
OTHER
arm Group Labels
Group I (Pain management)
Group II (Interview)
description
Complete interview
name
Interview
type
OTHER
arm Group Labels
Group I (Pain management)
description
Receive massage
name
Massage Therapy
other Names
Massage
type
PROCEDURE
arm Group Labels
Group I (Pain management)
description
Practice mindfulness
name
Mindfulness Relaxation
other Names
MBSR
Mindful Meditation
Mindfulness Meditation
Mindfulness-Based Stress Reduction
type
BEHAVIORAL
arm Group Labels
Group I (Pain management)
description
Receive pain treatment/medicine
name
Pain Therapy
other Names
Analgesia
Pain Control
Pain Management
Pain, Pain Management
type
PROCEDURE
arm Group Labels
Group I (Pain management)
description
Receive palliative care referral
name
Palliative Therapy
other Names
Comfort Care
PA-Palliative Therapy
palliation
Palliative
Palliative Care
Palliative Treatment
Symptom Management
Symptoms Management
type
OTHER
arm Group Labels
Group I (Pain management)
description
Undergo visits with PCM and CHW for pain management
name
Patient Navigation
other Names
Patient Navigator Program
type
BEHAVIORAL

Study design

allocation

NON_RANDOMIZED

intervention Model

SEQUENTIAL

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 51
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Assessed by proportion of participants who received key intervention components.
measure
Feasibility of Intervention
time Frame
Up to 60 days
description
As assessed by frequency of participant interaction with care team.
measure
Acceptability of Intervention - Interaction
time Frame
Up to 60 days
description
As assessed by participant satisfaction with care team interactions
measure
Acceptability of Intervention - Satisfaction
time Frame
Up to 60 days
description
Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all and 5 = extremely helpful.
measure
Utility of Intervention - Helpfulness
time Frame
Up to 60 days
description
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.
measure
Utility of Intervention - Confidence
time Frame
Up to 60 days
description
Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = very difficult and 5 = extremely easy.
measure
Utility of Intervention - Ease
time Frame
Up to 60 days

Full study description

brief Summary: 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.
detailed Description: 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.

Source references