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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06063603
• Other study ID #: ASCENT
• Secondary ID: NCI-2023-05223AS
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2023
• Est. completion date: May 25, 2026

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

OUTLINE: Participants are assigned to 1 of 3 groups.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: May 25, 2026
• Est. primary completion date: May 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Leukemia
• Hematopoietic and Lymphoid System Neoplasm
• Lymphoma
• Malignant Solid Neoplasm
• Multiple Myeloma
• Neoplasms

Intervention

Procedure:
• Acupuncture Therapy
Undergo acupuncture therapy

Behavioral:
• Cancer Pain Management
Receive pain clinic referral
• Cognitive Behavior Therapy
Undergo CBT

Procedure:
• Discussion
Participate in focus group

Other:
• Educational Intervention
Receive self-guided pain management education materials
• Exercise
Participate in exercise
• Interview
Complete interview

Procedure:
• Massage Therapy
Receive massage

Behavioral:
• Mindfulness Relaxation
Practice mindfulness

Procedure:
• Pain Therapy
Receive pain treatment/medicine

Other:
• Palliative Therapy
Receive palliative care referral

Behavioral:
• Patient Navigation
Undergo visits with PCM and CHW for pain management

Other:
• Referral
Receive pain management referrals

Procedure:
• Spiritual Therapy
Receive spiritual support
• Spiritual Care Referral
Receive spiritual care referral

Other:
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability and acceptability of recruitment message	Assessed by the proportion of patients calling the ASCENT 1-800 line to express interest	Up to 3 years
Primary	Usability and acceptability of the PCIG (Patient Global Impression of Change) Questionnaire recruitment component	Assessed by the proportion of participants who open and completed the PCIG Questionnaire, a 0-6 scale where 0 is very much improved and 6 is very much worse	Baseline; Up to 3 years
Primary	Usability and acceptability of the EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) recruitment component	Assessed by the proportion of participants who open and completed the EQ-5D-3L questionnaire. Page 1 of the EQ-5D-3L descriptive system is comprised of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are expressed in a 5-digit number that describes the patient's health state.Page 2 is a vertical visual analog (sliding) scale (VAS) with the opposite endpoints labeled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.	Baseline; Up to 3 years
Primary	Usability and acceptability of the PCS (Pain Catastrophizing Scale) recruitment component	Assessed by the proportion of participants who open and completed the PCS Questionnaire, which consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale where 0=Not at all; 1=to a Slight Degree; 2=To a Moderate Degree; 3=To a Great Deal; and 4=All the Time.	Baseline; Up to 3 years
Primary	Usability and acceptability of the Patient Health Questionnaire (PHQ-8) recruitment component	Assessed by the proportion of participants who open and completed the PHQ-8, a depression measure which consists of 8 questions, with each item scored on a 4-point scale: Not at all; Several days; More than half the days; Nearly every day.	Baseline; Up to 3 years
Primary	Usability and acceptability of the Generalized Anxiety Disorder-7 (GAD-7) Questionnaire recruitment component	Assessed by the proportion of participants who open and completed the GAD-7, an anxiety measure which consists of 7 questions, with each item scored on a 4-point scale: Not at all; Several days; More than half the days; Nearly every day.	Baseline; Up to 3 years
Primary	Usability and acceptability of the Pain Self Efficacy Questionnaire (PSEQ) recruitment component	Assessed by the proportion of participants who open and completed the PSEQ, a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. Each item is scored on a 0-6 scale where 0=Not at all confident and 6=Completely.	Baseline; Up to 3 years
Primary	Usability and acceptability of the Social Determinants of Health (SDOH) intake component	Assessed by the proportion of participants who provide complete Social Determinants of Health (SDOH) histories by answering a series of 6 questions related to homelessness, safety in the home, health, and mood.	Baseline; Up to 3 years
Primary	Usability and acceptability of the Pain NRS (Numerical Rating Scale) intake component	Assessed by the proportion of participants who complete the Pain NRS, a 0-10 scale where 0 is no pain and 10 is the worst pain imaginable	Baseline; Up to 3 years
Primary	Usability and acceptability of the Information Technology (IT) Assessment intake component	Assessed by the proportion of participants who complete the IT Assessment, which consists of 4 questions related to technology access and usage.	Up to 3 years
Primary	Usability and acceptability of the Tobacco, Alcohol, Prescription Medication, and Other Substance use (TAPS) intake component	Assessed by the proportion of participants who complete the TAPS-1 Questionnaire, the tool's first-stage screening component, which consists of five questions related to usage of four substance categories (tobacco, alcohol, prescriptions, or other substances) in the past 12 months. Response option are 0-Daily or Almost Daily, 1-Weekly, 2-Monthly, 3-Less Than Monthly, or 4-Never.	Up to 3 years
Primary	Usability and acceptability of the ASCENT Conversation Guide intake component - intervention	Assessed by the proportion of participants who select a Tier 1 pain management intervention or request review of Tier 2 pain management options	Up to 3 years
Primary	Usability and acceptability of the ASCENT Conversation Guide intake component - engagement	Assessed on an 11-point numerical rating scales (NRS) by Pain Care Managers and/or Community Health Workers who are conducting intake interviews.	Up to 3 years
Primary	Usability and acceptability of planning visit recommendation component - revision	Assessed by the proportion of participants who request revisions to the recommended plan	Up to 3 years
Primary	Usability and acceptability of intake visit component - SMART Goal recommendation	Assessed by the proportion of participants who develop a SMART (Specific, Measurable, Achievable, Relevant, and Time-Bound) Goal	Up to 3 years
Primary	Usability and acceptability of planning visit component - SMART Goal completion	Assessed by the proportion of participants who complete a SMART (Specific, Measurable, Achievable, Relevant, and Time-Bound) Goal	Up to 3 years
Primary	Usability and acceptability of planning visit recommendation component - cancer pain intervention	Assessed by the category of pain intervention selected during the planning visit as the initial focus of a multi-modal pain care plan, either Tier 1 (Exercise, Cognitive Behavior Therapy [CBT], and Medicine) or Tier 2 (Integrative Medicine [Massage, Acupuncture, Mindfulness], Spiritual Support, Pain Clinic Referrals, and/or Palliative and Spiritual Care Referrals).	Up to 3 years
Primary	Usability and acceptability of final visit - cancer pain management component	Recorded as the category/ies of barriers impeding receipt of recommended pain care, as assessed by a brief survey	Up to 3 years
Primary	Usability and acceptability of follow-up visit - survey completion	Assessed by the proportion of participants completing surveys by administration mode (electronic health record portal, video visit, or phone interview, or printed questionnaire)	Up to 3 years
Primary	Usability and acceptability of follow-up visit - cancer pain management	Assessed by the proportion of participants completing surveys by administration mode, cause of pain escalation (categorical), and participant-perceived barriers (categorical).	Up to 3 years
Primary	Usability and acceptability of follow-up visit - barriers to pain care	Assessed by participant-reported categories of barriers impeding receipt of recommended pain care	Up to 3 years
Primary	Participant response rates	Overall participant response rates will be assessed according to the number of patient-reported outcome measure (PROM) assessments, recruitment questionnaires, and remote pain assessments completed.	Up to 3 years