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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Leukemia, Hematopoietic and Lymphoid System Neoplasm, Lymphoma, Malignant Solid Neoplasm, Multiple Myeloma

Intervention / Treatment
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* Procedure: Acupuncture Therapy
* Behavioral: Cancer Pain Management
* Behavioral: Cognitive Behavior Therapy
* Procedure: Discussion
* Other: Educational Intervention
* Other: Exercise
* Other: Interview
* Procedure: Massage Therapy
* Behavioral: Mindfulness Relaxation
* Procedure: Pain Therapy
* Other: Palliative Therapy
* Behavioral: Patient Navigation
* Other: Referral
* Procedure: Spiritual Therapy
* Procedure: Spiritual Care Referral
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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 Acute leukemias

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (Pain management)<br>See detailed description. | Procedure: Acupuncture Therapy<br>* Undergo acupuncture therapy<br>* Other names: Acupuncture;Behavioral: Cancer Pain Management<br>* Receive pain clinic referral<br>* Other names: management of cancer pain;Behavioral: Cognitive Behavior Therapy<br>* Undergo CBT<br>* Other names: CT;Other: Educational Intervention<br>* Receive self-guided pain management education materials<br>* Other names: Intervention, Educational;Other: Exercise<br>* Participate in exercise<br>* Other names: Exercise Type;Other: Interview<br>* Complete interview<br>Procedure: Massage Therapy<br>* Receive massage<br>* Other names: Massage;Behavioral: Mindfulness Relaxation<br>* Practice mindfulness<br>* Other names: Mindfulness-Based Stress Reduction;Procedure: Pain Therapy<br>* Receive pain treatment/medicine<br>* Other names: Pain, Pain Management;Other: Palliative Therapy<br>* Receive palliative care referral<br>* Other names: Symptoms Management;Behavioral: Patient Navigation<br>* Undergo visits with PCM and CHW for pain management<br>* Other names: Patient Navigator Program;Other: Referral<br>* Receive pain management referrals<br>* Other names: Referred;Procedure: Spiritual Therapy<br>* Receive spiritual support<br>Procedure: Spiritual Care Referral<br>* Receive spiritual care referral<br>Other: Survey Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (Interview)<br>ASCENT study interventionists complete an interview on study. | Other: Interview<br>* Complete interview<br>|
| Active Comparator: Group III (Focus group)<br>Medical oncology providers participate in a focus group on study. | Procedure: Discussion<br>* Participate in focus group<br>* Other names: Discuss;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |