Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVE:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group I (Pain management) See detailed description. |
Procedure: Acupuncture Therapy
Undergo acupuncture therapy
Other Names:
Behavioral: Cancer Pain Management
Receive pain clinic referral
Other Names:
Behavioral: Cognitive Behavior Therapy
Undergo CBT
Other Names:
Other: Educational Intervention
Receive self-guided pain management education materials
Other Names:
Other: Exercise
Participate in exercise
Other Names:
Other: Interview
Complete interview
Procedure: Massage Therapy
Receive massage
Other Names:
Behavioral: Mindfulness Relaxation
Practice mindfulness
Other Names:
Procedure: Pain Therapy
Receive pain treatment/medicine
Other Names:
Other: Palliative Therapy
Receive palliative care referral
Other Names:
Behavioral: Patient Navigation
Undergo visits with PCM and CHW for pain management
Other Names:
Other: Referral
Receive pain management referrals
Other Names:
Procedure: Spiritual Therapy
Receive spiritual support
Procedure: Spiritual Care Referral
Receive spiritual care referral
Other: Survey Administration
Ancillary studies
|
| Active Comparator: Group II (Interview) ASCENT study interventionists complete an interview on study. |
Other: Interview
Complete interview
|
| Active Comparator: Group III (Focus group) Medical oncology providers participate in a focus group on study. |
Procedure: Discussion
Participate in focus group
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Usability and acceptability of recruitment message [Up to 3 years]
Assessed by the proportion of patients calling the ASCENT 1-800 line to express interest
- Usability and acceptability of the PCIG (Patient Global Impression of Change) Questionnaire recruitment component [Baseline; Up to 3 years]
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
- Usability and acceptability of the EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) recruitment component [Baseline; Up to 3 years]
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.
- Usability and acceptability of the PCS (Pain Catastrophizing Scale) recruitment component [Baseline; Up to 3 years]
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.
- Usability and acceptability of the Patient Health Questionnaire (PHQ-8) recruitment component [Baseline; Up to 3 years]
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.
- Usability and acceptability of the Generalized Anxiety Disorder-7 (GAD-7) Questionnaire recruitment component [Baseline; Up to 3 years]
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.
- Usability and acceptability of the Pain Self Efficacy Questionnaire (PSEQ) recruitment component [Baseline; Up to 3 years]
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.
- Usability and acceptability of the Social Determinants of Health (SDOH) intake component [Baseline; Up to 3 years]
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.
- Usability and acceptability of the Pain NRS (Numerical Rating Scale) intake component [Baseline; Up to 3 years]
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
- Usability and acceptability of the Information Technology (IT) Assessment intake component [Up to 3 years]
Assessed by the proportion of participants who complete the IT Assessment, which consists of 4 questions related to technology access and usage.
- Usability and acceptability of the Tobacco, Alcohol, Prescription Medication, and Other Substance use (TAPS) intake component [Up to 3 years]
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.
- Usability and acceptability of the ASCENT Conversation Guide intake component - intervention [Up to 3 years]
Assessed by the proportion of participants who select a Tier 1 pain management intervention or request review of Tier 2 pain management options
- Usability and acceptability of the ASCENT Conversation Guide intake component - engagement [Up to 3 years]
Assessed on an 11-point numerical rating scales (NRS) by Pain Care Managers and/or Community Health Workers who are conducting intake interviews.
- Usability and acceptability of planning visit recommendation component - revision [Up to 3 years]
Assessed by the proportion of participants who request revisions to the recommended plan
- Usability and acceptability of intake visit component - SMART Goal recommendation [Up to 3 years]
Assessed by the proportion of participants who develop a SMART (Specific, Measurable, Achievable, Relevant, and Time-Bound) Goal
- Usability and acceptability of planning visit component - SMART Goal completion [Up to 3 years]
Assessed by the proportion of participants who complete a SMART (Specific, Measurable, Achievable, Relevant, and Time-Bound) Goal
- Usability and acceptability of planning visit recommendation component - cancer pain intervention [Up to 3 years]
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).
- Usability and acceptability of final visit - cancer pain management component [Up to 3 years]
Recorded as the category/ies of barriers impeding receipt of recommended pain care, as assessed by a brief survey
- Usability and acceptability of follow-up visit - survey completion [Up to 3 years]
Assessed by the proportion of participants completing surveys by administration mode (electronic health record portal, video visit, or phone interview, or printed questionnaire)
- Usability and acceptability of follow-up visit - cancer pain management [Up to 3 years]
Assessed by the proportion of participants completing surveys by administration mode, cause of pain escalation (categorical), and participant-perceived barriers (categorical).
- Usability and acceptability of follow-up visit - barriers to pain care [Up to 3 years]
Assessed by participant-reported categories of barriers impeding receipt of recommended pain care
- Participant response rates [Up to 3 years]
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.
Eligibility Criteria
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
-
Acute leukemias
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Arizona | Scottsdale | Arizona | United States | 85259 |
| 2 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Andrea L. Cheville, M.D., Mayo Clinic in Rochester
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- ASCENT
- NCI-2023-05223
- ASCENT
- 23-004139