Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study
- Conditions
- Hematopoietic and Lymphoid System NeoplasmLymphomaMalignant Solid NeoplasmMultiple MyelomaChronic Leukemia
- Interventions
- Procedure: Acupuncture TherapyProcedure: DiscussionBehavioral: Cancer Pain ManagementBehavioral: Cognitive Behavior TherapyOther: Educational InterventionOther: ExerciseOther: InterviewProcedure: Massage TherapyBehavioral: Mindfulness RelaxationProcedure: Pain TherapyOther: Palliative TherapyBehavioral: Patient NavigationOther: ReferralProcedure: Spiritual TherapyProcedure: Spiritual Care ReferralOther: Survey Administration
- Registration Number
- NCT06063603
- Lead Sponsor
- Mayo Clinic
- 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.
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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group I (Pain management) Acupuncture Therapy See detailed description. Group I (Pain management) Cognitive Behavior Therapy See detailed description. Group I (Pain management) Interview See detailed description. Group I (Pain management) Massage Therapy See detailed description. Group III (Focus group) Discussion Medical oncology providers participate in a focus group on study. Group I (Pain management) Cancer Pain Management See detailed description. Group I (Pain management) Educational Intervention See detailed description. Group I (Pain management) Mindfulness Relaxation See detailed description. Group I (Pain management) Pain Therapy See detailed description. Group I (Pain management) Referral See detailed description. Group I (Pain management) Survey Administration See detailed description. Group II (Interview) Interview ASCENT study interventionists complete an interview on study. Group I (Pain management) Exercise See detailed description. Group I (Pain management) Palliative Therapy See detailed description. Group I (Pain management) Spiritual Therapy See detailed description. Group I (Pain management) Spiritual Care Referral See detailed description. Group I (Pain management) Patient Navigation See detailed description.
- Primary Outcome Measures
Name Time Method 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 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 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 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 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).
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.
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 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 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 - 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 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 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 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 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 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 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 - barriers to pain care Up to 3 years Assessed by participant-reported categories of barriers impeding receipt of recommended pain care
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 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States