Neoplasms

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Symptoms and General Pathology

Rare Diseases

Lymphoma

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ASCENT study interventionists complete an interview on study.

Medical oncology providers participate in a focus group on study.

Acupuncture Therapy

Cancer Pain Management

Cognitive Behavior Therapy

Discussion

Receive self-guided pain management education materials

Educational Intervention

Exercise

Interview

Massage Therapy

Mindfulness Relaxation

Pain Therapy

Palliative Therapy

Undergo visits with PCM and CHW for pain management

Patient Navigation

Referral

Spiritual Therapy

Spiritual Care Referral

Survey Administration

Clinical Trials Referral Office

Donald W. Northfelt, M.D.

Andrea L. Cheville, M.D.

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.

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.

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

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

Assessed by the proportion of patients calling the ASCENT 1-800 line to express interest

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

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.

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.

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.

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.

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.

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.

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

Assessed by the proportion of participants who complete the IT Assessment, which consists of 4 questions related to technology access and usage.

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.

Assessed by the proportion of participants who select a Tier 1 pain management intervention or request review of Tier 2 pain management options

Assessed on an 11-point numerical rating scales (NRS) by Pain Care Managers and/or Community Health Workers who are conducting intake interviews.

Assessed by the proportion of participants who request revisions to the recommended plan

Assessed by the proportion of participants who develop a SMART (Specific, Measurable, Achievable, Relevant, and Time-Bound) Goal

Assessed by the proportion of participants who complete a SMART (Specific, Measurable, Achievable, Relevant, and Time-Bound) Goal

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).

Recorded as the category/ies of barriers impeding receipt of recommended pain care, as assessed by a brief survey

Assessed by the proportion of participants completing surveys by administration mode (electronic health record portal, video visit, or phone interview, or printed questionnaire)

Assessed by the proportion of participants completing surveys by administration mode, cause of pain escalation (categorical), and participant-perceived barriers (categorical).

Assessed by participant-reported categories of barriers impeding receipt of recommended pain care

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study	NCT06063603	Chronic Leukemi... Hematopoietic a... Lymphoma Malignant Solid... Multiple Myelom...	Acupuncture The... Cancer Pain Man... Cognitive Behav... Discussion Educational Int... Exercise Interview Massage Therapy Mindfulness Rel... Pain Therapy Palliative Ther... Patient Navigat... Referral Spiritual Thera... Spiritual Care ... Survey Administ...	18 Years -	Mayo Clinic
Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study	NCT06063603	Chronic Leukemi... Hematopoietic a... Lymphoma Malignant Solid... Multiple Myelom...	Acupuncture The... Cancer Pain Man... Cognitive Behav... Discussion Educational Int... Exercise Interview Massage Therapy Mindfulness Rel... Pain Therapy Palliative Ther... Patient Navigat... Referral Spiritual Thera... Spiritual Care ... Survey Administ...	18 Years -	Mayo Clinic

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