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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-05223 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| ASCENT | Other Identifier | Mayo Clinic in Rochester | |
| 23-004139 | Other Identifier | Mayo Clinic Institutional Review Board |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Pain management) | Experimental | See detailed description. |
|
| Group II (Interview) | Active Comparator | ASCENT study interventionists complete an interview on study. |
|
| Group III (Focus group) | Active Comparator | Medical oncology providers participate in a focus group on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture Therapy | Procedure | Undergo acupuncture therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Intervention | Assessed by proportion of participants who received key intervention components. | Up to 60 days |
| Acceptability of Intervention - Interaction | As assessed by frequency of participant interaction with care team. | Up to 60 days |
| Acceptability of Intervention - Satisfaction | As assessed by participant satisfaction with care team interactions | Up to 60 days |
| Utility of Intervention - Helpfulness | Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all and 5 = extremely helpful. | Up to 60 days |
| Utility of Intervention - Confidence | Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all confident and 5 = extremely confident. | Up to 60 days |
| Utility of Intervention - Ease | Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = very difficult and 5 = extremely easy. | Up to 60 days |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea L. Cheville, M.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic in Rochester |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Only Group 1 were actual participants who were enrolled in the study and received the intervention. Data was only collected for Group 1, so this is the only data reported.
Group 2 consisted of interventionalists (provided the intervention to Group 1 participants). Group 3 were Medical Oncology providers. Neither Group 2 nor 3 received any intervention or were enrolled in the study. Groups 2 and 3 participated only in study development.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I (Pain Management) | See detailed description. Acupuncture Therapy: Undergo acupuncture therapy Cancer Pain Management: Receive pain clinic referral Cognitive Behavior Therapy(CBT): Undergo CBT Educational Intervention: Receive self-guided pain management education materials Exercise: Participate in exercise Interview: Complete interview Massage Therapy: Receive massage Mindfulness Relaxation: Practice mindfulness Pain Therapy: Receive pain treatment/medicine Palliative Therapy: Receive palliative care referral Patient Navigation: Undergo visits with pain care manager (PCM) and community health worker (CHW) for pain management Referral: Receive pain management referrals Spiritual Therapy: Receive spiritual support Spiritual Care Referral: Receive spiritual care referral Survey Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2023 |
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| Cancer Pain Management | Behavioral | Receive pain clinic referral |
|
|
| Cognitive Behavior Therapy | Behavioral | Undergo CBT |
|
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| Discussion | Procedure | Participate in focus group |
|
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| Educational Intervention | Other | Receive self-guided pain management education materials |
|
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| Exercise | Other | Participate in exercise |
|
|
| Interview | Other | Complete interview |
|
| Massage Therapy | Procedure | Receive massage |
|
|
| Mindfulness Relaxation | Behavioral | Practice mindfulness |
|
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| Pain Therapy | Procedure | Receive pain treatment/medicine |
|
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| Palliative Therapy | Other | Receive palliative care referral |
|
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| Patient Navigation | Behavioral | Undergo visits with PCM and CHW for pain management |
|
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| Referral | Other | Receive pain management referrals |
|
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| Spiritual Therapy | Procedure | Receive spiritual support |
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| Spiritual Care Referral | Procedure | Receive spiritual care referral |
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| Survey Administration | Other | Ancillary studies |
|
| Rochester |
| Minnesota |
| 55905 |
| United States |
| FG001 | Group 2 (Intervention Providers) | Study interventionalists complete an interview on study. |
| FG002 | Group 3 (Medical Oncology Providers) | Medical oncology providers participate in a focus group on study. |
| Completed Intake Visit |
|
| Completed Planning Visit |
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| Completed Final Visit |
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| Completed Survey |
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| Participated in Focus Group |
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| Participated in Interventionalist's Interview |
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| COMPLETED |
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| NOT COMPLETED |
|
Groups II and III were not enrolled to the study. They participated in development and evaluation of this pilot as providers. These groups did not receive the study intervention, and no demographic or outcome data was collected from these groups. Only data from Group 1 is reported.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I (Pain Management) | See detailed description. Acupuncture Therapy: Undergo acupuncture therapy Cancer Pain Management: Receive pain clinic referral Cognitive Behavior Therapy: Undergo CBT Educational Intervention: Receive self-guided pain management education materials Exercise: Participate in exercise Interview: Complete interview Massage Therapy: Receive massage Mindfulness Relaxation: Practice mindfulness Pain Therapy: Receive pain treatment/medicine Palliative Therapy: Receive palliative care referral Patient Navigation: Undergo visits with PCM and CHW for pain management Referral: Receive pain management referrals Spiritual Therapy: Receive spiritual support Spiritual Care Referral: Receive spiritual care referral Survey Administration: Ancillary studies |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Rural-Urban Commuting Area (RUCA) category | Count of Participants | Participants |
| ||||||||||||||||||
| Cancer type | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Intervention | Assessed by proportion of participants who received key intervention components. | Participants who completed all three visits were sent a survey about their experience with the ASCENT pilot--of the 41 who completed all 3 visits, 35 completed the survey. | Posted | Count of Participants | Participants | Up to 60 days |
|
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| ||||||||||||||||||||||||||||
| Primary | Acceptability of Intervention - Interaction | As assessed by frequency of participant interaction with care team. | Posted | Count of Participants | Participants | Up to 60 days |
|
| ||||||||||||||||||||||||||||||
| Primary | Acceptability of Intervention - Satisfaction | As assessed by participant satisfaction with care team interactions | Posted | Count of Participants | Participants | Up to 60 days |
|
| ||||||||||||||||||||||||||||||
| Primary | Utility of Intervention - Helpfulness | Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all and 5 = extremely helpful. | Participants were asked about the helpfulness of specific components of the ASCENT intervention if and only if they utilized that component. | Posted | Count of Participants | Participants | Up to 60 days |
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| |||||||||||||||||||||||||||||
| Primary | Utility of Intervention - Confidence | Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all confident and 5 = extremely confident. | Five patients did not set goals and thus the question about setting goals with the care team was not applicable. | Posted | Count of Participants | Participants | Up to 60 days |
|
| |||||||||||||||||||||||||||||
| Primary | Utility of Intervention - Ease | Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = very difficult and 5 = extremely easy. | Participants were asked about the ease of use of specific components of the ASCENT intervention if and only if they utilized these components. Five participants did not utilize these components. | Posted | Count of Participants | Participants | Up to 60 days |
|
|
Up to 60 days
Groups II and III did not participate in the intervention and were not enrolled to the study. Adverse events were not collected from the provider and interventionalist participants in Group II or III.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I (Pain Management) | See detailed description. Acupuncture Therapy: Undergo acupuncture therapy Cancer Pain Management: Receive pain clinic referral Cognitive Behavior Therapy: Undergo CBT Educational Intervention: Receive self-guided pain management education materials Exercise: Participate in exercise Interview: Complete interview Massage Therapy: Receive massage Mindfulness Relaxation: Practice mindfulness Pain Therapy: Receive pain treatment/medicine Palliative Therapy: Receive palliative care referral Patient Navigation: Undergo visits with PCM and CHW for pain management Referral: Receive pain management referrals Spiritual Therapy: Receive spiritual support Spiritual Care Referral: Receive spiritual care referral Survey Administration: Ancillary studies | 0 | 51 | 0 | 51 | 0 | 51 |
| EG001 | Group II (Intervention Providers) | Group II participants were not enrolled to the study and participated only in study development. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Group III (Medical Oncology Providers) | Group III participants were not enrolled to the study and participated only in study development. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea L. Cheville, MD | Mayo Clinic | 507-284-2511 | cheville.andrea@mayo.edu |
| Jun 30, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D015928 | Cognitive Behavioral Therapy |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D015444 | Exercise |
| D005081 | Exercise Therapy |
| D007407 | Interviews as Topic |
| D008405 | Massage |
| D064866 | Mindfulness |
| D000099024 | Mindfulness-Based Stress Reduction |
| D000698 | Analgesia |
| D059408 | Pain Management |
| D010166 | Palliative Care |
| D000070659 | Patient Comfort |
| D062526 | Patient Navigation |
| D012017 | Referral and Consultation |
| D026443 | Spiritual Therapies |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D026741 | Physical Therapy Modalities |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000760 | Anesthesia and Analgesia |
| D019468 | Disease Management |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| Small rural (RUCA 7-9) |
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| Rural (RUCA 10) |
|
| GI |
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| GYN |
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| Genitourinary |
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| Head and neck |
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| Heme |
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| Lung |
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| Melanoma |
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| Other |
|
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| Utilized mailed materials that discussed pain management techniques |
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| Utilized ASCENT website |
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| Utilized follow-up phone calls with a member of the ASCENT team |
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| Utilized the Action Plan |
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| Very helpful |
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| Extremely helpful |
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| Very helpful |
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| Extremely helpful |
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| Very helpful |
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| Extremely helpful |
|
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| Very helpful |
|
| Extremely helpful |
|
| Very helpful |
|
| Extremely helpful |
|
| Very confident |
|
| Extremely confident |
|
| N/A |
|
| Very confident |
|
| Extremely confident |
|
| N/A |
|
|
| Somewhat easy |
|
| Very easy |
|
|
| Somewhat easy |
|
| Very easy |
|
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| Somewhat easy |
|
| Very easy |
|
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| Somewhat easy |
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| Very easy |
|