Chronic LeukemiaNCT06063603
Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study
A study testing Acupuncture Therapy, Cancer Pain Management and Cognitive Behavior Therapy in people with Chronic Leukemia and Hematopoietic and Lymphoid System Neoplasm, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Leukemia, Hematopoietic and Lymphoid System Neoplasm, Lymphoma
- What is being tested?
- Acupuncture Therapy, Cancer Pain Management and Cognitive Behavior Therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 May 2023to 2 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Pilot Test of a Pain Management Intervention Preparatory to a Future Pragmatic Trial (ASCENT)
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.
Read the 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.
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.
- Conditions
- Chronic Leukemia, Hematopoietic and Lymphoid System Neoplasm, Lymphoma, Malignant Solid Neoplasm, Multiple Myeloma
- Being tested
- Acupuncture Therapy, Cancer Pain Management, Cognitive Behavior Therapy, Discussion, Educational Intervention
- Medical subject headings
- Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture TherapyProcedure or surgery
Also called Acupuncture
Undergo acupuncture therapy
Cancer Pain ManagementBehavioural
Also called management of cancer pain
Receive pain clinic referral
Cognitive Behavior TherapyBehavioural
Also called CBT, cognitive therapy, CT
Undergo CBT
DiscussionProcedure or surgery
Also called Discuss
Participate in focus group
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive self-guided pain management education materials
ExerciseOther
Also called Exercise Type
Participate in exercise
InterviewOther
Complete interview
Massage TherapyProcedure or surgery
Also called Massage
Receive massage
Mindfulness RelaxationBehavioural
Also called MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction
Practice mindfulness
Pain TherapyProcedure or surgery
Also called Analgesia, Pain Control, Pain Management, Pain, Pain Management
Receive pain treatment/medicine
Palliative TherapyOther
Also called Comfort Care, PA-Palliative Therapy, palliation, Palliative
Receive palliative care referral
Patient NavigationBehavioural
Also called Patient Navigator Program
Undergo visits with PCM and CHW for pain management
ReferralOther
Also called Referred
Receive pain management referrals
Spiritual TherapyProcedure or surgery
Receive spiritual support
Spiritual Care ReferralProcedure or surgery
Receive spiritual care referral
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (Pain management) | Experimental | See detailed description. Receives: Procedure: Acupuncture Therapy; Behavioral: Cancer Pain Management; Behavioral: Cognitive Behavior Therapy; 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 |
| Group II (Interview) | Active comparator | ASCENT study interventionists complete an interview on study. Receives: Other: Interview |
| Group III (Focus group) | Active comparator | Medical oncology providers participate in a focus group on study. Receives: Procedure: Discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention
Assessed by proportion of participants who received key intervention components.
Measured: Up to 60 days
Acceptability of Intervention - Interaction
As assessed by frequency of participant interaction with care team.
Measured: Up to 60 days
Acceptability of Intervention - Satisfaction
As assessed by participant satisfaction with care team interactions
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start22 May 2023
- Primary completion2 Feb 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic LeukemiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea L. Cheville, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063603
- Sponsor's protocol ID
- ASCENT_Pilot
- Other IDs
- NCI-2023-05223, ASCENT, 23-004139
- Status last verified
- Mar 2024
- First submitted
- 13 Sep 2023
- Last updated
- 18 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test of a Pain Management Intervention Preparatory to a Future Pragmatic Trial (ASCENT)
- ClinicalTrials.gov ID
- NCT06063603
- Acronym / sponsor ID
- ASCENT_Pilot
- Conditions
- Chronic Leukemia, Hematopoietic and Lymphoid System Neoplasm, Lymphoma, Malignant Solid Neoplasm, Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Posted 18 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (Pain management) | Experimental | Procedure: Acupuncture Therapy, Behavioral: Cancer Pain Management, Behavioral: Cognitive Behavior Therapy, 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 AdministrationSee detailed description. |
| Group II (Interview) | Active comparator | Other: InterviewASCENT study interventionists complete an interview on study. |
| Group III (Focus group) | Active comparator | Procedure: DiscussionMedical oncology providers participate in a focus group on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture TherapyAlso: AcupunctureUndergo acupuncture therapy | Procedure or surgery | Group I (Pain management) |
| Cancer Pain ManagementAlso: management of cancer painReceive pain clinic referral | Behavioural | Group I (Pain management) |
| Cognitive Behavior TherapyAlso: CBT, cognitive therapy, CTUndergo CBT | Behavioural | Group I (Pain management) |
| DiscussionAlso: DiscussParticipate in focus group | Procedure or surgery | Group III (Focus group) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive self-guided pain management education materials | Other | Group I (Pain management) |
| ExerciseAlso: Exercise TypeParticipate in exercise | Other | Group I (Pain management) |
| InterviewComplete interview | Other | Group I (Pain management), Group II (Interview) |
| Massage TherapyAlso: MassageReceive massage | Procedure or surgery | Group I (Pain management) |
| Mindfulness RelaxationAlso: MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress ReductionPractice mindfulness | Behavioural | Group I (Pain management) |
| Pain TherapyAlso: Analgesia, Pain Control, Pain Management, Pain, Pain ManagementReceive pain treatment/medicine | Procedure or surgery | Group I (Pain management) |
| Palliative TherapyAlso: Comfort Care, PA-Palliative Therapy, palliation, PalliativeReceive palliative care referral | Other | Group I (Pain management) |
| Patient NavigationAlso: Patient Navigator ProgramUndergo visits with PCM and CHW for pain management | Behavioural | Group I (Pain management) |
| ReferralAlso: ReferredReceive pain management referrals | Other | Group I (Pain management) |
| Spiritual TherapyReceive spiritual support | Procedure or surgery | Group I (Pain management) |
| Spiritual Care ReferralReceive spiritual care referral | Procedure or surgery | Group I (Pain management) |
| Survey AdministrationAncillary studies | Other | Group I (Pain management) |
Primary outcome
Feasibility of Intervention
Time frame: Up to 60 days
Assessed by proportion of participants who received key intervention components.
Acceptability of Intervention - Interaction
Time frame: Up to 60 days
As assessed by frequency of participant interaction with care team.
Acceptability of Intervention - Satisfaction
Time frame: Up to 60 days
As assessed by participant satisfaction with care team interactions
Utility of Intervention - Helpfulness
Time frame: Up to 60 days
Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all and 5 = extremely helpful.
Utility of Intervention - Confidence
Time frame: Up to 60 days
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.
Utility of Intervention - Ease
Time frame: Up to 60 days
Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = very difficult and 5 = extremely easy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea L. Cheville, M.D. principal investigator
Mayo Clinic in Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture Therapy, Cancer Pain Management and Cognitive Behavior Therapy in people with Chronic Leukemia and Hematopoietic and Lymphoid System Neoplasm, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention (time frame: Up to 60 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.