Hematopoietic and Lymphoid System NeoplasmASCENTNCT06198010
A Collaborative Intervention for Improving Cancer Pain Management in Cancer Survivors
A study testing Best Practice, Educational Intervention and Questionnaire Administration in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 2 sites in United States.
Trial summary
This clinical trial tests a collaborative pain management intervention (ASCENT) for improving cancer pain in cancer survivors. Cancer pain is prevalent, under-treated, and remains a major cause of suffering, impairment, and disability for millions of Americans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
- What is being tested?
- Best Practice, Educational Intervention and Questionnaire Administration
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Feb 2024to 12 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 in the past 15 years
- Including malignant hematology
- Lymphoma
- Myeloma
- Chronic leukemias
- Age >= 18
Show all 9Show fewer
- Numeric Rating Scale (NRS) pain score of >= 5/10
- Pain that developed or worsened following cancer diagnosis
- Fit the description of either rural or Hispanic or both
Who cannot join
- Patient Health Questionnaire - 8 (PHQ8) score of >= 13
- Hospice enrollment
- Skilled nursing facility, inpatient rehabilitation facility, or long-term care placement
- Encounters with Palliative Care or the Pain Clinic in the past two months or upcoming two months
- Any mention of hospice referral in medical oncology encounter notes (assess through textual search of the Mayo Data Explorer)
- Affirmative response to, "Are you usually confined to a bed or chair more than a third of your waking hours because of your health?"
Show all 14Show fewer
- Currently homeless
- Do not feel safe in their home
- New or worsening chest pain, chest tightness, or chest pressure
- Back pain that is associated with a new or worsening weakness, control of bowels/bladder, or difficulty walking
- Lightheadedness, inability to keep down food or fluids, or vomiting blood or dark coffee-grounds-like material
- New or worsening headaches that are associated with vision changes, nausea, balance issues, or problems with speech
- Screens positive for use of non-cannabis drug use a a frequency of monthly or greater
- Inability to engage with the intervention due to medical or psychological response
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: Advancing Safe, Comprehensive, Digitally-Enabled Cancer Pain managemeNT (ASCENT) - Main Trial
This clinical trial tests a collaborative pain management intervention (ASCENT) for improving cancer pain in cancer survivors. 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. All cancer survivors stand to benefit from electronic health record innovations, as they can experience profound pain outcomes, including marked under- and over-prescribing of opioids. Digitally facilitated solutions are especially helpful and can be customized to address patient needs. The ASCENT intervention provides patients with an educational guide that describes techniques for addressing cancer pain, and uses community health workers and pain care managers to coach patients through a personalized pain management plan. This study may help researchers learn how pain management strategies can improve cancer pain and lower risk of opioid exposure and dependency in cancer survivors.
Read the detailed description
NOTE: Although Mayo Clinic in Arizona, Mayo Clinic in Florida, and Mayo Clinic in Rochester are the main study locations, this study is also recruiting (enrolling remotely) at the following Mayo Clinic Health System locations. The study is virtual/remote, so no travel is required.
Mayo Clinic Health Systems-Mankato Mankato, MN 56001, US
Mayo Clinic Health System in Albert Lea Albert Lea, MN 56007, US
Mayo Clinic Health System in Austin Austin, MN 55912, US
Mayo Clinic Health System-Eau Claire Clinic Eau Claire, WI 54701, US
Mayo Clinic Health System-Franciscan Healthcare La Crosse, WI 54601, US
PRIMARY OBJECTIVE:
- To test a validated collaborative care model-based intervention aimed at improving pain control among cancer survivors by promoting multimodal pain care (MMPC) to reduce inappropriate opioid use and by addressing social determinants of health (SDOH) that impede a patient's access to appropriate care.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive enhanced usual care, which includes access to the educational and pain self-management materials developed for the ASCENT trial (the ASCENT guide).
ARM II: Patients receive the ASCENT guide and attend 3 video or phone calls over 30 minutes each with their community health worker (CHW) and/or pain care manager (PCM). During the first call, patients discuss barriers to receiving help for their pain with their CHW. During the second call, patients work with their PCM to develop an action plan for addressing their pain using the different techniques and interventions detailed in the ASCENT guide. During the third and final call, patients meet with both their CHW and PCM to discuss specialist recommendations for their pain management plan. After the final visit, patients will be contacted by the CHW or PCM every other week to monitor their progress and may also be contacted as-needed based on the their reported pain intensity, symptoms, or reported barriers.
- Conditions
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
- Being tested
- Best Practice, Educational Intervention, Questionnaire Administration, Electronic Health Record Review, Health Telemonitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive enhanced usual care
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive ASCENT guide
Questionnaire AdministrationOther
Ancillary studies
Electronic Health Record ReviewOther
Ancillary studies
Health TelemonitoringProcedure or surgery
Attend video or phone calls with a CHW and/or PCM
Cancer Pain ManagementBehavioural
Also called management of cancer pain
Receive personalized pain management plan
| Study group | Role | What they receive |
|---|---|---|
| Arm I (enhanced usual care) | Active comparator | Patients receive enhanced usual care, which includes access to the educational and pain self-management materials developed for the ASCENT trial (the ASCENT guide). Receives: Other: Best Practice; Other: Educational Intervention; Other: Questionnaire Administration; Other: Electronic Health Record Review |
| Arm II (ASCENT intervention) | Experimental | Patients receive the ASCENT guide and attend 3 video or phone calls over 30 minutes each with their CHW and/or PCM. During the first call, patients discuss barriers to receiving help for their pain with their CHW. During the second call, patients work with their PCM to develop an action plan for addressing their pain using the different techniques and interventions detailed in the ASCENT guide. During the third and final call, patients meet with both their CHW and PCM to discuss specialist recommendations for their pain management plan. After the final visit, patients will be contacted by the CHW or PCM every other week to monitor their progress and may also be contacted as-needed based on the their reported pain intensity, symptoms, or reported barriers. Receives: Other: Best Practice; Other: Educational Intervention; Other: Questionnaire Administration; Other: Electronic Health Record Review; Procedure: Health Telemonitoring; Behavioral: Cancer Pain Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Score
Will be measured using the Brief Pain Inventory Short Form (BPI SF), a 4-item questionnaire answered on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). A higher score indicates worse pain.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (9)
Physical function
Will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form (SF) 6b, a 6-item questionnaire that measures the effects of pain on physical functioning over the past 7 days. Questions are answered on a scale of 1-5, with higher scores indicating more pain interference.
Measured: Baseline, 3 months, 6 months
Perceived Quality of Life
Will be measured using the European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L) questionnaire, which measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each component has three response levels of severity: no problems, some problems, extreme problems.
Measured: Baseline, 3 months, 6 months
Depression
Will be measured using the Patient Health Questionnaire-8 (PHQ-8), which consists of eight items each rated on a scale of 0 (not al all) to 3 (nearly every day). Higher scores indicate greater severity of depressive symptoms.
Measured: Baseline, 3 months, 6 months
Sleep
Will be measured using the PROMIS Sleep Disturbance 6a, a 6-item questionnaire assessing sleep disturbance over the past 7 days. Each question is answered with a score of 1-5, with a higher score indicating greater sleep disturbance.
Measured: Baseline, 3 months, 6 months
Employment status
Employment status will be self-reported
Measured: Baseline, 3 months, 6 months
Adherence to behavioral multimodal pain care plan components
Will be measured using logged count data.
Measured: Baseline, 3 months, 6 months
Use of study electronic-tools
Will be measured in minutes/week that participants access available electronic tools.
Measured: Baseline, 3 months, 6 months
Social isolation
Will be measured using the PROMIS SF 4a, a six-item questionnaire with each question answered on a five-point scale from 1 (never) to 5 (very often). Higher scores indicate greater perceived social isolation.
Measured: Baseline, 3 months, 6 months
Health care utilization
Will be measured by reviewing the electronic health record (EHR) and administrative billing data for incidents of hospitalization and emergency department visits
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start7 Feb 2024
- Primary completion12 Mar 2027 (estimated)
- Study completion12 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Andrea L. Cheville, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198010
- Sponsor's protocol ID
- ASCENT_MAIN
- Other IDs
- R33CA278594, 23-010838
- Acronym
- ASCENT
- Status last verified
- Oct 2026
- First submitted
- 27 Dec 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Safe, Comprehensive, Digitally-Enabled Cancer Pain managemeNT (ASCENT) - Main Trial
- ClinicalTrials.gov ID
- NCT06198010
- Acronym / sponsor ID
- ASCENT / ASCENT_MAIN
- Conditions
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 680 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 12 Mar 2027 (estimated)
- Study completion
- 12 Mar 2027 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
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 a collaborative pain management intervention (ASCENT) for improving cancer pain in cancer survivors. 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. All cancer survivors stand to benefit from electronic health record innovations, as they can experience profound pain outcomes, including marked under- and over-prescribing of opioids. Digitally facilitated solutions are especially helpful and can be customized to address patient needs. The ASCENT intervention provides patients with an educational guide that describes techniques for addressing cancer pain, and uses community health workers and pain care managers to coach patients through a personalized pain management plan. This study may help researchers learn how pain management strategies can improve cancer pain and lower risk of opioid exposure and dependency in cancer survivors.
Detailed description
NOTE: Although Mayo Clinic in Arizona, Mayo Clinic in Florida, and Mayo Clinic in Rochester are the main study locations, this study is also recruiting (enrolling remotely) at the following Mayo Clinic Health System locations. The study is virtual/remote, so no travel is required.
Mayo Clinic Health Systems-Mankato Mankato, MN 56001, US
Mayo Clinic Health System in Albert Lea Albert Lea, MN 56007, US
Mayo Clinic Health System in Austin Austin, MN 55912, US
Mayo Clinic Health System-Eau Claire Clinic Eau Claire, WI 54701, US
Mayo Clinic Health System-Franciscan Healthcare La Crosse, WI 54601, US
PRIMARY OBJECTIVE:
- To test a validated collaborative care model-based intervention aimed at improving pain control among cancer survivors by promoting multimodal pain care (MMPC) to reduce inappropriate opioid use and by addressing social determinants of health (SDOH) that impede a patient's access to appropriate care.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive enhanced usual care, which includes access to the educational and pain self-management materials developed for the ASCENT trial (the ASCENT guide).
ARM II: Patients receive the ASCENT guide and attend 3 video or phone calls over 30 minutes each with their community health worker (CHW) and/or pain care manager (PCM). During the first call, patients discuss barriers to receiving help for their pain with their CHW. During the second call, patients work with their PCM to develop an action plan for addressing their pain using the different techniques and interventions detailed in the ASCENT guide. During the third and final call, patients meet with both their CHW and PCM to discuss specialist recommendations for their pain management plan. After the final visit, patients will be contacted by the CHW or PCM every other week to monitor their progress and may also be contacted as-needed based on the their reported pain intensity, symptoms, or reported barriers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (enhanced usual care) | Active comparator | Other: Best Practice, Other: Educational Intervention, Other: Questionnaire Administration, Other: Electronic Health Record ReviewPatients receive enhanced usual care, which includes access to the educational and pain self-management materials developed for the ASCENT trial (the ASCENT guide). |
| Arm II (ASCENT intervention) | Experimental | Other: Best Practice, Other: Educational Intervention, Other: Questionnaire Administration, Other: Electronic Health Record Review, Procedure: Health Telemonitoring, Behavioral: Cancer Pain ManagementPatients receive the ASCENT guide and attend 3 video or phone calls over 30 minutes each with their CHW and/or PCM. During the first call, patients discuss barriers to receiving help for their pain with their CHW. During the second call, patients work with their PCM to develop an action plan for addressing their pain using the different techniques and interventions detailed in the ASCENT guide. During the third and final call, patients meet with both their CHW and PCM to discuss specialist recommendations for their pain management plan. After the final visit, patients will be contacted by the CHW or PCM every other week to monitor their progress and may also be contacted as-needed based on the their reported pain intensity, symptoms, or reported barriers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A qualifying liquid or solid cancer diagnosis with visits at a participating Mayo site in the past 15 years
- Age >= 18
- Numeric Rating Scale (NRS) pain score of >= 5/10
- Pain that developed or worsened following cancer diagnosis
- Fit the description of either rural or Hispanic or both
Key exclusion criteria (14 listed)
- Patient Health Questionnaire - 8 (PHQ8) score of >= 13
- Hospice enrollment
- Skilled nursing facility, inpatient rehabilitation facility, or long-term care placement
- Encounters with Palliative Care or the Pain Clinic in the past two months or upcoming two months
- Any mention of hospice referral in medical oncology encounter notes (assess through textual search of the Mayo Data Explorer)
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive enhanced usual care | Other | Arm I (enhanced usual care), Arm II (ASCENT intervention) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive ASCENT guide | Other | Arm I (enhanced usual care), Arm II (ASCENT intervention) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (enhanced usual care), Arm II (ASCENT intervention) |
| Electronic Health Record ReviewAncillary studies | Other | Arm I (enhanced usual care), Arm II (ASCENT intervention) |
| Health TelemonitoringAttend video or phone calls with a CHW and/or PCM | Procedure or surgery | Arm II (ASCENT intervention) |
| Cancer Pain ManagementAlso: management of cancer painReceive personalized pain management plan | Behavioural | Arm II (ASCENT intervention) |
Primary outcome
Change in Pain Score
Time frame: Baseline, 3 months, 6 months
Will be measured using the Brief Pain Inventory Short Form (BPI SF), a 4-item questionnaire answered on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). A higher score indicates worse pain.
9 secondary outcomes
Physical function
Time frame: Baseline, 3 months, 6 months
Perceived Quality of Life
Time frame: Baseline, 3 months, 6 months
Depression
Time frame: Baseline, 3 months, 6 months
Sleep
Time frame: Baseline, 3 months, 6 months
Employment status
Time frame: Baseline, 3 months, 6 months
Adherence to behavioral multimodal pain care plan components
Time frame: Baseline, 3 months, 6 months
Use of study electronic-tools
Time frame: Baseline, 3 months, 6 months
Social isolation
Time frame: Baseline, 3 months, 6 months
Health care utilization
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- 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 Best Practice, Educational Intervention and Questionnaire Administration in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid 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 9 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Pain Score (time frame: Baseline, 3 months, 6 months). 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 29 Oct 2026.