Pain Management for Cancer Survivors

(ASCENT Trial)

Recruiting at 2 trial locations

Overseen By Josiah Lulf

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Depression, Hospice, Homelessness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

660 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing pain in rural and Hispanic cancer survivors. It employs a program called ASCENT (Achieving Equity through SocioCulturally-informed, Digitally-Enabled Cancer Pain managemeNT), which includes an educational guide and support from community health workers and pain care managers. The researchers aim to determine if this approach can better address cancer pain and reduce the risk of opioid addiction. Individuals who have had cancer, experience pain since their diagnosis, and identify as rural or Hispanic may be eligible to participate. The trial will compare usual care with the ASCENT program to determine which is more effective. As an unphased trial, this study provides a unique opportunity to contribute to innovative pain management solutions tailored to specific communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the ASCENT intervention is safe for cancer survivors?

Research shows that the ASCENT program aims to manage cancer pain through personalized support and guidance. Community health workers and pain care managers assist patients in creating and following a pain management plan.

Although specific safety data for ASCENT is unavailable, similar programs have been used in other studies. These programs typically focus on non-drug methods and patient education, making them generally well-tolerated with few risks of side effects.

Since ASCENT does not introduce new medications but relies on educational and supportive techniques, it is expected to be safe for participants. The main goal is to reduce pain and improve quality of life without the side effects often associated with drugs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ASCENT intervention for pain management in cancer survivors because it offers a personalized, multi-step approach to care. Unlike standard pain management options, which typically involve medications like opioids or over-the-counter pain relievers, the ASCENT intervention emphasizes patient education and self-management. It includes personalized video or phone consultations with community health workers (CHWs) and primary care managers (PCMs) to identify barriers, create action plans, and incorporate specialist recommendations. This tailored, collaborative approach aims to empower patients, potentially leading to more effective and sustainable pain management.

What evidence suggests that the ASCENT intervention is effective for managing cancer pain in rural and Hispanic survivors?

Research has shown that the ASCENT program, a team-based plan for managing pain, can improve cancer pain management, particularly for rural and Hispanic cancer survivors. This trial will compare two approaches: Arm I, where participants receive enhanced usual care with access to educational and pain self-management materials developed for the ASCENT trial, and Arm II, where participants receive the ASCENT intervention, including personalized support through video or phone calls. Early results suggest that team collaboration and digital tools can improve outcomes and reduce pain. Previous studies on similar team-based approaches have demonstrated better clinical results and less reliance on opioids. This method holds promise for addressing disparities in pain management and providing personalized support to those who need it most. ^{1 3 4 6 7}

Who Is on the Research Team?

Andrea Cheville, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for rural and Hispanic cancer survivors experiencing pain from conditions like blood cancers and tumors. It's designed to help those who may struggle with managing their pain, including issues with opioid use. Participants should be comfortable using digital tools for health monitoring.

Inclusion Criteria

I have been diagnosed with a chronic leukemia.

Numeric Rating Scale (NRS) pain score of >= 5/10

My pain started or got worse after my cancer diagnosis.

Exclusion Criteria

I have been diagnosed with acute leukemia.

Currently homeless

I feel dizzy often, can't keep food down, or have vomited something that looks like coffee grounds.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ASCENT guide and attend 3 video or phone calls with their community health worker and/or pain care manager to develop and implement a personalized pain management plan.

6 months

3 initial calls (30 minutes each), followed by bi-weekly check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, with focus on pain management and opioid use.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• ASCENT

Trial Overview The ASCENT intervention being tested includes an educational guide on cancer pain management, personalized coaching by community health workers, and oversight by pain care managers. The study uses electronic records to tailor the approach to each patient's needs.

How Is the Trial Designed?

Group I: Arm II (ASCENT intervention) Experimental Treatment 6 Interventions

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.

Group II: Arm I (enhanced usual care) Active Control 4 Interventions

Patients receive enhanced usual care, which includes access to the educational and pain self-management materials developed for the ASCENT trial (the ASCENT guide).

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

American Indian cancer survivors often do not communicate about their pain and cancer experiences, which can lead to a lack of social support and reduced treatment compliance.

The study identified key barriers to communication, including cultural norms around discussing pain and death, and a strong respect for healthcare providers, highlighting the need for targeted educational interventions to improve symptom management and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

We Don't Talk about It: Cancer Pain and American Indian Survivors. Hodge, FS., Itty, TL., Samuel-Nakamura, C., et al.[2020]

The CAncer Pain management support Program showed positive effects on perceived isolation, personal resources, support care needs, and uncertainty among 94 Asian American breast cancer survivors, although it did not significantly reduce pain levels.

This pilot study highlights the importance of culturally tailored technology-based programs in addressing the unique support needs of ethnic minority cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Preliminary Efficacy of a Technology-Based Cancer Pain Management Program Among Asian American Breast Cancer Survivors. Chee, W., Lee, Y., Ji, X., et al.[2022]

In a study of 251 breast cancer survivors, Black patients were more likely to be prescribed opioids for longer than 90 days compared to White patients, indicating potential disparities in pain management practices.

Black breast cancer survivors reported worse symptoms and lower quality of life compared to their White counterparts, highlighting the need for further research to address these racial disparities in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Racial disparities in opioid prescription and pain management among breast cancer survivors. Kim, SJ., Retnam, RP., Sutton, AL., et al.[2023]

An educational intervention for cancer pain management significantly improved patient outcomes, with trained providers showing a notable reduction in patient pain levels over 4 months compared to untrained providers.

While the training led to better prescribing practices for co-analgesics, the effectiveness of the intervention diminished over time, highlighting the need for ongoing education to maintain improved pain management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An educational implementation of a cancer pain algorithm for ambulatory care. Du Pen, AR., Du Pen, S., Hansberry, J., et al.[2013]

A study involving 97 underserved African American and Hispanic cancer patients found that pain education did not significantly improve pain outcomes compared to a control group, indicating a need for more effective interventions.

Despite initial improvements in pain ratings for African American patients who received education, these benefits were not sustained over time, highlighting the limitations of brief educational interventions in managing cancer-related pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain education for underserved minority cancer patients: a randomized controlled trial. Anderson, KO., Mendoza, TR., Payne, R., et al.[2022]

Cancer survivors face significant barriers to accessing prescribed opioids due to restrictive policies, which can impact their pain management.

Concerns about addiction and side effects lead many cancer survivors to reduce their opioid use, and there is a lack of education on safe storage and disposal of these medications, highlighting a need for better support and resources from healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Framing Cancer Survivors' Access to and Use and Disposal of Prescribed Opioids Within the Opioid Epidemic. Marshall, VK., Chavez, MN., Rigg, KK., et al.[2023]

In a study of 64 older adults with cancer pain in hospice care, there were minimal differences in the implementation of pain management strategies between African American and Caucasian American patients, indicating overall comparable care.

However, African American patients had significantly lower assessments of primary pain characteristics and management of opioid-induced constipation, suggesting areas for improvement in pain management practices for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Racial Differences in Pain Management for Patients Receiving Hospice Care. Booker, SQ., Herr, KA., Wilson Garvan, C.[2022]

An online individualized education program significantly reduced patient-related barriers to cancer pain management in a study of 110 participants, indicating its effectiveness in improving patient understanding and coping strategies.

The program also led to a statistically significant reduction in pain intensity for certain pain categories, demonstrating that tailored education can enhance pain management outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of online pain management education on the patient related barriers to cancer pain management: A randomized controlled trial. Bilmiç, E., Selçukbiricik, F., Bagcivan, G.[2023]

A qualitative study involving 31 participants (18 advanced cancer patients and 13 caregivers) revealed that while most individuals recognized morphine as an effective pain reliever, they also associated it with end-stage illness and potential dependence, leading to hesitance in its use.

Despite concerns, participants expressed a willingness to use morphine for pain relief, highlighting the need for educational programs to address misconceptions about opioids, which could enhance acceptance and improve pain management in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morphine use for cancer pain: A strong analgesic used only at the end of life? A qualitative study on attitudes and perceptions of morphine in patients with advanced cancer and their caregivers. Ho, JFV., Yaakup, H., Low, GSH., et al.[2021]

A study involving 115 Asian American breast cancer survivors showed that a technology-based information and coaching program significantly reduced pain and accompanying symptoms over time, particularly in the intervention group.

The intervention group experienced greater decreases in physical symptom distress compared to the control group, indicating that technology-based support can effectively enhance pain management and improve quality of life for these survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of a technology-based information and coaching/support program on pain and symptoms in Asian American survivors of breast cancer. Im, EO., Kim, S., Yang, YL., et al.[2022]

Hispanic cancer patients often experience inadequate pain management due to a lack of communication with healthcare providers and traditional gender roles that discourage them from expressing their pain needs.

Cultural factors and the marginalized status of Hispanic patients in the U.S. healthcare system contribute to their challenges in describing and managing cancer pain, highlighting the need for more culturally sensitive approaches in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pain experience of Hispanic patients with cancer in the United States. Im, EO., Guevara, E., Chee, W.[2021]

An automated, telephone-based interactive voice response (IVR) intervention significantly reduced moderate to severe pain and improved other cancer-related symptoms in a pilot study involving 60 low-income African American and Latina women with breast cancer.

While the intervention showed effectiveness in managing pain and symptoms, oncologists rated its usefulness for symptom management as only somewhat beneficial, indicating a need for further research on technological approaches in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated pain intervention for underserved minority women with breast cancer. Anderson, KO., Palos, GR., Mendoza, TR., et al.[2022]

Cancer survivors need clear and comprehensive education about prescription opioid medications (POM) to ensure their safe use, especially in managing cancer-related pain.

There is a significant concern among cancer survivors regarding the risks of addiction to opioids, highlighting the importance of addressing misconceptions and providing realistic expectations about pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding Cancer Survivors' Educational Needs About Prescription Opioid Medications: Implications for Cancer Education and Health Literacy. Tyson, DM., Chavez, MN., Lubrano, B., et al.[2023]

In a survey of 1190 cancer patients across 10 Asian countries, 86.2% reported experiencing moderate-to-severe pain, highlighting inadequate pain management, especially among those not receiving opioids.

Approximately 70% of patients reported adverse events from pain medications, which negatively impacted their daily activities and overall quality of life, indicating a need for better management strategies for both pain and treatment side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inadequate treatment practices for pain relief and adverse event management in cancer patients across 10 countries/regions in Asia: a call for greater efforts to improve standards for patient care. Ho, KY., Ahn, JS., Calimag, MM., et al.[2018]

Citations

1. mayoclinic.elsevierpure.com mayoclinic.elsevierpure.com/en/projects/achieving-equity-through-socioculturally-informed-digitally-enabl-7

Achieving Equity through SocioCulturally-informed, Digitally- ... In addition, we have leveraged electronic health records (EHRs) to en- able care teams to link symptomatic cancer patients with MMPC providers and resources.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06198010

A Collaborative Intervention for Improving Cancer Pain ... This clinical trial tests a collaborative pain management intervention (ASCENT) for improving cancer pain in rural and Hispanic cancer survivors.

3. reporter.nih.gov reporter.nih.gov/search/xojS5z-Fg0aCHBuVOfZ0pw/project-details/10539159

Project Details - NIH RePORTER A novel digitally enabled, collaborative approach to team based pain management can improve clinical outcomes and reduce longstanding and devastating ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/03/NCT06063603/Prot_SAP_000.pdf

ASCENT / 23-004139 Pilot Test of a Pain Management ... Hypothesis. This study will adapt intervention components that were previously validated in several pragmatic clinical trials:.

5. mayoclinic.elsevierpure.com mayoclinic.elsevierpure.com/en/projects/achieving-equity-through-socioculturally-informed-digitally-enabl-7/fingerprints/

Achieving Equity through SocioCulturally-informed, ... Clinical Trials 100% · Cancer Pain Management 100% · Collaborative Care 100% · Team-based Care 83% · Electronic Health Records 66% · Hispanic 66% · Survivors 50%.

6. reporter.nih.gov reporter.nih.gov/search/kJPOT1QdmEmaz1JRo3BaKA/project-details/10933565

Project Details Abstract Cancer pain disparities are profound and uniquely harmful among Hispanic/Latinx and rural dwelling survivors as they undermine their already ...

7. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct06198010

A Collaborative Intervention for Improving Cancer Pain ... This clinical trial tests a collaborative pain management intervention (ASCENT) for improving cancer pain in rural and Hispanic cancer survivors.