Legal Support for Colorectal Cancer

Overseen By Arjun Gupta, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Minnesota

Disqualifiers: Diminished capacity to consent

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single center single-arm, pilot study of proactive and early connection with free legal care services for persons with advanced colorectal cancer to assess the feasibility, acceptability, and preliminary efficacy of this intervention in improving financial and psychosocial outcomes. Participants will receive free, personalized legal care services from Cancer Legal Care (CLC), a nonprofit organization located in the Twin Cities of Minnesota. The duration of study participation is 6 months, however, participants may continue to access free personalized legal care services beyond this period. All participants continue to receive standard of care as prescribed by their treating physician.

Do I have to stop taking my current medications for this trial?

The trial does not specify whether you need to stop taking your current medications. However, it mentions that all participants will continue to receive standard care as prescribed by their treating physician, so it's likely you can keep taking your current meds.

Do I need to stop my current medications for this trial?

The trial does not specify whether you need to stop taking your current medications. It mentions that all participants will continue to receive standard care as prescribed by their treating physician, so it's likely you can keep taking your current medications.

What data supports the idea that Legal Support for Colorectal Cancer is an effective treatment?

The available research does not provide specific data supporting the effectiveness of Legal Support for Colorectal Cancer as a treatment. The studies focus on medical and surgical management, patient care pathways, and follow-up processes, but do not mention legal support as a treatment method. Therefore, there is no direct evidence from the provided information to support the effectiveness of Legal Support for Colorectal Cancer. ^{1 2 3 4 5}

What safety data exists for the Legal Support for Colorectal Cancer treatment?

The provided research does not contain any safety data related to the Legal Support for Colorectal Cancer treatment or its alternative names. The studies focus on surgical outcomes, complications, and costs associated with colorectal cancer surgery, but do not address legal support services. ^{6 7 8 9 10}

Is Personalized Legal Care Services a promising treatment for colorectal cancer?

Personalized Legal Care Services could be promising because it might help patients manage their care better by providing support and guidance. This can lead to improved communication and decision-making, which are important for effective treatment. ^{5 10 11 12 13}

How is the treatment 'Personalized Legal Care Services' unique for colorectal cancer?

Personalized Legal Care Services is unique because it focuses on providing legal support to patients with colorectal cancer, which is not a standard part of medical treatment. This service aims to address legal issues that may arise during cancer care, offering a novel approach to support patients beyond traditional medical treatments. ^{5 10 11 12 13}

Research Team

Arjun Gupta, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for adults over 18 with advanced stage colorectal cancer who can speak, read, and write English. They should expect to live more than 6 months and be able to give written consent. The study excludes those not meeting these criteria.

Inclusion Criteria

My doctor believes I have more than 6 months to live.

I can sign a consent form for research activities.

I can understand and communicate in English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive free, personalized legal care services from Cancer Legal Care (CLC) to improve financial and psychosocial outcomes

6 months

Regular check-ins as needed

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

Extension

Participants may continue to access free personalized legal care services beyond the initial study period

Long-term

Treatment Details

Interventions

• Personalized Legal Care Services

Trial Overview The study tests the impact of free personalized legal care services on financial and psychosocial outcomes for people with advanced colorectal cancer. It's a single-arm pilot study where participants also receive their usual medical care.

Participant Groups

Group I: Experimental group Experimental Treatment 1 Intervention

adult patients with advanced colorectal cancel

Personalized Legal Care Services is already approved in United States for the following indications:

Approved in United States as Personalized Legal Care Services for:

• Support for patients with advanced colorectal cancer

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

A survey conducted by the International Working Group in Colorectal Cancer included 319 oncologists and 103 oncology nurses across Europe and the U.S., leading to the development of a Patient Management Model aimed at optimizing care for advanced colorectal cancer.

The model emphasizes a multidisciplinary team approach, incorporating diverse treatment practices from different countries, and provides comprehensive recommendations on diagnosis, staging, and management strategies, including surgery, chemotherapy, and palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An international, multidisciplinary approach to the management of advanced colorectal cancer. International Working Group in Colorectal Cancer. Wilke, H.[2019]

Healthcare professionals recognize the importance of combining standardised perioperative care with person-centred care for colorectal cancer patients, emphasizing the need for strong interactions and relationships between patients and providers.

Despite the recognition of its importance, there is a gap between the ideals of person-centred care and its actual implementation in clinical practice, highlighting the need for structural improvements to facilitate better patient participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Following a standardised pathway: Healthcare professionals' perspectives on person-centred care within ERAS for patients with colorectal cancer. Petersson, Å., Hellström, A., Assarsson, J., et al.[2023]

A survey of 179 colorectal cancer surgery patients revealed that while most received adequate care in many areas, significant gaps exist in critical information and support, particularly regarding post-surgery care and emotional support.

Key areas needing improvement include providing information on surgical wait-times, pre-habilitation behaviors, and dietary or exercise advice after discharge, with some aspects like dietary advice being received by only 25-31% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Provision of Perioperative Information and Care by Patients Who Have Undergone Surgery for Colorectal Cancer: A Cross-Sectional Study. Zucca, A., Mansfield, E., Sanson-Fisher, R., et al.[2023]

Surgeon expertise and case volume are linked to better tumor control in colorectal cancer, suggesting that patients treated by high-volume surgeons may have improved outcomes, including a lower likelihood of requiring a permanent colostomy.

Disparities in treatment and outcomes exist based on race and socioeconomic status, with black patients receiving less aggressive therapy and having higher mortality rates, although these differences can be mitigated when they receive comparable treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of patient and provider characteristics on the treatment and outcomes of colorectal cancer. Hodgson, DC., Fuchs, CS., Ayanian, JZ.[2021]

A nurse-led follow-up clinic for colorectal cancer effectively monitored 950 patients over 7 years, with 73% of those discharged being disease-free after 5 years, demonstrating the program's efficacy in managing patient care.

The clinic successfully identified recurrence and metastasis rates comparable to traditional consultant follow-ups, allowing for timely referrals for palliative care or surgery, thus alleviating the burden on consultant services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The process and outcomes of a nurse-led colorectal cancer follow-up clinic. McFarlane, K., Dixon, L., Wakeman, CJ., et al.[2019]

Over a 10-year period, the number of patients dying after colorectal cancer surgery significantly decreased, indicating improvements in surgical care and outcomes.

Increased involvement of consultant surgeons and anaesthetists was associated with a notable reduction in adverse events, particularly a 67% decrease in critical care-related issues, although there was a concerning rise in anastomotic leakage rates from 8% to 19%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the high dependency unit, increased consultant involvement and reduction in adverse events in patients who die after colorectal cancer surgery. Young, JA., Waugh, L., McPhillips, G., et al.[2018]

In a study of 35,946 colorectal cancer patients aged 66 and older, 27.2% experienced surgical complications within 30 days, and 13.4% of those with complications died, highlighting significant risks associated with surgery.

Factors such as poverty rates in the patient's census tract, the type of cancer (colon vs. rectal), and whether the surgery was an emergency increased the risk of complications and death, suggesting that targeted quality improvement efforts could help reduce these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital and geographic variability in two colorectal cancer surgery outcomes: complications and mortality after complications. Schootman, M., Lian, M., Pruitt, SL., et al.[2021]

The study analyzed 90-day mortality rates from colorectal cancer surgeries performed by 788 surgeons across 143 hospitals, revealing a national average mortality rate of 2.6%, but found no significant correlation between surgeon or hospital case volume and mortality rates.

Concerns were raised about data completeness, with nearly 5% of cases missing in individual surgeon analyses, and one-third of hospitals reporting less than 90% case ascertainment, highlighting the need for improved data collection methods to ensure reliable public reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time to rethink surgeon-specific outcome data for colorectal surgeons in England: Cross-sectional data of 73,842 resections for colorectal cancer. Hureibi, K., Evans, C., Wong, L., et al.[2022]

Complications after colorectal cancer surgery account for 31% of total hospital costs, with the most expensive 5% of patients responsible for 23% of hospital budgets, highlighting the financial impact of surgical complications.

Specific risk factors such as ASA IV status, double tumors, and advanced TNM-4 stage disease significantly contribute to increased costs, suggesting that targeted quality improvement programs could lead to substantial cost savings by reducing these complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Costs of complications after colorectal cancer surgery in the Netherlands: Building the business case for hospitals. Govaert, JA., Fiocco, M., van Dijk, WA., et al.[2015]

Patients with colorectal cancer liver metastases (CRLM) expressed strong support for using digital platforms to consult specialists, believing it could enhance their chances for potentially curative treatments and reduce waiting times for care.

Confidence in the expertise of physicians was crucial for patients, highlighting the importance of effective communication and coordination in their treatment journey, despite concerns about privacy risks associated with digital data exchange.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives of patients with colorectal cancer liver metastases on e-consultation in transmural care: a qualitative study : Is privacy really an issue? Hellingman, T., van Beneden, MLH., den Bakker, CM., et al.[2023]

Effective care for colorectal cancer involves not just treatment, but also managing symptoms and maintaining open communication with patients throughout their journey, from diagnosis to end-of-life care.

A multidisciplinary team approach is essential in providing comprehensive care, ensuring that patient preferences are considered in their treatment plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom management of advanced colorectal cancer. Griffin-Sobel, JP.[2011]

Telephone follow-up for colorectal cancer patients, conducted by experienced nurse specialists, is cost-effective and well-accepted by patients, providing effective symptom management and reassurance.

This method of follow-up is at least as effective as traditional face-to-face appointments in meeting patients' needs, suggesting it could enhance the overall care experience for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A literature review of the potential of telephone follow-up in colorectal cancer. Cusack, M., Taylor, C.[2010]

In a survey of 1301 patients with stage III colorectal cancer, those who received peer support were nearly three times more likely to adhere to adjuvant chemotherapy, indicating that peer support can significantly improve treatment acceptance.

Patients exposed to peer support reported more positive attitudes toward chemotherapy, suggesting that such programs could enhance patient coping and expectations regarding cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Peer Support on Colorectal Cancer Patients' Adherence to Guideline-Concordant Multidisciplinary Care. Kanters, AE., Morris, AM., Abrahamse, PH., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

An international, multidisciplinary approach to the management of advanced colorectal cancer. International Working Group in Colorectal Cancer. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Following a standardised pathway: Healthcare professionals' perspectives on person-centred care within ERAS for patients with colorectal cancer. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Perceived Provision of Perioperative Information and Care by Patients Who Have Undergone Surgery for Colorectal Cancer: A Cross-Sectional Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of patient and provider characteristics on the treatment and outcomes of colorectal cancer. [2021]

5. England pubmed.ncbi.nlm.nih.gov

The process and outcomes of a nurse-led colorectal cancer follow-up clinic. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Use of the high dependency unit, increased consultant involvement and reduction in adverse events in patients who die after colorectal cancer surgery. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Hospital and geographic variability in two colorectal cancer surgery outcomes: complications and mortality after complications. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Time to rethink surgeon-specific outcome data for colorectal surgeons in England: Cross-sectional data of 73,842 resections for colorectal cancer. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Costs of complications after colorectal cancer surgery in the Netherlands: Building the business case for hospitals. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Perspectives of patients with colorectal cancer liver metastases on e-consultation in transmural care: a qualitative study : Is privacy really an issue? [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Symptom management of advanced colorectal cancer. [2011]

12. England pubmed.ncbi.nlm.nih.gov

A literature review of the potential of telephone follow-up in colorectal cancer. [2010]

13. United States pubmed.ncbi.nlm.nih.gov

The Effect of Peer Support on Colorectal Cancer Patients' Adherence to Guideline-Concordant Multidisciplinary Care. [2022]