Supportive Care for Rectal Cancer

(PATHWAYS Trial)

Recruiting at 1 trial location

Overseen By Kelsey Lau-Min, MD, MSCE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Prior colorectal cancer, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 8

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of this study is to evaluate the feasibility and acceptability of conducting a randomized trial of a brief psychoeducational intervention versus enhanced usual care for patients with locally advanced rectal cancer who are initiating neoadjuvant multimodality treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment PATHWAYS for rectal cancer?

The research suggests that using a well-organized treatment plan, or pathway, involving teamwork among different specialists can improve the overall results for colorectal cancer patients. This approach has been shown to enhance patient care by reducing complications and improving recovery after surgery. ^{1 2 3 4 5}

Is the supportive care treatment for rectal cancer safe for humans?

The research on clinical pathways for cancer, including colorectal cancer, suggests that safety is considered by evaluating toxicity (harmful effects) alongside effectiveness. For example, in the S-1 chemotherapy pathway for gastric cancer, safety measures like monitoring for adverse reactions and adjusting doses were used to ensure patient safety. ^{2 3 6 7 8}

How does the supportive care treatment for rectal cancer differ from other treatments?

The supportive care treatment for rectal cancer is unique because it involves an integrated care pathway that organizes a multidisciplinary team to manage the complex multimodality therapy, including neoadjuvant chemoradiotherapy and surgery, which is not typically emphasized in standard treatments. ^{2 3 6 9 10}

Research Team

Kelsey Lau-Min, MD, MSCE

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 with newly diagnosed stage II or III locally advanced rectal cancer, who are starting combined treatments. Participants must be able to complete study tasks in English or with an interpreter's help.

Inclusion Criteria

I decided to undergo combined treatments for my stage II or III rectal cancer within the last 4 weeks.

Able to complete study procedures in English or with the assistance of an interpreter

Exclusion Criteria

I have been treated for colorectal cancer before.

Comorbid health condition that would interfere with study participation, as identified by cancer care team

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Study Phase I

Feasibility and acceptability of a psychoeducational intervention relative to a control condition

4 weeks

4 coaching sessions

Study Phase II

Efficacy of the refined psychoeducational intervention

12 weeks

4 coaching sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• PATHWAYS

Trial Overview The trial tests a brief psychoeducational program called PATHWAYS against enhanced usual care to see if it can boost patients' confidence in managing their rectal cancer treatment and its effects.

Participant Groups

Group I: Study Phase II: PATHWAYS Intervention Experimental Treatment 1 Intervention

Participants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions and 2) a comprehensive patient education guidebook. The intervention has been modified and refined based on feedback from Study Phase I.

Group II: Study Phase I: PATHWAYS Intervention Experimental Treatment 1 Intervention

Participants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions, 2) a comprehensive patient education guidebook, and 3) a coaching session workbook.

Group III: Study Phase I: Enhanced Usual Care Active Control 1 Intervention

Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.

Group IV: Study Phase II: Enhanced Usual Care Active Control 1 Intervention

Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

In a study of 46,692 elderly colorectal cancer patients, those receiving intravenous chemotherapy experienced significantly higher rates of adverse events, particularly with oxaliplatin-based regimens, which caused more nausea, neutropenia, and neuropathy compared to fluorouracil alone.

Patients aged 70 and older were more likely to suffer from adverse effects such as infection, anemia, delirium, and heart disease, highlighting the need for careful patient selection and support when administering chemotherapy to older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of toxicity profiles of fluorouracil versus oxaliplatin regimens in a large population-based cohort of elderly patients with colorectal cancer. Cen, P., Liu, C., Du, XL.[2020]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Self-evaluation of a clinical pathway to improve the results of rectal cancer]. [2010]

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

In the absence of evidence, who chooses? A qualitative study of patients' needs after treatment for colorectal cancer. [2018]

3. Finland pubmed.ncbi.nlm.nih.gov

[Streamlined treatment pathway for a colorectal cancer patient]. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Development of a model care pathway for adults undergoing colorectal cancer surgery: Evidence-based key interventions and indicators. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

[Interdisciplinary clinical pathway for colorectal cancer]. [2018]

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

Clinical Pathways: Management of Quality and Cost in Oncology Networks in the Metastatic Colorectal Cancer Setting. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Comparison of toxicity profiles of fluorouracil versus oxaliplatin regimens in a large population-based cohort of elderly patients with colorectal cancer. [2020]

8. Japan pubmed.ncbi.nlm.nih.gov

Development of clinical pathway in S-1 chemotherapy for gastric cancer. [2022]

9. Brazil pubmed.ncbi.nlm.nih.gov

Integrated care pathway for rectal cancer treatment: cross-sectional post-implementation study using a logic model framework. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Long-term effects of a regional care pathway for patients with rectal cancer. [2018]