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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines support strategies for individuals with locally advanced rectal cancer beginning a complex treatment plan. It aims to determine if a brief psychoeducational program, called PATHWAYS, provides more benefit than usual care. Participants in the PATHWAYS group receive coaching sessions and educational materials, while the usual care group receives an online information guide. Ideal participants are those recently diagnosed with stage II or III rectal cancer and are about to start treatment that combines several methods. As an unphased trial, this study offers a unique opportunity to contribute to innovative support strategies for cancer patients.

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 prior data suggests that the PATHWAYS intervention is safe for patients with rectal cancer?

Research has shown that the PATHWAYS program, which includes coaching sessions and educational materials, is designed to assist patients with rectal cancer. This support aims to enhance quality of life and emotional well-being during cancer treatment. As the program is non-invasive and involves coaching and educational resources, it does not have known physical side effects like those sometimes associated with medications or surgeries.

The trial is in the "Not Applicable" phase, meaning it does not test drugs or devices, so specific safety data is not required. Instead, the focus is on the program's acceptability and practicality for participants.

Overall, because PATHWAYS involves coaching and educational support, it is considered safe for participants. It aims to help patients manage the stress and challenges of cancer treatment without introducing new physical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PATHWAYS intervention for rectal cancer because it offers a personalized approach through coaching sessions, which is not a standard part of current treatments like surgery, chemotherapy, or radiation. This method focuses on empowering patients with education and support, potentially improving their quality of life and treatment adherence. By refining the intervention based on patient feedback, PATHWAYS aims to provide more effective supportive care tailored to individual needs, which could enhance overall treatment outcomes.

What evidence suggests that the PATHWAYS intervention could be effective for rectal cancer?

Research shows that educational and emotional support can improve well-being for cancer patients. In past studies, similar support programs have helped patients understand their treatment better and manage stress. This type of support may enhance mental health during challenging cancer treatments. In this trial, participants will join different arms to evaluate the effectiveness of the PATHWAYS program. The PATHWAYS Intervention arm provides structured coaching sessions and educational materials, while the Enhanced Usual Care arm offers an information resource guide for navigating information online. Although specific data on the PATHWAYS program for rectal cancer is limited, this approach is expected to address patients' mental and emotional needs during medical treatment. ^{1 6 7 8 9}

Who Is on the Research Team?

Kelsey Lau-Min, MD, MSCE

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3092465/

Pathways, Outcomes, and Costs in Colon Cancer Pathways, Outcomes, and Costs in Colon Cancer: Retrospective Evaluations in Two Distinct Databases · Abstract. Purpose: · Introduction. Colorectal cancer (CRC) is ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9745824/

Integrated care pathway for rectal cancer treatment Over the last few decades, there have been major achievements in rectal cancer treatments, with the introduction of neoadjuvant therapy and total mesorectal ...

3. nature.com nature.com/articles/s41392-024-01953-7

Signaling pathways involved in colorectal cancer Given its significant role, targeting PGE2 presents a promising therapeutic strategy for colon cancer treatment. For example, the aqueous ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0748798322004073

Characteristics and fate of patients with rectal cancer not ... Rectal cancer occurs in about one-third of all patients with colorectal cancer (CRC), the second most frequent cancer affecting both sexes. The incidence varies ...

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Bridging Quality Gaps in Rectal Cancer Care—Lessons ... ... Program for Rectal Cancer in the National Cancer Database improve patient outcomes? ... colorectal cancer surgery: real-world data from the ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.00903

Patient-Reported Outcomes During and After Treatment for ... During neoadjuvant treatment, patients reported significantly lower rates of diarrhea and better overall bowel function with FOLFOX.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2813744

Organ Preservation and Survival by Clinical Response ... This secondary analysis of a randomized clinical trial assesses organ preservation and survival outcomes for patients with rectal cancer ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2949819824000281

Efficacy and safety of short-course radiotherapy versus ... Efficacy and safety of short-course radiotherapy versus total neoadjuvant therapy in older rectal cancer patients: a randomised pragmatic trial (SHAPERS).

9. mdpi.com mdpi.com/2072-6694/16/12/2194

Outcome of Patients with Locally Advanced Rectal Cancer ... In cT1-3N+ patients, NOM resulted in a 5-year OS of 73.9% (95% confidence interval [CI] = 69.7–77.6%) versus 84.5% (95% CI = 83.6–85.3%) with surgery (p < 0.001) ...