Rectal Cancer Shared Care

NCT ID: NCT04966819

Last Updated: 2022-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-09-30

Brief Summary

The investigators propose a multifaceted rectal cancer survivorship care program involving oncology specialists, nursing support and primary care physicians. This initiative centers on regular meetings with oncology nursing support, enhanced communication and coordination of care among clinicians including primary care physicians, and an educational platform for patients regarding the late and long-term effects of cancer. Initial efforts will target rectal cancer patients specifically as they have been identified as being at high risk of having unmet needs. Once we have realized measurable, successful implementation in this population, our hope is then to expand our initiative to all colon cancer patients.

Detailed Description

Rectal cancer is a life-altering diagnosis that can have long-lasting effects not only on one's physical health, but also their psychological, emotional and financial well-being. With advancements in both disease detection and therapeutic options, there is now a growing cohort of patients who have successfully completed active rectal cancer treatment and transitioned into post-treatment care. Unfortunately, the post-treatment phase has its own set of challenges. Lost in Transition was one of the first major publications to advocate for dedicated survivorship planning, raising awareness of the needs of cancer survivors. Since then, both the National Comprehensive Cancer Network (NCCN) and the American Cancer Society have released guidelines for survivorship care focused on prevention, surveillance, assessment, intervention, coordination of care and survivorship planning. Despite these efforts to bolster survivorship care, studies have found an average of 2.88 unmet needs among cancer survivors affecting physical, financial, educational, emotional and psychology domains. The investigators propose a multifaceted rectal cancer survivorship care program involving oncology specialists, nursing support and primary care physicians. This initiative centers on regular meetings with oncology nursing support, enhanced communication and coordination of care among clinicians including primary care physicians, and an educational platform for patients regarding the late and long-term effects of cancer. Initial efforts will target rectal cancer patients specifically as they have been identified as being at high risk of having unmet needs. Once the investigators have realized measurable, successful implementation in this population, the hope is then to expand this initiative to all colon cancer patients.

Conditions

Rectal Cancer; Low Anterior Resection Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Survivorship Care

Survivorship care will consist of:

1. Regular meetings with the rectal cancer oncology pivot nurse

2. Identification of a primary care physician

3. Development of an individualized survivorship plan

4. Educational resources for patients

Group Type: EXPERIMENTAL

Survivorship Care Initiative

Intervention Type: OTHER

The survivorship initiative will consist of:

(A) Regular meetings with the rectal cancer oncology pivot nurse (IPO). These meetings present an opportunity for patients to discuss any treatment-related distress or late and long-term side-effect.

(B) Identification of a primary care physician. If the patient is not known to a Primary care physician (PCP), the IPO will add the patient to an accelerated waitlist.

(C) Development of an individualized survivorship plan. During meetings with the oncology pivot nurse, a survivorship care plan will be populated, included information on patient risk factors, treatments completed, pathology findings, and future surveillance planned. This document will be reviewed by the treating colorectal surgeon, and will be subsequently shared with the oncology team, the PCP and the patient (if the patient desires).

(D) Educational resources for patients. Patients will be offered educational materials to help address their specific needs.

Standard Care

The control arm will consist of patients treated at the same institution who are receiving standard of care. Standard of care consists of meeting with colorectal oncology pivot nurse as needed (i.e. by referral from specialist based on patient needs).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Survivorship Care Initiative

The survivorship initiative will consist of:

(A) Regular meetings with the rectal cancer oncology pivot nurse (IPO). These meetings present an opportunity for patients to discuss any treatment-related distress or late and long-term side-effect.

(B) Identification of a primary care physician. If the patient is not known to a Primary care physician (PCP), the IPO will add the patient to an accelerated waitlist.

(C) Development of an individualized survivorship plan. During meetings with the oncology pivot nurse, a survivorship care plan will be populated, included information on patient risk factors, treatments completed, pathology findings, and future surveillance planned. This document will be reviewed by the treating colorectal surgeon, and will be subsequently shared with the oncology team, the PCP and the patient (if the patient desires).

(D) Educational resources for patients. Patients will be offered educational materials to help address their specific needs.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult (>18 years-old)
• rectal cancer patients who underwent curative intent treatment between 2019-2020 (i.e. in the last 2 years), including those who underwent surgical resection (abdominoperineal resection or restorative proctectomy with or without ileostomy) and those managed non-operatively, with chemoradiotherapy will be included.

Exclusion Criteria

• Cannot be contacted by telephone
• Unable to read and comprehend English or French;
• Unable to give clear and informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Marylise Boutros

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jewish General Hospital

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Sarah Sabboobeh, MSc

Role: primary

sarah.sabboobeh@ladydavis.ca

5143408222 ext. 25996

Jenny Moon, MD

Role: backup

jeongyoon.moon@mail.mcgill.ca

5145676370

Other Identifiers

2020-1995

Identifier Type: -

Identifier Source: org_study_id