Rectal Cancer Shared Care

NCT04966819 | Unknown

• 1 other identifier: 2020-1995
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer; Low Anterior Resection Syndrome

Outcome Measures

Primary Outcomes (1)

• Short Form-Survivor Unmet Needs Survey (Unmet needs) at 12 months

  Score ranges from 0 to 4. Higher score means higher degree of unmet needs.

  12 months after study start

Secondary Outcomes (3)

• National Comprehensive Cancer Network Distress Thermometer

  Baseline, 3, 6, and 12 months after study start

• Global Quality of Life (QoL)

  Baseline, 3, 6, and 12 months after study start

• Short Form-Survivor Unmet Needs Survey (Unmet needs)

  Baseline, 3, and 6 months after study start

Study Arms (2)

Survivorship Care

EXPERIMENTAL

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

Other: Survivorship Care Initiative

Standard Care

NO INTERVENTION

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).

Interventions

Survivorship Care Initiative 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.

Survivorship Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Low Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, it is not possible to mask the participant nor the care provider. However, outcome assessor will be blinded to the treatment allocation when analyzing primary and secondary outcomes.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 19, 2021
• Study Start: March 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: August 19, 2022

Record last verified: 2022-08

Locations

CA (1)