Recruiting

Observational Study

Sponsor:

Jewish General Hospital

Code:

NCT04966819

Conditions

Rectal Cancer

Low Anterior Resection Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Survivorship Care Initiative

Study Details

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

Study ID

NCT04966819

Start date

Mar 1, 2022

Status verified date

Aug, 2022

Completion date

Sep, 2024

Anticipated

Primary completion date

Sep, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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

no intervention: 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).

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.

Primary outcome measure

  • Short Form-Survivor Unmet Needs Survey (Unmet needs) at 12 months [ Time Frame: 12 months after study start ]

Central Contacts and Locations

Locations

Jewish General Hospital

Recruiting

Montréal, Quebec, Canada, H3T1E2

Contacts

More Information

Sponsor

Jewish General Hospital

Last update posted

Aug 19, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jewish General Hospital on 2022-08-19.