Rectal Cancer Shared Care

Sponsor
Jewish General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04966819
Collaborator
(none)
80
1
2
30.1
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Survivorship Care Initiative
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Supportive Care
Official Title:
Assessing Current Survivorship Care Needs of Rectal Cancer Patients and Piloting a Dedicated Survivorship Initiative
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Survivorship Care

Survivorship care will consist of: Regular meetings with the rectal cancer oncology pivot nurse Identification of a primary care physician Development of an individualized survivorship plan Educational resources for patients

Other: 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.

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).

Outcome Measures

Primary Outcome Measures

  1. Short Form-Survivor Unmet Needs Survey (Unmet needs) at 12 months [12 months after study start]

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

Secondary Outcome Measures

  1. National Comprehensive Cancer Network Distress Thermometer [Baseline, 3, 6, and 12 months after study start]

    Score ranges from 0 (no distress) to 10 (extreme distress). Higher score means higher distress.

  2. Global Quality of Life (QoL) [Baseline, 3, 6, and 12 months after study start]

    Global QoL as measured by the European Organization for Research & Treatment of Cancer QoL questionnaire (EORTC QLQ-C30). Linear transformation is used to standardize raw score, so that scores range from 0 to 100; higher score represents better functioning or worse level of symptoms.

  3. Short Form-Survivor Unmet Needs Survey (Unmet needs) [Baseline, 3, and 6 months after study start]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jewish General Hospital Montréal Quebec Canada H3T1E2

Sponsors and Collaborators

  • Jewish General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Marylise Boutros, Associate Professor, Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT04966819
Other Study ID Numbers:
  • 2020-1995
First Posted:
Jul 19, 2021
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2022