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Rectal Cancer Shared Care

Primary Purpose

Rectal Cancer, Low Anterior Resection Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Survivorship Care Initiative
Sponsored by
Jewish General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jewish General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Survivorship Care

Standard Care

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

National Comprehensive Cancer Network Distress Thermometer
Score ranges from 0 (no distress) to 10 (extreme distress). Higher score means higher distress.
Global Quality of Life (QoL)
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.
Short Form-Survivor Unmet Needs Survey (Unmet needs)
Score ranges from 0 to 4. Higher score means higher degree of unmet needs.

Full Information

First Posted
July 5, 2021
Last Updated
August 17, 2022
Sponsor
Jewish General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04966819
Brief Title
Rectal Cancer Shared Care
Official Title
Assessing Current Survivorship Care Needs of Rectal Cancer Patients and Piloting a Dedicated Survivorship Initiative
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jewish General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Low Anterior Resection Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Survivorship Care
Arm Type
Experimental
Arm Description
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
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Survivorship Care Initiative
Intervention Description
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 Information:
Title
Short Form-Survivor Unmet Needs Survey (Unmet needs) at 12 months
Description
Score ranges from 0 to 4. Higher score means higher degree of unmet needs.
Time Frame
12 months after study start
Secondary Outcome Measure Information:
Title
National Comprehensive Cancer Network Distress Thermometer
Description
Score ranges from 0 (no distress) to 10 (extreme distress). Higher score means higher distress.
Time Frame
Baseline, 3, 6, and 12 months after study start
Title
Global Quality of Life (QoL)
Description
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.
Time Frame
Baseline, 3, 6, and 12 months after study start
Title
Short Form-Survivor Unmet Needs Survey (Unmet needs)
Description
Score ranges from 0 to 4. Higher score means higher degree of unmet needs.
Time Frame
Baseline, 3, and 6 months after study start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Sabboobeh, MSc
Phone
5143408222
Ext
25996
Email
sarah.sabboobeh@ladydavis.ca
First Name & Middle Initial & Last Name & Degree
Jenny Moon, MD
Phone
5145676370
Email
jeongyoon.moon@mail.mcgill.ca

12. IPD Sharing Statement

Learn more about this trial

Rectal Cancer Shared Care

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