Rectal CancerNCT04966819
Rectal Cancer Shared Care
A study testing Survivorship Care Initiative in people with Rectal Cancer and Low Anterior Resection Syndrome, run by Jewish General Hospital at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Low Anterior Resection Syndrome
- What is being tested?
- Survivorship Care Initiative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2022to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cannot be contacted by telephone
- Unable to read and comprehend English or French;
- Unable to give clear and informed consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T1E2
Sarah Sabboobeh, MSc, 5143408222 ext. 25996, sarah.sabboobeh@ladydavis.ca
Jenny Moon, MD, 5145676370, jeongyoon.moon@mail.mcgill.ca
About this study
Official title: Assessing Current Survivorship Care Needs of Rectal Cancer Patients and Piloting a Dedicated Survivorship Initiative
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.
Read the 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
- Being tested
- Survivorship Care Initiative
- Medical subject headings
- Rectal Neoplasms, Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survivorship Care InitiativeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after study start
Secondary outcomes (3)
National Comprehensive Cancer Network Distress Thermometer
Score ranges from 0 (no distress) to 10 (extreme distress). Higher score means higher distress.
Measured: Baseline, 3, 6, and 12 months after study start
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.
Measured: Baseline, 3, 6, and 12 months after study start
Short Form-Survivor Unmet Needs Survey (Unmet needs)
Score ranges from 0 to 4. Higher score means higher degree of unmet needs.
Measured: Baseline, 3, and 6 months after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Mar 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Marylise Boutros, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966819
- Sponsor's protocol ID
- 2020-1995
- Status last verified
- Aug 2022
- First submitted
- 5 Jul 2021
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Current Survivorship Care Needs of Rectal Cancer Patients and Piloting a Dedicated Survivorship Initiative
- ClinicalTrials.gov ID
- NCT04966819
- Acronym / sponsor ID
- 2020-1995
- Conditions
- Rectal Cancer, Low Anterior Resection Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivorship Care | Experimental | Other: Survivorship Care InitiativeSurvivorship 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 |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Cannot be contacted by telephone
- Unable to read and comprehend English or French;
- Unable to give clear and informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survivorship Care InitiativeThe 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. | Other | Survivorship Care |
Primary outcome
Short Form-Survivor Unmet Needs Survey (Unmet needs) at 12 months
Time frame: 12 months after study start
Score ranges from 0 to 4. Higher score means higher degree of unmet needs.
3 secondary outcomes
National Comprehensive Cancer Network Distress Thermometer
Time frame: Baseline, 3, 6, and 12 months after study start
Global Quality of Life (QoL)
Time frame: Baseline, 3, 6, and 12 months after study start
Short Form-Survivor Unmet Needs Survey (Unmet needs)
Time frame: Baseline, 3, and 6 months after study start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survivorship Care Initiative in people with Rectal Cancer and Low Anterior Resection Syndrome, run by Jewish General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form-Survivor Unmet Needs Survey (Unmet needs) at 12 months (time frame: 12 months after study start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.