Continuity of CarePhase 3NCT00182234
SONICS - Effectiveness of Specialist Oncology Nursing
A Phase 3 study testing Community Interlink Program in people with Continuity of Care and Quality of Life, run by McMaster University.
Trial summary
This research project will address the issue of gaps in continuity of supportive care for cancer patients during the early phases of the disease trajectory that result in unmet needs and unnecessary morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuity of Care, Quality of Life
- What is being tested?
- Community Interlink Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 183 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Mar 2009
- Phase
- Phase 3
- 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
- Histologically confirmed breast or colorectal cancer.
- In the initial stages of surgical consultation within the randomized surgical practices.
- Not had previous or concomitant malignancies (except for: non-melanoma skin cancer, or carcinoma in situ of the cervix).
- Have been informed of cancer diagnosis by the surgical office.
- Reside in the Interlink adult program service area.
- Legally able to provide informed consent (18 years of age or older).
- Able to speak and read English.
- Patients from an intervention designated practice, must agree to referral to Interlink and to receiving an in-home needs assessment.
Who cannot join
None listed.
About this study
Official title: A Study of the Effectiveness of Specialist Oncology Nursing Case Management in Improving Continuity of Supportive Cancer Care in the Community (SONICS)
This research project will address the issue of gaps in continuity of supportive care for cancer patients during the early phases of the disease trajectory that result in unmet needs and unnecessary morbidity. The investigators intend to study the impact of a specialized cancer-nursing program, Interlink Community Cancer Nurses (Interlink) on patient outcomes. Impact will be assessed directly using a validated measure of continuity of care from the patients' perspective and validated measures of key supportive care patient outcomes including unmet needs, distress, uncertainty in illness, and quality of life, in a randomized trial.
Read the detailed description
Main Research Question: Does community-based specialist oncology nursing case management improve continuity of cancer care and lead to fewer unmet cancer patient needs?
Why this research is important: This research proposal addresses the issue of gaps in continuity of supportive care for cancer patients during the early phases of the disease trajectory that result in unmet needs and unnecessary morbidity, prior to entry into a formalized cancer care system (e.g., a regional cancer centre or hospital with a cancer treatment program). This initial diagnostic period of cancer is associated with significant stress, anxiety and uncertainty that can impact upon overall quality of life for all types of cancer. These problems are further exacerbated by waiting times of up to 16 weeks between diagnosis and attendance in a formalized cancer treatment system. During this time patients will face a fragmented supportive care service system resulting in a substantial number of patients reporting unmet needs and distress. These care gaps have significant implications considering that 38% of women and 41% of men will develop cancer during their lifetime and that cancer incidence continues to rise with an estimated 139,000 new cases in Canada (over 54,000 of these in Ontario) in 2003. There has been growing interest in nursing models to address these gaps in supportive cancer care but at this time there is not sufficient high quality evidence upon which to base policy decisions to support the widespread introduction of this type of model. The results of this study will be very important for policy development for community cancer care in Ontario and in other provinces in Canada.
What is being studied: We will study the impact of a specialized nursing intervention (Interlink) on patient outcomes early in the disease trajectory. Impact will be assessed directly using validated measures in a randomized controlled trial design. These measures will include: continuity of care, unmet needs, psychological distress, uncertainty in illness, and quality of life.
- Conditions
- Continuity of Care, Quality of Life
- Being tested
- Community Interlink Program
- Keywords
- unmet supportive care needs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Interlink ProgramBehavioural
Also called Interlink Community Cancer Nurses
The study intervention is a referral to a specialized oncology nursing program. The standardized care provided by this program includes comprehensive assessment and care planning specific to breast and colorectal cancers during the initial phases of treatment, with a minimum of two home visits. Through consultation with the patient, nurses either provide direct (non-medical) care to address needs identified and/or coordinate linkage to services in the community.
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in unmet supportive care needs between intervention and control group
Measured: 2 to 3 weeks after baseline; 8 to 10 weeks after baseline
Difference in continuity of care between intervention and control group
Measured: 2 to 3 weeks after baseline; 8 to 10 weeks after baseline
Difference in quality of life between intervention and control group
Measured: 2 to 3 weeks after baseline; 8 to 10 weeks after baseline
Secondary outcomes (3)
Difference in uncertainty in illness between intervention and control group
Measured: 2 to 3 weeks after baseline; 8 to 10 weeks after baseline
Difference in use of resources between intervention and control group
Measured: 2 to 3 weeks after baseline; 8 to 10 weeks after baseline
Acute stress following surgery
Measured: 8 to 10 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2005
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Continuity of CareStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ontario Ministry of Health and Long Term Care
- Investigators
- Jonathan Sussman, MD, CCFP, FRCP (c), MSc, Principal investigator, Supportive Cancer Care Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182234
- Sponsor's protocol ID
- 74867
- Other IDs
- CIHR - 74867, MOHLTC - 04171
- Status last verified
- Jun 2009
- First submitted
- 13 Sep 2005
- Last updated
- 18 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Sussman J, Bainbridge D, Whelan TJ, Brazil K, Parpia S, Wiernikowski J, Schiff S, Rodin G, Sergeant M, Howell D. Evaluation of a specialized oncology nursing supportive care intervention in newly diagnosed breast and colorectal cancer patients following surgery: a cluster randomized trial. Support Care Cancer. 2018 May;26(5):1533-1541. doi: 10.1007/s00520-017-3981-4. Epub 2017 Nov 30.
PubMed 29189967
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effectiveness of Specialist Oncology Nursing Case Management in Improving Continuity of Supportive Cancer Care in the Community (SONICS)
- ClinicalTrials.gov ID
- NCT00182234
- Acronym / sponsor ID
- 74867
- Conditions
- Continuity of Care, Quality of Life
- Keywords
- unmet supportive care needs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ontario Ministry of Health and Long Term Care
- Study start
- Dec 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 16 Sep 2005 (estimated)
- 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.
This research project will address the issue of gaps in continuity of supportive care for cancer patients during the early phases of the disease trajectory that result in unmet needs and unnecessary morbidity. The investigators intend to study the impact of a specialized cancer-nursing program, Interlink Community Cancer Nurses (Interlink) on patient outcomes. Impact will be assessed directly using a validated measure of continuity of care from the patients' perspective and validated measures of key supportive care patient outcomes including unmet needs, distress, uncertainty in illness, and quality of life, in a randomized trial.
Detailed description
Main Research Question: Does community-based specialist oncology nursing case management improve continuity of cancer care and lead to fewer unmet cancer patient needs?
Why this research is important: This research proposal addresses the issue of gaps in continuity of supportive care for cancer patients during the early phases of the disease trajectory that result in unmet needs and unnecessary morbidity, prior to entry into a formalized cancer care system (e.g., a regional cancer centre or hospital with a cancer treatment program). This initial diagnostic period of cancer is associated with significant stress, anxiety and uncertainty that can impact upon overall quality of life for all types of cancer. These problems are further exacerbated by waiting times of up to 16 weeks between diagnosis and attendance in a formalized cancer treatment system. During this time patients will face a fragmented supportive care service system resulting in a substantial number of patients reporting unmet needs and distress. These care gaps have significant implications considering that 38% of women and 41% of men will develop cancer during their lifetime and that cancer incidence continues to rise with an estimated 139,000 new cases in Canada (over 54,000 of these in Ontario) in 2003. There has been growing interest in nursing models to address these gaps in supportive cancer care but at this time there is not sufficient high quality evidence upon which to base policy decisions to support the widespread introduction of this type of model. The results of this study will be very important for policy development for community cancer care in Ontario and in other provinces in Canada.
What is being studied: We will study the impact of a specialized nursing intervention (Interlink) on patient outcomes early in the disease trajectory. Impact will be assessed directly using validated measures in a randomized controlled trial design. These measures will include: continuity of care, unmet needs, psychological distress, uncertainty in illness, and quality of life.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed breast or colorectal cancer.
- In the initial stages of surgical consultation within the randomized surgical practices.
- Not had previous or concomitant malignancies (except for: non-melanoma skin cancer, or carcinoma in situ of the cervix).
- Have been informed of cancer diagnosis by the surgical office.
- Reside in the Interlink adult program service area.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Community Interlink ProgramAlso: Interlink Community Cancer NursesThe study intervention is a referral to a specialized oncology nursing program. The standardized care provided by this program includes comprehensive assessment and care planning specific to breast and colorectal cancers during the initial phases of treatment, with a minimum of two home visits. Through consultation with the patient, nurses either provide direct (non-medical) care to address needs identified and/or coordinate linkage to services in the community. | Behavioural | – |
Primary outcome
Difference in unmet supportive care needs between intervention and control group
Time frame: 2 to 3 weeks after baseline; 8 to 10 weeks after baseline
Difference in continuity of care between intervention and control group
Time frame: 2 to 3 weeks after baseline; 8 to 10 weeks after baseline
Difference in quality of life between intervention and control group
Time frame: 2 to 3 weeks after baseline; 8 to 10 weeks after baseline
3 secondary outcomes
Difference in uncertainty in illness between intervention and control group
Time frame: 2 to 3 weeks after baseline; 8 to 10 weeks after baseline
Difference in use of resources between intervention and control group
Time frame: 2 to 3 weeks after baseline; 8 to 10 weeks after baseline
Acute stress following surgery
Time frame: 8 to 10 weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2009.
- Derived from this study: PubMed 29189967Sussman J, Bainbridge D, Whelan TJ, Brazil K, Parpia S, Wiernikowski J, Schiff S, Rodin G, Sergeant M, Howell D. Evaluation of a specialized oncology nursing supportive care intervention in newly diagnosed breast and colorectal cancer patients following surgery: a cluster randomized trial. Support Care Cancer. 2018 May;26(5):1533-1541. doi: 10.1007/s00520-017-3981-4. Epub 2017 Nov 30.
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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.
Jonathan Sussman, MD, CCFP, FRCP (c), MSc principal investigator
Supportive Cancer Care Research Unit
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Community Interlink Program in people with Continuity of Care and Quality of Life, run by McMaster University.
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 8 inclusion and 0 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: finished, as of the sponsor's last update on 18 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in unmet supportive care needs between intervention and control group (time frame: 2 to 3 weeks after baseline; 8 to 10 weeks after baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182234, which also lists 1 linked publication.
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 18 Jun 2009.