Thyroid CancerPhase 1/2ITCA-ThyCaNCT01994200
Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients
A Phase 1/2 study testing Interdisciplinary Team-Based Approach in people with Thyroid Cancer, run by Jewish General Hospital at 1 site in Canada.
Trial summary
While thyroid cancer is generally associated with a favourable prognosis, there is a discrepancy with how important if not traumatic its impact can be on patients. Quality of life (QoL) decreases in the year following a thyroid cancer diagnosis, constituting an optimal period for a preventive intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Interdisciplinary Team-Based Approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Jun 2016
- Phase
- Phase 1/2
- 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
- Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system);
- Willing to participate in the EG meetings;
- >18 years;
- Alert and capable of giving free and informed consent;
- Able to speak and read English or French.
Who cannot join
- Anaplastic thyroid cancer;
- Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) For Newly Diagnosed Thyroid Cancer Patients: Randomized Controlled Trial
While thyroid cancer is generally associated with a favourable prognosis, there is a discrepancy with how important if not traumatic its impact can be on patients. Quality of life (QoL) decreases in the year following a thyroid cancer diagnosis, constituting an optimal period for a preventive intervention. The goal of this study is to evaluate the impact of offering an interdisciplinary team-based care approach for newly diagnosed thyroid cancer patients, including a dedicated nurse who will provide important psychoeducational elements identified in previous focus group studies of thyroid cancer patients, i.e., information on: the physical illness; the emotional impact of being newly diagnosed with thyroid cancer; surgery and its' short- and long-term consequences; radioactive iodine treatments and its associated safety precautions, nutrition and dietary considerations; and how the cancer diagnosis can be an opportunity to make important lifestyle changes and establish new life-priorities.
Read the detailed description
The investigators will conduct a 2-arm Randomized Controlled Trial comparing an Interdisciplinary Team-Based Care Approach to usual care.
The primary research question will be: Does adding the Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) to usual care (EG) increase levels of overall QoL among newly diagnosed thyroid cancer patients, compared with those receiving usual care (UC), at 9 months post-randomization (i.e., after all of the dedicated-nurse meetings are administered) as judged by scores on the Functional Assessment of Chronic Illness Therapy-General (FACT-G)? Primary hypothesis: The EG will report higher scores of overall QoL on the FACT-G than the UC at 9 months post-randomization.
Secondary research questions: The investigators plan to evaluate ITCA-ThyCa effects on secondary outcomes such as level of: physical health (SF-36 Physical Health subscale), mental health (SF-36 Mental Health subscale), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue; FACIT-F), anxiety and depression (Hospital Anxiety and Depression Scale; HADS), and negative illness perception (Illness Perception Questionnaire - Revised (IPQ-R). The investigators also plan to explore ITCA-ThyCa effects on satisfaction with care (16 questions of the NRC Picker satisfaction survey measuring patient satisfaction with care) and healthcare service use (types of professionals consulted, frequency of visits, and time elapsed between referral and first consultation). Hypotheses: The EG will report a higher level of physical and mental health on the SF-Physical and Mental Health subscales, respectively; and a lower level of fatigue on the FACIT-F, anxiety and depression on the HADS, and negative illness perception on the IPQ-R; compared with the UC at 9 months post-randomization.
All of the abovementioned changes will be present throughout the treatment, namely at 7-10 days and 5 months post-randomization (i.e., immediately after each of the meetings planned with the dedicated nurse).
All of the abovementioned changes will persist at 12 months post-randomization (i.e., corresponding to 6 months after all anti-cancer treatments are completed and 3 months after all dedicated-nurse meetings have been administered).
Feasibility and acceptability (9 first months of the trial):
The investigators plan on testing the feasibility and acceptability of the 2-arm RCT of ITCA-ThyCa during the first 9 months of the trial (once the investigators start recruiting, after the first 3-6 months dedicated to hiring our personnel and developing the manual of our approach). During this phase, the investigators will aim to address the following research questions:
- Can the investigators recruit a sufficient number of patients (i.e., a minimum of 60 patients over 6 months or 10/month) and retain a sufficient proportion of thyroid cancer patients (i.e., at least 80% at 7-10 days, 5 months or 9 months post-randomization) in both trial arms?
- Is ITCA-ThyCa acceptable to at least 80% of EG thyroid cancer patients? Secondary pilot study questions
- Which evaluation time should be primary post-randomization, based on an acceptable retention rate of 80%?
- What variance estimates can be used to inform calculation of sample size for the full study?
If the design remains the same following this pilot, the investigators aim to roll in the pilot data in the full trial.
- Conditions
- Thyroid Cancer
- Being tested
- Interdisciplinary Team-Based Approach, Usual Care Control
- Keywords
- Thyroid cancer, New diagnosis, Dedicated Nurse, Interdisciplinary team, Randomized Controlled Trial, Intervention, Supportive care
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary Team-Based ApproachOther
Also called Interdisciplinary Team-Based Approach (ITCA-ThyCa)
Three meetings will be scheduled with the oncology dedicated-nurse. First meeting: information about the physical illness; the emotional impact of being newly diagnosed with thyroid cancer; as well as surgery and its' short- and long-term consequences. Second meeting: information on radioactive iodine treatments and its associated safety precautions, nutrition and dietary considerations. Third meeting: how the cancer diagnosis can be an opportunity to make important lifestyle changes and establish new life-priorities. The dedicated nurse, in collaboration with the Department of Nursing and ENT, will develop and implement an interdisciplinary team-based approached developed for this study according to guidelines of the Programme québécois de lutte contre le cancer (PQLC).
Usual Care ControlOther
Patients in the control group will be provided with usual care, comprised of meetings with surgeons and endocrinologists. All patients in this study will be provided with an information website containing information on their cancer, treatments, and treatment side-effects.
| Study group | Role | What they receive |
|---|---|---|
| Interdisciplinary Team-Based Approach | Experimental | The delivered intervention will be to provide patients with an interdisciplinary team-based approach defined as care provided by a variety of professionals, each having their own domain of expertise, defined roles and responsibilities, who work together and meet to discuss patient needs and develop comprehensive treatment plans. Team composition will include physicians, a dedicated nurse, and allied professionals (e.g., dieticians, social workers, psychologists). The dedicated nurse will have a central integrative role in this interdisciplinary team and will provide patients with information about their illness and treatment, symptom management, emotional support, and reference to other resources when needed Receives: Other: Interdisciplinary Team-Based Approach |
| Usual Care Control Group | Other | Patients in the control group will be provided with usual care, comprised of meetings with surgeons and endocrinologists. All patients in this study will be provided with an information website containing information on their cancer, treatments, and treatment side-effects. Receives: Other: Usual Care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall quality of life
Measure: Functional Assessment of Chronic Illness Therapy-General (FACT-G)
Measured: 9 months post-randomization
Secondary outcomes (7)
Level of physical health
Measure: SF-36 Physical Health subscale
Measured: 9 months post-randomization
Level of mental health
Measure: SF-36 Mental Health subscale
Measured: 9 month post-randomization
Level of fatigue
Measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Measured: 9 months post-randomization
Level of anxiety and depression (combined)
Measure: Hospital Anxiety and Depression Scale (HADS)
Measured: 9 month post-randomization
Level of negative illness perception
Illness Perception Questionnaire - Revised (IPQ-R)
Measured: 9 month post-randomization
Level of satisfaction with care
16 questions of the NRC Picker satisfaction survey measuring patient satisfaction with care
Measured: 9 month post-randomization
Healthcare service use
Types of professionals consulted, frequency of visits, and time elapsed between referral and first consultation
Measured: Over 9 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startSep 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Principal investigator, Melissa Henry, Jewish General Hospital
- Investigators
- Melissa Henry, PhD, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994200
- Sponsor's protocol ID
- GZ-2013-10963
- Acronym
- ITCA-ThyCa
- Status last verified
- Feb 2016
- First submitted
- 19 Nov 2013
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) For Newly Diagnosed Thyroid Cancer Patients: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01994200
- Acronym / sponsor ID
- ITCA-ThyCa / GZ-2013-10963
- Conditions
- Thyroid Cancer
- Keywords
- Thyroid cancer, New diagnosis, Dedicated Nurse, Interdisciplinary team, Randomized Controlled Trial, Intervention, Supportive care
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 25 Nov 2013 (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.
While thyroid cancer is generally associated with a favourable prognosis, there is a discrepancy with how important if not traumatic its impact can be on patients. Quality of life (QoL) decreases in the year following a thyroid cancer diagnosis, constituting an optimal period for a preventive intervention. The goal of this study is to evaluate the impact of offering an interdisciplinary team-based care approach for newly diagnosed thyroid cancer patients, including a dedicated nurse who will provide important psychoeducational elements identified in previous focus group studies of thyroid cancer patients, i.e., information on: the physical illness; the emotional impact of being newly diagnosed with thyroid cancer; surgery and its' short- and long-term consequences; radioactive iodine treatments and its associated safety precautions, nutrition and dietary considerations; and how the cancer diagnosis can be an opportunity to make important lifestyle changes and establish new life-priorities.
Detailed description
The investigators will conduct a 2-arm Randomized Controlled Trial comparing an Interdisciplinary Team-Based Care Approach to usual care.
The primary research question will be: Does adding the Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) to usual care (EG) increase levels of overall QoL among newly diagnosed thyroid cancer patients, compared with those receiving usual care (UC), at 9 months post-randomization (i.e., after all of the dedicated-nurse meetings are administered) as judged by scores on the Functional Assessment of Chronic Illness Therapy-General (FACT-G)? Primary hypothesis: The EG will report higher scores of overall QoL on the FACT-G than the UC at 9 months post-randomization.
Secondary research questions: The investigators plan to evaluate ITCA-ThyCa effects on secondary outcomes such as level of: physical health (SF-36 Physical Health subscale), mental health (SF-36 Mental Health subscale), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue; FACIT-F), anxiety and depression (Hospital Anxiety and Depression Scale; HADS), and negative illness perception (Illness Perception Questionnaire - Revised (IPQ-R). The investigators also plan to explore ITCA-ThyCa effects on satisfaction with care (16 questions of the NRC Picker satisfaction survey measuring patient satisfaction with care) and healthcare service use (types of professionals consulted, frequency of visits, and time elapsed between referral and first consultation). Hypotheses: The EG will report a higher level of physical and mental health on the SF-Physical and Mental Health subscales, respectively; and a lower level of fatigue on the FACIT-F, anxiety and depression on the HADS, and negative illness perception on the IPQ-R; compared with the UC at 9 months post-randomization.
All of the abovementioned changes will be present throughout the treatment, namely at 7-10 days and 5 months post-randomization (i.e., immediately after each of the meetings planned with the dedicated nurse).
All of the abovementioned changes will persist at 12 months post-randomization (i.e., corresponding to 6 months after all anti-cancer treatments are completed and 3 months after all dedicated-nurse meetings have been administered).
Feasibility and acceptability (9 first months of the trial):
The investigators plan on testing the feasibility and acceptability of the 2-arm RCT of ITCA-ThyCa during the first 9 months of the trial (once the investigators start recruiting, after the first 3-6 months dedicated to hiring our personnel and developing the manual of our approach). During this phase, the investigators will aim to address the following research questions:
- Can the investigators recruit a sufficient number of patients (i.e., a minimum of 60 patients over 6 months or 10/month) and retain a sufficient proportion of thyroid cancer patients (i.e., at least 80% at 7-10 days, 5 months or 9 months post-randomization) in both trial arms?
- Is ITCA-ThyCa acceptable to at least 80% of EG thyroid cancer patients? Secondary pilot study questions
- Which evaluation time should be primary post-randomization, based on an acceptable retention rate of 80%?
- What variance estimates can be used to inform calculation of sample size for the full study?
If the design remains the same following this pilot, the investigators aim to roll in the pilot data in the full trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interdisciplinary Team-Based Approach | Experimental | Other: Interdisciplinary Team-Based ApproachThe delivered intervention will be to provide patients with an interdisciplinary team-based approach defined as care provided by a variety of professionals, each having their own domain of expertise, defined roles and responsibilities, who work together and meet to discuss patient needs and develop comprehensive treatment plans. Team composition will include physicians, a dedicated nurse, and allied professionals (e.g., dieticians, social workers, psychologists). The dedicated nurse will have a central integrative role in this interdisciplinary team and will provide patients with information about their illness and treatment, symptom management, emotional support, and reference to other resources when needed |
| Usual Care Control Group | Other | Other: Usual Care ControlPatients in the control group will be provided with usual care, comprised of meetings with surgeons and endocrinologists. All patients in this study will be provided with an information website containing information on their cancer, treatments, and treatment side-effects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system);
- Willing to participate in the EG meetings;
- >18 years;
- Alert and capable of giving free and informed consent;
- Able to speak and read English or French.
Key exclusion criteria (2 listed)
- Anaplastic thyroid cancer;
- Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment.
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 |
|---|---|---|
| Interdisciplinary Team-Based ApproachAlso: Interdisciplinary Team-Based Approach (ITCA-ThyCa)Three meetings will be scheduled with the oncology dedicated-nurse. First meeting: information about the physical illness; the emotional impact of being newly diagnosed with thyroid cancer; as well as surgery and its' short- and long-term consequences. Second meeting: information on radioactive iodine treatments and its associated safety precautions, nutrition and dietary considerations. Third meeting: how the cancer diagnosis can be an opportunity to make important lifestyle changes and establish new life-priorities. The dedicated nurse, in collaboration with the Department of Nursing and ENT, will develop and implement an interdisciplinary team-based approached developed for this study according to guidelines of the Programme québécois de lutte contre le cancer (PQLC). | Other | Interdisciplinary Team-Based Approach |
| Usual Care ControlPatients in the control group will be provided with usual care, comprised of meetings with surgeons and endocrinologists. All patients in this study will be provided with an information website containing information on their cancer, treatments, and treatment side-effects. | Other | Usual Care Control Group |
Primary outcome
Overall quality of life
Time frame: 9 months post-randomization
Measure: Functional Assessment of Chronic Illness Therapy-General (FACT-G)
7 secondary outcomes
Level of physical health
Time frame: 9 months post-randomization
Level of mental health
Time frame: 9 month post-randomization
Level of fatigue
Time frame: 9 months post-randomization
Level of anxiety and depression (combined)
Time frame: 9 month post-randomization
Level of negative illness perception
Time frame: 9 month post-randomization
Level of satisfaction with care
Time frame: 9 month post-randomization
Healthcare service use
Time frame: Over 9 months post-randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
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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.
Melissa Henry, PhD principal investigator
Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Interdisciplinary Team-Based Approach in people with Thyroid Cancer, 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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 23 Feb 2016. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Overall quality of life (time frame: 9 months post-randomization). 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 23 Feb 2016.