- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01994200
Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients (ITCA-ThyCa)
Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) For Newly Diagnosed Thyroid Cancer Patients: Randomized Controlled Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Luoghi di studio
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Quebec
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Montreal, Quebec, Canada, H3T 1E8
- Jewish General Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Interdisciplinary Team-Based Approach
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
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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).
Altri nomi:
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Altro: Usual Care Control Group
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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Overall quality of life
Lasso di tempo: 9 months post-randomization
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Measure: Functional Assessment of Chronic Illness Therapy-General (FACT-G)
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9 months post-randomization
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Level of physical health
Lasso di tempo: 9 months post-randomization
|
Measure: SF-36 Physical Health subscale
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9 months post-randomization
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Level of mental health
Lasso di tempo: 9 month post-randomization
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Measure: SF-36 Mental Health subscale
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9 month post-randomization
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Level of fatigue
Lasso di tempo: 9 months post-randomization
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Measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
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9 months post-randomization
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Level of anxiety and depression (combined)
Lasso di tempo: 9 month post-randomization
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Measure: Hospital Anxiety and Depression Scale (HADS)
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9 month post-randomization
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Level of negative illness perception
Lasso di tempo: 9 month post-randomization
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Illness Perception Questionnaire - Revised (IPQ-R)
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9 month post-randomization
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Level of satisfaction with care
Lasso di tempo: 9 month post-randomization
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16 questions of the NRC Picker satisfaction survey measuring patient satisfaction with care
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9 month post-randomization
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Healthcare service use
Lasso di tempo: Over 9 months post-randomization
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Types of professionals consulted, frequency of visits, and time elapsed between referral and first consultation
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Over 9 months post-randomization
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Melissa Henry, PhD, Jewish General Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GZ-2013-10963
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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