Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients

Thyroid Cancer Clinical Trial

— ITCA-ThyCa  

Official title:

Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) For Newly Diagnosed Thyroid Cancer Patients: Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01994200
• Other study ID #: GZ-2013-10963
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: November 19, 2013
• Last updated: February 22, 2016
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: February 2016
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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. 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.

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:

1. 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?

2. Is ITCA-ThyCa acceptable to at least 80% of EG thyroid cancer patients? Secondary pilot study questions

3. Which evaluation time should be primary post-randomization, based on an acceptable retention rate of 80%?

4. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Other:
• Interdisciplinary Team-Based Approach
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 Control
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.

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Jewish General Hospital	Genzyme, a Sanofi Company

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall quality of life	Measure: Functional Assessment of Chronic Illness Therapy-General (FACT-G)	9 months post-randomization	No
Secondary	Level of physical health	Measure: SF-36 Physical Health subscale	9 months post-randomization	No
Secondary	Level of mental health	Measure: SF-36 Mental Health subscale	9 month post-randomization	No
Secondary	Level of fatigue	Measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)	9 months post-randomization	No
Secondary	Level of anxiety and depression (combined)	Measure: Hospital Anxiety and Depression Scale (HADS)	9 month post-randomization	No
Secondary	Level of negative illness perception	Illness Perception Questionnaire - Revised (IPQ-R)	9 month post-randomization	No
Secondary	Level of satisfaction with care	16 questions of the NRC Picker satisfaction survey measuring patient satisfaction with care	9 month post-randomization	No
Secondary	Healthcare service use	Types of professionals consulted, frequency of visits, and time elapsed between referral and first consultation	Over 9 months post-randomization	No