NCT01994200

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

November 19, 2013

Last Update Submit

February 22, 2016

Conditions

Thyroid Cancer

Keywords

Thyroid cancerNew diagnosisDedicated NurseInterdisciplinary teamRandomized Controlled TrialInterventionSupportive care

Outcome Measures

Primary Outcomes (1)

  • Overall quality of life

    Measure: Functional Assessment of Chronic Illness Therapy-General (FACT-G)

    9 months post-randomization

Secondary Outcomes (7)

  • Level of physical health

    9 months post-randomization

  • Level of mental health

    9 month post-randomization

  • Level of fatigue

    9 months post-randomization

  • Level of anxiety and depression (combined)

    9 month post-randomization

  • Level of negative illness perception

    9 month post-randomization

  • +2 more secondary outcomes

Study Arms (2)

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

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.

Other: Usual Care Control

Interventions

Interdisciplinary Team-Based ApproachOTHER

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).

Also known as: Interdisciplinary Team-Based Approach (ITCA-ThyCa)
Interdisciplinary Team-Based Approach
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.

Usual Care Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E8, Canada

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Melissa Henry, PhD

    Jewish General Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor and Psychologist

Study Record Dates

First Submitted

November 19, 2013

First Posted

November 25, 2013

Study Start

September 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

CA(1)