Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients randomized to this arm will receive language-concordant patient navigation from a trained navigator, over the phone and via text and email, to assist patients to complete colonoscopy to screen for colorectal cancer.

Participants randomized to this arm will receive an educational brochure about the importance of colonoscopy to screen for colorectal cancer.

Patients will receive navigation from a trained lay navigator at a community-based nonprofit organization that supports access to high quality healthcare. The patient navigator will work with patients to schedule their colonoscopy and identify, explore, and overcome barriers. They will educate patients about the colonoscopy procedure and preparation, provide resources, and coach and motivate patients.

Patient Navigation

Usual Care Control

Allison M Cole, MD, MPH

This study aims to test the effectiveness of a patient navigation program for increasing colonoscopy completion for colorectal cancer screening, among rural populations. The study will partner with geographically disparate primary care organizations to recruit patients aged 45-75 to the study. The patient navigation program will be delivered through a community organization. This project is critical in advancing our knowledge of the effectiveness of patient navigation for increasing colonoscopy in this patient population as well as for understanding factors that can support long term implementation and sustainability of effective interventions.

Colorectal cancer (CRC) is a leading cause of cancer death in the United States and its burden is greater in rural and low-income communities. Failure to complete recommended colonoscopy contributes to later-stage CRC diagnosis and worse CRC outcomes, which means timely and successful colonoscopy is a key opportunity to reduce CRC mortality. Using a Type 1 Hybrid Implementation-Effectiveness design, we will randomize 480-600 subjects from 6-8 primary care clinical organizations in a randomized controlled trial (RCT) to accomplish the following:

* Test the effectiveness of a patient navigation program delivered by a community-based organization, for increasing colonoscopy completion rates for colorectal cancer screening among rural patients.
* Assess implementation and sustainability of the patient navigation program from the perspectives of both community and clinical stakeholders.

Colonoscopy Outreach for Rural Communities Aim 2

National Cancer Institute (NCI)

University of Washington

Associate Professor, School of Medicine

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

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

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.

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).

Interdisciplinary Team-Based Approach

Melissa Henry, PhD

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.

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.

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

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

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

Measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

Measure: Hospital Anxiety and Depression Scale (HADS)

Illness Perception Questionnaire - Revised (IPQ-R)

16 questions of the NRC Picker satisfaction survey measuring patient satisfaction with care

Types of professionals consulted, frequency of visits, and time elapsed between referral and first consultation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Colonoscopy Outreach for Rural Communities Aim 2	NCT05453630	Colorectal Canc...	Patient Navigat... Usual Care Cont...	45 Years - 915 Months	University of Washington
Colonoscopy Outreach for Rural Communities Aim 2	NCT05453630	Colorectal Canc...	Patient Navigat... Usual Care Cont...	45 Years - 915 Months	University of Washington
Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients	NCT01994200	Thyroid Cancer	Interdisciplina... Usual Care Cont...	18 Years -	Jewish General Hospital

Spots Global Cancer Trial Database for usual care control