CARES Intervention for Lung and Head & Neck Cancers

Recruiting at 13 trial locations

Overseen By Tatiana Gerena, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Children, Non-English/Spanish speakers, Other cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 6 months

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the CARES intervention can help rural cancer patients start and complete their treatment more quickly. It focuses on individuals with specific solid tumors, such as lung, head, neck, and several other cancers. Participants will receive either usual care or the CARES intervention, which includes up to 10 sessions of navigation and counseling over six months. Eligible participants have been diagnosed with certain cancers and live in rural, underserved areas. As an unphased trial, this study provides a unique opportunity for patients to access potentially beneficial support services tailored to their needs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CARES intervention is safe?

Research has shown that the CARES program, which includes counseling and guidance sessions, is generally manageable for participants. Studies have found that programs like CARES can improve outcomes for lung cancer patients without causing major side effects. Thus, the CARES program is considered safe for participants. Prospective participants in a CARES trial can expect the sessions to support them through treatment, with no reports of harmful effects from the program itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CARES Intervention because it offers a personalized support approach for patients with lung and head & neck cancers, which is quite different from the usual care options. Unlike standard treatments that might focus primarily on medical procedures like surgery, chemotherapy, or radiation, CARES provides up to 10 navigation and 10 counseling sessions tailored to key transition points in a patient's treatment journey. These sessions, delivered by trained oncology nurse navigators and counselors, aim to improve the quality of care and patient outcomes by providing emotional and practical support. This approach could enhance patient experiences and potentially lead to better treatment adherence and outcomes, making it a promising addition to current cancer care strategies.

What evidence suggests that the CARES Intervention is effective for improving treatment timelines in cancer patients?

Research has shown that the CARES Intervention, which includes guidance and counseling sessions, helps cancer patients by reducing stress and improving coping abilities. In this trial, participants will receive either the CARES Intervention or usual care. Patients with head-and-neck and lung cancers, who often lack resources, have experienced these benefits. Studies on similar step-by-step care programs suggest they can make cancer treatment easier to manage and more accessible. This approach aims to support patients both emotionally and practically, potentially leading to better treatment schedules and outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Evelinn Borrayo

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

Adults over 18 with lung or head and neck cancer, who speak English or Spanish, live in rural areas with limited healthcare access, and will receive standard treatments. They must be diagnosed at specific stages and treated at certain Colorado centers. Excluded are those with other primary cancers, hearing loss without aids, already started treatment, decisionally-challenged individuals or those not treated at the specified sites.

Inclusion Criteria

Receives cancer treatment at University of Colorado Hospital (UCH), SCL-St. Mary's Medical Center, or Rocky Mountain Cancer Centers (RMCC) in Pueblo, CO

Resides in any of the rural counties served by one of the collaborating sites with Rural-Urban Continuum Codes (RUCC) codes 4-9

Provision to sign and date the consent form

Exclusion Criteria

I am under 18 years old.

Likely inability to track the individual over time

Individuals from vulnerable populations

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CARES intervention or usual care over a 6-month period, including navigation and counseling sessions

6 months

Up to 10 navigation and 10 counseling sessions (in-person, virtual, or phone)

Follow-up

Participants are monitored for quality of care and patient-reported outcomes

6 months

Surveys at baseline, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• CARES Intervention

Trial Overview

The CARES intervention is being tested to see if it can shorten the time between diagnosis and start of treatment as well as the time to complete treatment for patients with Lung Cancer and Head and Neck Cancer in rural settings.

How Is the Trial Designed?

Group I: Usual Care Active Control 1 Intervention

All participants will complete surveys to assess Quality of Care and Patient Reported Outcomes. Patients will receive a standardized list of resources.

Group II: CARES Intervention Active Control 1 Intervention

All participants will complete surveys to assess Quality of Care and Patient Reported outcomes at baseline, 3 months and 6 months. The CARES intervention will include a maximum of 10 navigation and 10 counseling sessions delivered over approximately a 6- month period delivered by oncology nurse navigators and master's level counselors. Sessions will be scheduled to correspond with key transition points during treatment and may be held in person, virtually, or by phone.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Head and neck cancer patients experience significant quality of life disruptions due to unmet support needs during and after treatment, particularly related to coping with permanent side effects and psychological stressors like depression and anxiety.

Patients reported feeling isolated after treatment due to the loss of access to supportive hospital environments, highlighting the importance of professional and personal networks for coping during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I have quality of life…but…": Exploring support needs important to quality of life in head and neck cancer. Moore, KA., Ford, PJ., Farah, CS.[2022]

The EASE study demonstrated that a tailored telephone-based coping and stress management intervention is feasible and acceptable for head and neck cancer patients, with high satisfaction reported by participants and counselors.

While the small sample size (24 participants) limits definitive conclusions about efficacy, preliminary results suggest that the EASE intervention may help reduce the negative emotional and physical impacts of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of EASE: a psychosocial program to improve symptom management in head and neck cancer patients. Kilbourn, KM., Anderson, D., Costenaro, A., et al.[2022]

Stepped care (SC) significantly reduced psychological distress in head and neck cancer and lung cancer patients compared to care-as-usual, with a recovery rate of 55% in the SC group versus 29% in the CAU group after treatment.

The SC approach was particularly effective for patients with existing depressive or anxiety disorders, indicating that tailored psychological support can enhance recovery outcomes in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepped care targeting psychological distress in head and neck cancer and lung cancer patients: a randomized, controlled trial. Krebber, AM., Jansen, F., Witte, BI., et al.[2020]

Patients treated for head and neck cancer often experience significant functional impairments that can greatly affect their quality of life, highlighting the need for intensive post-treatment follow-up.

There are currently no clear guidelines on the frequency of follow-up visits, but these visits are crucial for early detection of issues and initiating rehabilitation to optimize patient recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring and Evaluation of Late Functional Outcome in Post-treatment Follow-Up in Clinical Routine Setting. Zebralla, V., Meuret, S., Wiegand, S.[2023]

In a study involving head and neck cancer patients, speech and eating were identified as the most significant factors affecting overall quality of life, with speech having the strongest impact.

The study used logistic regression to analyze responses from a disease-specific quality of life survey, highlighting the importance of addressing speech and eating issues in treatment planning for better patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing head and neck cancer patient outcome domains. Karnell, LH., Funk, GF., Hoffman, HT.[2019]

A new set of outcome indicators for lung cancer care was developed through a systematic process involving literature review and expert evaluation, focusing on survival, recovery, and quality of life for patients.

The study analyzed data from 5922 lung cancer patients across six hospitals, revealing variations in care quality and outcomes, which can help compare hospital performance and improve patient information regarding treatment results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Care for Outcomes': systematic development of a set of outcome indicators to improve patient-relevant outcomes for patients with lung cancer. Cramer-van der Welle, CM., van Loenhout, L., van den Borne, BE., et al.[2021]

A study involving 33 participants, including 20 head and neck cancer survivors and 13 healthcare providers, highlighted the need for tailored supportive care interventions for HNC survivors, as they face unique and persistent symptoms affecting their quality of life.

Participants emphasized the importance of offering these interventions throughout the treatment and survivorship journey, with a preference for group-based support, while also recognizing that not all survivors may benefit from this format due to potential social comparison and anxiety issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations for developing supportive care interventions for survivors of head and neck cancer: A qualitative study. Oswald, LB., Arredondo, B., Geiss, C., et al.[2023]

A significant 70.3% of informal caregivers for head and neck cancer patients reported at least one unmet supportive care need at the start of the study, primarily related to healthcare and illness, highlighting the high burden they face.

Despite a decrease in unmet needs over a 2-year follow-up, 28.3% of caregivers still reported unmet needs, particularly those caring for patients with advanced disease or severe comorbidities, indicating a need for ongoing support and resources for caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unmet supportive care needs among informal caregivers of patients with head and neck cancer in the first 2 years after diagnosis and treatment: a prospective cohort study. van Hof, KS., Hoesseini, A., Dorr, MC., et al.[2023]

Outcomes research is crucial for understanding the effectiveness of healthcare practices, especially in head and neck cancer (HNCA), as it helps inform better health decisions and practices during healthcare reform.

The article reviews recent studies on HNCA that focus on treatment efficacy, survival rates, complications, and quality of life, highlighting the importance of patient-centered outcomes in evaluating healthcare interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes measurement in patients with head and neck cancer. Gourin, CG.[2021]

The dyadic survivorship care planning (SCP) intervention, which involved a one-session care plan and follow-up, was found to be acceptable to head and neck cancer survivors and their caregivers, with over 80% positive ratings on session length and content.

However, the SCP intervention did not lead to significant improvements in depression, unmet needs, or caregiver burden after 6 months compared to usual care, indicating that while the approach was well-received, it was ineffective in enhancing the outcomes for the dyads involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial to evaluate a survivorship care planning intervention for head and neck cancer survivor-caregiver dyads. Sterba, KR., Armeson, K., Zapka, J., et al.[2022]

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