SNAP Tool for Head and Neck Cancer

(SNAP Trial)

Overseen By Katherine R Sterba, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Non-English speakers, Cognitive impairment, Others

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

Compensation: Varies

Number of Visits: 9

352 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals who have had head and neck cancer, along with their caregivers, by testing a new support tool called the Survivorship Needs Assessment Planning (SNAP) tool. SNAP provides personalized care planning and a mobile app to manage symptoms and reduce caregiver stress after cancer treatment. Participants include those currently receiving radiation for head and neck cancer and their caregivers who are willing to join. The study will compare SNAP's effects to usual care, focusing on improving quality of life and reducing anxiety and depression in both patients and caregivers. As an unphased trial, this study presents a unique opportunity to contribute to research that could enhance support for cancer survivors and their caregivers.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to consult with the trial coordinators or your healthcare provider for guidance.

What prior data suggests that the SNAP tool is safe for head and neck cancer survivors and their caregivers?

Research has shown that the Survivorship Needs Assessment Planning (SNAP) tool was created to support head and neck cancer survivors and their caregivers. This tool includes sessions and a mobile app to assist them after treatment. Although specific safety data is not provided, the SNAP tool is a behavioral intervention. It focuses on planning and support rather than medication or invasive procedures, which usually means a lower risk of physical side effects.

In studies, participants have well-received similar tools. Since SNAP involves assessments, setting goals, and creating personalized care plans, it is designed to help rather than harm. Participants in past studies did not report significant negative effects from using the tool itself. This suggests that the SNAP tool is likely safe for managing care after cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SNAP tool for head and neck cancer because it offers a personalized approach to survivorship care. Unlike the standard follow-up visits where patients and caregivers mainly receive printed materials, the SNAP tool involves a two-session intervention that actively assesses the needs of both survivors and their caregivers. It creates a tailored care plan with goal-setting discussions and provides referrals for unmet needs. Additionally, the inclusion of a supportive mobile app extends care beyond the clinic, helping patients and caregivers for six weeks after the sessions. This approach could lead to more comprehensive and effective support during the critical post-treatment phase.

What evidence suggests that the SNAP tool is effective for head and neck cancer survivors and their caregivers?

Research has shown that the SNAP tool, which participants in this trial may receive, can assist head and neck cancer survivors and their caregivers in managing symptoms and reducing caregiver stress. Studies have found that SNAP, which includes a needs check and a personalized care plan, improves how patients and caregivers handle post-treatment challenges. Early results suggest that SNAP also reduces anxiety and depression and increases the likelihood of receiving recommended care. The tool's supportive mobile app further addresses unmet needs and boosts confidence in health management. Overall, SNAP aims to ease life after cancer treatment for both patients and their caregivers. ^{1 2 3 4 5}

Who Is on the Research Team?

Katherine R Sterba, PhD, MPH

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults over 18 with non-metastatic head and neck cancer (various types) who are currently undergoing radiation, possibly alongside surgery or chemotherapy. They must aim to cure their cancer and be able to nominate a caregiver willing to participate.

Inclusion Criteria

I am older than 18 years.

I can name a caregiver willing to participate with me.

I am undergoing radiation (possibly with surgery/chemo) aimed at curing my cancer.

Exclusion Criteria

Patients who do not read/understand English

I am unable to complete interviews due to cognitive impairment.

I don't have a serious second cancer, except for certain less severe types.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants complete radiation treatment, during which the SNAP intervention begins with a caregiver module

1-2 weeks

1 visit (in-person)

SNAP Intervention

Participants in the SNAP group receive two intervention sessions with needs assessment, tailored care plan, and supportive mobile app

3 months

2 visits (in-person), ongoing app engagement

Follow-up

Participants are monitored for outcomes such as symptom severity, caregiver burden, and psychological distress

9 months

Assessments at baseline, 6 months, and 9 months

What Are the Treatments Tested in This Trial?

Interventions

• Survivorship Needs Assessment Planning (SNAP) tool

Trial Overview The study tests the SNAP tool, which includes assessment sessions, a care plan, and a mobile app support post-radiation treatment. It compares SNAP's impact on symptom severity and caregiver burden against usual care over 6 to 9 months.

How Is the Trial Designed?

Group I: SNAP Experimental Treatment 1 Intervention

Caregiver- Survivor Dyads in this group will receive a two-session intervention spanning 3 months, with a caregiver module within 1-2 weeks of the end of RT and a dyadic module at 3 months. Each session will include a needs- assessment, a tailored care plan with a goal setting discussion, and referrals for unmet needs. Each session follows with a supportive mobile app for 6 weeks.

Group II: Usual Care Active Control 1 Intervention

Caregiver- Survivor Dyads in this group will receive routine follow-up care in the HNC clinic. Current standard of care is an Advanced Practice Provider (Physician Assistant or Nurse Practitioner)-delivered survivorship visit after treatment. This visit will take place according to UC in the clinic. UC dyads will also receive printed caregiving and survivorship materials.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A study involving 285 Chinese head and neck cancer survivors identified significant unmet supportive care needs, particularly in health system access and information, highlighting gaps in healthcare services for these patients.

Qualitative interviews with 53 participants revealed five key categories of unmet needs, including physical, psychological, and sexuality-related issues, suggesting that tailored care and improved communication are essential for better support of HNC survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mixed-Methods Study of Unmet Supportive Care Needs Among Head and Neck Cancer Survivors. So, WKW., Wong, CL., Choi, KC., et al.[2020]

The SNAP tool, used by 25 head and neck cancer survivor-caregiver dyads, was found to be highly acceptable and effective in creating tailored care plans, leading to significant improvements in psychosocial outcomes such as reduced depression and increased survivorship knowledge over a 6-week period.

Participants reported high satisfaction with the SNAP sessions, which effectively consolidated complex medical information and focused on caregiver well-being, indicating that technology-enabled care planning can successfully address the dynamic needs of cancer survivors and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a survivorship needs assessment planning tool for head and neck cancer survivor-caregiver dyads. Sterba, KR., Armeson, K., Zapka, J., et al.[2020]

The study identified key post-treatment challenges for head and neck cancer survivors, caregivers, and healthcare providers, emphasizing the need for a comprehensive survivorship needs assessment tool (SNAP) to address physical, emotional, and social issues.

Participants found the SNAP tool acceptable and feasible, with over 75% expressing comfort using it on a tablet, indicating that technology can effectively support personalized survivorship care plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a survivorship needs assessment planning tool for head and neck cancer survivors and their caregivers: a preliminary study. Sterba, KR., Zapka, J., LaPelle, N., et al.[2018]

The Survivor Unmet Needs Survey (SF-SUNS) demonstrated fair to good test-retest reliability in assessing the needs of lymphoma survivors, with 77% of items showing reliability scores between 0.45 and 0.74.

The SF-SUNS also exhibited high internal consistency, with Cronbach's alpha scores of 0.92 at baseline and 0.95 after 5 days, indicating it is a reliable tool for identifying the changing needs of cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test-Retest Reliability of the Short-Form Survivor Unmet Needs Survey. Taylor, K., Bulsara, M., Monterosso, L.[2022]

A total of 602 head and neck cancer survivors provided patient-reported outcomes through an Internet-based survivorship care plan program, highlighting the effectiveness of this approach in gathering valuable data.

The most common treatment-related toxicities reported were difficulty swallowing (61.5%) and changes in skin color/texture (49.7%), indicating that these issues, along with fatigue, are significant concerns that need to be addressed in survivorship care planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in head and neck cancer: prospective multi-institutional patient-reported toxicity. Peach, MS., Trifiletti, DM., Vachani, C., et al.[2022]

A review of six studies identified five needs assessment tools for cancer survivors post-treatment, but none adequately covered all areas of unmet needs or met all criteria for validity and reliability.

The Survivor Unmet Needs Survey (SUNS) was found to have the strongest psychometric properties among the tools assessed, highlighting a gap in empirical evidence for effective needs assessment in clinical settings for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A rapid review of needs assessment tools for post-treatment cancer survivors. Jiao, M., Hall, AE., Nolte, L., et al.[2022]

The implementation of the electronic Patient-Reported Outcome Measure (PROM) 'OncoFunction' in head and neck cancer patients showed high feasibility, with 846 patients completing the PROM during 2,833 out of 3,610 visits (78.5%).

The latest version of 'OncoFunction' significantly reduced errors and time required for use, enhancing the efficiency of data collection and improving patient follow-up care by providing a comprehensive view of their health-related quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obtaining Patient-Reported Outcomes Electronically With "OncoFunction" in Head and Neck Cancer Patients During Aftercare. Zebralla, V., Müller, J., Wald, T., et al.[2020]

A systematic review identified 14 measures for assessing unmet needs in head and neck cancer (HNC) patients, with three measures (Patient Concerns Inventory, Needs Assessment for Advanced Cancer Patients, and James Supportive Care Screening) showing excellent content validity.

The Patient Concerns Inventory (PCI) is recommended for use in HNC settings due to its strong content validity, which is crucial for understanding and addressing the specific needs of patients throughout their cancer journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content comparison of unmet needs self-report measures used in patients with head and neck cancer: A systematic review. Shunmugasundaram, C., Rutherford, C., Butow, PN., et al.[2020]

The Head and Neck Survivorship Tool (HN-STAR) is an electronic platform designed to enhance care for head and neck cancer survivors by integrating patient-reported outcomes into a clinical decision support tool, which helps create personalized survivorship care plans.

Feedback from HCI experts, nurse practitioners, and cancer survivors led to significant improvements in HN-STAR's usability, focusing on user interface design, assessment completion ease, and overall efficiency during clinic visits, ensuring the tool is both user-friendly and clinically relevant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating Multiple Perspectives Into the Development of an Electronic Survivorship Platform for Head and Neck Cancer. Salz, T., Schnall, RB., McCabe, MS., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5671886/

Development of a Survivorship Needs Assessment ... Development of a Survivorship Needs Assessment Planning Tool for Head and Neck Cancer Survivors and Their Caregivers: A Preliminary Study.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05811936

The SNAP Tool for Head and Neck Cancer Survivor ... Each session follows with a supportive mobile app for 6 weeks. Intervention/Treatment, Behavioral : Survivorship Needs Assessment Planning (SNAP) tool.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30645719/

Evaluation of a survivorship needs assessment planning tool ... The SNAP tool is an innovative technology-based survivor-centered strategy to assess and manage needs in HNC survivors and caregivers.

4. cancer.gov cancer.gov/clinicaltrials/NCT05811936

Evaluation of the Survivorship Needs Assessment ... This clinical trial evaluates the Survivorship Needs Assessment Planning (SNAP) tool for improving caregiver burden and symptom management among head and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772906023000195

Survivorship care in head neck cancer Evaluation of a survivorship needs assessment planning tool for head and neck cancer survivor-caregiver dyads. J Cancer Surviv, 13 (1) (2019 Feb), pp. 117 ...