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

Trial Summary

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 data supports the effectiveness of the SNAP tool treatment for head and neck cancer?

The SNAP tool for head and neck cancer is being tested for its acceptability and feasibility, focusing on improving the care of cancer survivors by addressing their needs after treatment. While there is no direct evidence of its effectiveness yet, similar tools like the Survivor Unmet Needs Survey have shown strong properties in assessing the needs of cancer survivors, suggesting potential benefits. ^{1 2 3 4 5}

Is the SNAP tool safe for use in humans?

The studies on the SNAP tool for head and neck cancer focus on its acceptability and feasibility, but they do not provide specific safety data. However, there are no reports of harm or adverse effects, suggesting it is generally safe for use. ^{3 4 5 6 7}

How is the SNAP tool treatment different from other treatments for head and neck cancer?

The SNAP tool is unique because it focuses on assessing and planning for the specific needs of head and neck cancer survivors and their caregivers, rather than directly treating the cancer itself. It aims to improve the quality of life by addressing psychosocial challenges and unmet needs after cancer treatment. ^{3 4 5 8 9}

What is the purpose of this trial?

In this randomized behavioral intervention, head and neck cancer (HNC) survivors and their caregivers (N=176 HNC survivor-caregiver dyads) will be randomized to either Survivorship Needs Assessment Planning (SNAP) or Usual Care (UC) groups to examine the effects of SNAP on outcomes. SNAP includes two sessions with a needs assessment and tailored care plan and a supportive mobile app after completion of radiation to promote uptake of recommended medical and supportive care. The study aims to evaluate the effects of SNAP on symptom severity in patients and caregiver burden in caregivers. Secondary outcomes include psychological distress (anxiety and depression), healthcare utilization (receipt of recommended care) and unmet needs and self-efficacy in HNC survivor-caregiver dyads. Participants will complete surveys at baseline, 6 months, and 9 months post randomization with validated PROMs, and receive intervention modules at the end of radiation and month 3. Participants in the SNAP group will also receive mobile app support.

Research Team

Katherine R Sterba, PhD, MPH

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A rapid review of needs assessment tools for post-treatment cancer survivors. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Test-Retest Reliability of the Short-Form Survivor Unmet Needs Survey. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Incorporating Multiple Perspectives Into the Development of an Electronic Survivorship Platform for Head and Neck Cancer. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a survivorship needs assessment planning tool for head and neck cancer survivor-caregiver dyads. [2020]

5. United States 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. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Obtaining Patient-Reported Outcomes Electronically With "OncoFunction" in Head and Neck Cancer Patients During Aftercare. [2020]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in head and neck cancer: prospective multi-institutional patient-reported toxicity. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Mixed-Methods Study of Unmet Supportive Care Needs Among Head and Neck Cancer Survivors. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Content comparison of unmet needs self-report measures used in patients with head and neck cancer: A systematic review. [2020]