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SNAP Tool for Head and Neck Cancer (SNAP Trial)

N/A

Recruiting

Led By Katherine R Sterba, PhD, MPH

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up caregivers will be assessed at baseline, 6 weeks, 6 months, 9 months

Awards & highlights

SNAP Trial Summary

This trial will assess a tailored care plan (SNAP) to help head and neck cancer survivors and their caregivers manage symptoms, ease burden and receive recommended medical/supportive care.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves a supportive intervention rather than medication, traditional side effects are not expected. However, participants may experience varying levels of psychological distress like anxiety or depression.

SNAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ caregivers will be assessed at baseline, 6 weeks, 6 months, 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~caregivers will be assessed at baseline, 6 weeks, 6 months, 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and caregivers will be assessed at baseline, 6 weeks, 6 months, 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in Caregiver Burden at 9 months post randomization

Change from baseline in Symptom Severity in head and neck cancer survivors at 9 months post randomization

Secondary outcome measures

Change from baseline in Anxiety for Caregivers at 9 months post randomization

Change from baseline in Anxiety for Survivors at 9 months post randomization

Change from baseline in Depression for Caregivers at 9 months post randomization

+6 more

SNAP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SNAPExperimental Treatment1 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 CareActive Control1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,089 Total Patients Enrolled

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,284 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,498 Total Patients Enrolled

Media Library

Survivorship Needs Assessment Planning (SNAP) tool Clinical Trial Eligibility Overview. Trial Name: NCT05811936 — N/A

Survivorship Research Study Groups: Usual Care, SNAP

Survivorship Clinical Trial 2023: Survivorship Needs Assessment Planning (SNAP) tool Highlights & Side Effects. Trial Name: NCT05811936 — N/A

Survivorship Needs Assessment Planning (SNAP) tool 2023 Treatment Timeline for Medical Study. Trial Name: NCT05811936 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment still open?

"Clinicaltrials.gov confirms that this research trial, posted on May 1st 2023 and last updated March 31st of the same year, is not currently recruiting participants. That said, there are 601 other studies actively looking for volunteers right now."

Answered by AI

What objectives are the researchers hoping to achieve with this clinical investigation?

"This trial seeks to measure the fluctuation of symptoms related to head and neck cancer in patients and their caregivers over 9 months. Caregivers' depression at baseline, 6 weeks, 6 months, and 9 month post randomization will be evaluated using PROMIS Depression- SF v1.0 form 8A while their anxiety levels will be quantified with PROMIS Short Form v1.0 - Anxiety 8a. Similarly patient's depression will also be assessed with a similar scale for accuracy of data collection."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The SNAP Tool for Head and Neck Cancer Survivor-Caregiver Dyads

Katherine Sterba 2023. "The SNAP Tool for Head and Neck Cancer Survivor-Caregiver Dyads". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05811936.