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

June 9, 2026 updated by: Katherine Sterba, Medical University of South Carolina

A Randomized Controlled Trial to Evaluate the Survivorship Needs Assessment Planning (SNAP) Tool for Head and Neck Cancer Survivor-Caregiver Dyads

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The SNAP Intervention includes two care planning modules, a caregiver visit (module I) during the end of radiation treatment and a dyad-focused (survivor and caregiver) visit (module II) at 3 months. Each SNAP module includes 3 components including: 1) an in-clinic needs assessment, 2) a tailored care plan and 3) text-based e-monitoring at home. In both modules, a care plan is generated with algorithm-triggered messages and referrals to recommended care matched to endorsed concerns. Care plans are reviewed and barriers are addressed. Referrals are finalized with an Advanced Practice Provider (APP). SNAP Participants leave with a personalized binder including the survivorship care plan and referrals. SNAP Participants use an e-monitoring App and receive twice weekly engagement prompts for 6 weeks. Usual Care (UC) participants will receive caregiver education and dyadic survivorship education visit at the end of radiation treatment and 3-months post-randomization, respectively, with printed materials from the National Cancer Institute.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
352

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Katherine R Sterba, PhD, MPH
  • Phone Number: 8438762419
  • Email: sterba@musc.edu

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
          • Katherine Sterba, PhD, MPH
          • Phone Number: 8438762419
          • Email: sterba@musc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Patient Inclusion Criteria:

  1. Age >18
  2. Stage I-IV non-metastatic HNC (i.e., lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, larynx and cutaneous cancers)
  3. Currently receiving radiation treatment (with/without surgery and/or concurrent chemotherapy) with curative intent
  4. Able to nominate caregiver, the primary support person, also interested in participating

Caregiver Inclusion Criteria:

  1. Age >18
  2. Provide care for a loved one with stage I-IV HNC
  3. Agrees to participate after being nominated

Patient Exclusion Criteria:

  1. Patients who do not read/understand English
  2. Patients who are cognitively impaired and cannot complete interviews as judged by the referring health care provider

  3. Patients concurrently diagnosed with and/or receiving treatment for a second "significant" primary cancer, except the following:

    • Excised and cured non-melanoma skin cancer
    • Carcinoma in situ of breast or cervix
    • Superficial bladder cancer
    • Stage 1 differentiated thyroid cancer that is resected or observed
    • pT1a/pT1b prostate cancer comprising <5% of resected tissue with normal prostate specific antigen (PSA) since resection
    • cT1a/cT1b prostate cancer treated with brachytherapy

Caregiver Exclusion Criteria:

  1. Inability to read or understand English
  2. Cognitively impaired and cannot complete interviews, as judged by the referring health care provider

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual Care
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.
Experimental: SNAP
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.
Behavioral: Survivorship Needs Assessment Planning (SNAP) tool
SNAP includes 2 educational survivorship modules for caregivers and survivors. There are 3 main elements: needs assessment, a tailored care plan and a mobile support app. SNAP uses pre-specified categories of needs, resources, and messaging "behind the scenes" to automate the identification, rating and management of high priority needs. Generated tailored care plans include referrals, messages and educational materials mapped to prioritized dyad-reported concerns addressing survivorship domains (diagnosis, treatment, follow-up care). Care plans and referrals are reviewed with an Advanced Practice Provider. Barriers to uptake are addressed, goal-oriented action planning is refined with brief mobile app training. Dyads receive a personalized binder with care plan, referrals, and an action plan. Dyads receive e-monitoring for 6 weeks to check in and identify barriers with algorithm-driven messaging to reinforce progress, provide further resources and encouragement.
Other Names:
  • SNAP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Caregiver Burden at 9 months post randomization
Time Frame: Caregivers will be assessed at baseline, 6 weeks, 6 months, and 9 months post randomization
Caregivers report the extent to which caregiving impacts time, responsibilities, and strain utilizing the Zarit Burden Inventory. Caregivers rate each item on a 5-point Likert scale (0=Never to 4=Always); higher scores (0-16) indicate greater burden. An increase in change from baseline to 6 week, 6 months or 9 months follow up visit would increased caregiver distress; likewise a decrease in change would indicate reduced caregiver distress. Cronbach's alphas in previous research range from 0.81-0.83.
Caregivers will be assessed at baseline, 6 weeks, 6 months, and 9 months post randomization
Change from baseline in Symptom Severity in head and neck cancer survivors at 9 months post randomization
Time Frame: Survivors will be assessed at baseline, and at 6 months and 9 months post randomization
Symptom burden in survivors will be assessed with the MD Anderson Symptom Inventory-Head and Neck Cancer Module (MDASI-HN) The MDASI -HN includes 13 core items and an additional 9 head and neck cancer module items which calculates a total score of symptom severity. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 Numeric Rating Scale, with 0 being "not present" and 10 being "as bad as you can imagine." Core items and module symptom items are averaged into a mean module severity. A higher score always indicates an increase in severity. A decrease in change from baseline to 9-month assessment indicates improvement of symptoms. Cronbach's alphas in previous research range from 0.88-0.92.
Survivors will be assessed at baseline, and at 6 months and 9 months post randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Depression for Caregivers at 9 months post randomization
Time Frame: Caregivers will be assessed at baseline, 6 months and 9 months
Depression in Caregivers will be assessed with the PROMIS Depression- SF v1.0 form 8A. Respondents are asked how often in the past 7 days they have experienced specific depression symptoms, using a 5-point ordinal rating scale whereby 1= "Never," 5="Always." A higher score indicates higher depression. Raw score totals are converted to an item response theory-based T-scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10 with a range of 38.2 to 81.3. Therefore, a person with a T-score of 40 is one SD below the mean. A decrease in change from baseline to 9 month assessment indicates reduced depression. Cronbach's alphas in previous research = 0.97 for anxiety and depression.
Caregivers will be assessed at baseline, 6 months and 9 months
Change from baseline in Anxiety for Caregivers at 9 months post randomization
Time Frame: Caregivers will be assessed at baseline, 6 months and 9 months
Anxiety in Caregivers will be assessed with the PROMIS Short Form v1.0 - Anxiety 8a. Respondents are asked how often in the past 7 days they have experienced specific anxiety symptoms, using a 5-point ordinal rating scale whereby 1= "Never," 5="Always." A higher score indicates higher anxiety. Raw score totals are converted to an item response theory-based T-scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10 with a range of 38.2 to 81.3. Therefore, a person with a T-score of 40 is one SD below the mean. A decrease in change from baseline to 9 month assessment indicates reduced anxiety. Cronbach's alphas in previous research = 0.97 for anxiety and depression.
Caregivers will be assessed at baseline, 6 months and 9 months
Change from baseline in Depression for Survivors at 9 months post randomization
Time Frame: Survivors will be assessed at baseline, 6 months and 9 months
Depression in Survivors will be assessed with the PROMIS Depression- SF v1.0 form 8A . Respondents are asked how often in the past 7 days they have experienced specific depression symptoms, using a 5-point ordinal rating scale whereby 1= "Never," 5="Always." A higher score indicates higher depression. Raw score totals are converted to an item response theory-based T-scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10 with a range of 38.2 to 81.3. Therefore, a person with a T-score of 40 is one SD below the mean. A decrease in change from baseline to 9 month assessment indicates reduced depression. Cronbach's alphas in previous research = 0.97 for anxiety and depression.
Survivors will be assessed at baseline, 6 months and 9 months
Change from baseline in Anxiety for Survivors at 9 months post randomization
Time Frame: Survivors will be assessed at baseline, 6 months and 9 months
Anxiety in Survivors will be assessed with the PROMIS Short Form v1.0 - Anxiety 8a. Respondents are asked how often in the past 7 days they have experienced specific anxiety symptoms, using a 5-point ordinal rating scale whereby 1= "Never," 5="Always." A higher score indicates higher anxiety. Raw score totals are converted to an item response theory-based T-scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10 with a range of 38.2 to 81.3. Therefore, a person with a T-score of 40 is one SD below the mean. A decrease in change from baseline to 9 month assessment indicates reduced anxiety. Cronbach's alphas in previous research = 0.97 for anxiety and depression.
Survivors will be assessed at baseline, 6 months and 9 months
Change in Healthcare Utilization (HCU)/ receipt of recommended care at 6 months in head and neck cancer survivor-caregiver dyads.
Time Frame: Dyads (Survivor & Caregiver) will be assessed at baseline, 6 months and 9 months
Healthcare utilization (HCU) in survivors and caregivers is the receipt of recommended care assessed by self-report and chart review. HCU will be evaluated based on the number of completed referrals dived by the number of recommended medical or supportive care referrals. We will use count-based regression to model the logarithm of the expected number of completed referrals as a function of treatment group with an offset equal to the logarithm of the total number of patient referrals, and baseline covariate adjustment. Based on the fitted model, we will construct point and interval estimates of the rate of HCU for SNAP and UC (Usual Care) dyads. The significance of the intervention on HCU will be based on the statistical significance of the treatment effect parameter. Primary analyses will use chart review data and additional exploratory analyses will use self-reported data.
Dyads (Survivor & Caregiver) will be assessed at baseline, 6 months and 9 months
Change in from baseline Unmet Needs at 6 months in head and neck cancer Caregivers
Time Frame: Caregivers will be assessed at baseline, 6 weeks, 6 months, 9 months
Unmet needs will be assessed by the Cancer Survivor Partner Unmet Needs (CaSPUN) instrument. Respondents rate 30 items concerning whether they currently needed help with comprehensive care, information, quality of life, existential survivorship and relationship issues (yes or no). Total number of unmet needs will be calculated. Cronbach's alphas in previous research range from 0.93-0.94.
Caregivers will be assessed at baseline, 6 weeks, 6 months, 9 months
Change in from baseline Unmet Needs at 6 months in head and neck cancer Survivors
Time Frame: Survivors will be assessed at baseline, 6 months, 9 months
Unmet needs will be assessed by the Cancer Survivor Unmet Needs (CaSUN) instrument. Respondents rate 30 items concerning whether they currently needed help with comprehensive care, information, quality of life, existential survivorship and relationship issues (yes or no). Total number of unmet needs will be calculated. Cronbach's alphas in previous research range from 0.93-0.94.
Survivors will be assessed at baseline, 6 months, 9 months
Change in from baseline Self-efficacy at 6 months in head and neck cancer Caregivers
Time Frame: Caregivers will be assessed at baseline, 6 weeks, 6 months, 9 months
Caregiver self-efficacy will be assessed with the 21-item Caregiver Inventory measure. Participants will rate the extent to which they feel confident in their abilities as a caregiver to manage medical information, care for their loved one with cancer, manage emotions and care for oneself on a 9 point response scale from not at all confident to totally confident. Higher scores reflect higher self-efficacy (Cronbach's alpha in previous research = 0.91).
Caregivers will be assessed at baseline, 6 weeks, 6 months, 9 months
Change in from baseline Self-efficacy at 6 months in head and neck cancer Survivors
Time Frame: Survivors will be assessed at baseline, 6 months, 9 months
Survivor self-efficacy will be assessed with the 12-item Communication and Attitudinal Self-Efficacy Scale (CASE) instrument. Participants will rate the extent to which they feel confident in understanding and participating in their care, maintaining a positive attitude, and seeking and obtaining information on a 4 point response scale from Strongly Disagree (1) to Strongly Agree (4). Higher scores reflect higher self-efficacy.
Survivors will be assessed at baseline, 6 months, 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine R Sterba, PhD, MPH, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00114288
  • R01CA259186-01 (U.S. NIH Grant/Contract)
  • R01CA259186-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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