RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-23
Study Completion:2026-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05811936

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \>18
  2. 2. Stage I-IV non-metastatic HNC (i.e., lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, larynx and cutaneous cancers)
  3. 3. Currently receiving radiation treatment (with/without surgery and/or concurrent chemotherapy) with curative intent
  4. 4. Able to nominate caregiver, the primary support person, also interested in participating
  1. 1. Patients who do not read/understand English
  2. 2. Patients who are cognitively impaired and cannot complete interviews as judged by the referring health care provider
  3. 3. Patients concurrently diagnosed with and/or receiving treatment for a second "significant" primary cancer, except the following:
  4. * Excised and cured non-melanoma skin cancer
  5. * Carcinoma in situ of breast or cervix
  6. * Superficial bladder cancer
  7. * Stage 1 differentiated thyroid cancer that is resected or observed
  8. * pT1a/pT1b prostate cancer comprising \<5% of resected tissue with normal prostate specific antigen (PSA) since resection
  9. * cT1a/cT1b prostate cancer treated with brachytherapy

Contacts and Locations

Study Contact

Katherine R Sterba, PhD, MPH
CONTACT
8438762419
sterba@musc.edu

Principal Investigator

Katherine R Sterba, PhD, MPH
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Katherine R Sterba, PhD, MPH, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2023-08-23
Study Completion Date2026-05-31

Study Record Updates

Study Start Date2023-08-23
Study Completion Date2026-05-31

Terms related to this study

Keywords Provided by Researchers

  • Head and Neck Cancer
  • Survivorship

Additional Relevant MeSH Terms

  • Head and Neck Cancer
  • Survivorship
  • Caregiver Burden
  • Head and Neck Neoplasms