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

NCT05811936 | Recruiting

• 3 other identifiers: 00114288R01CA259186-01R01CA259186-02
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Head and Neck Cancer; Survivorship

Outcome Measures

Primary Outcomes (2)

• Change from baseline in Caregiver Burden at 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

  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 Outcomes (9)

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

  Caregivers will be assessed at baseline, 6 months and 9 months

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

  Caregivers will be assessed at baseline, 6 months and 9 months

• Change from baseline in Depression for Survivors at 9 months post randomization

  Survivors will be assessed at baseline, 6 months and 9 months

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

  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.

  Dyads (Survivor & Caregiver) will be assessed at baseline, 6 months and 9 months

Study Arms (2)

Usual Care

NO 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.

SNAP

EXPERIMENTAL

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

Interventions

Survivorship Needs Assessment Planning (SNAP) tool BEHAVIORAL

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.

Also known as: SNAP

SNAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18
• Stage I-IV non-metastatic HNC (i.e., lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, larynx and cutaneous cancers)
• Currently receiving radiation treatment (with/without surgery and/or concurrent chemotherapy) with curative intent
• Able to nominate caregiver, the primary support person, also interested in participating
• Age \>18
• Provide care for a loved one with stage I-IV HNC
• Agrees to participate after being nominated

You may not qualify if:

• Patients who do not read/understand English
• Patients who are cognitively impaired and cannot complete interviews as judged by the referring health care provider
• 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
• Inability to read or understand English
• Cognitively impaired and cannot complete interviews, as judged by the referring health care provider

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Caregiver Burden

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Katherine R Sterba, PhD, MPH

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine R Sterba, PhD, MPH

CONTACT

8438762419; sterba@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Study personnel (Coordinator, Nurse, Data Collectors) will not be blinded to group as intervention activities differ by group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor • COM PHS Administration CC

Model Details: Patient and Caregiver dyads will be randomized to either the SNAP intervention group or the Usual Care (UC) group after baseline assessment. Dyads will be randomized to study arm (SNAP or UC) using permuted block randomization with block sizes of 2 or 4. Randomization will be stratified by patient gender (male or female) and treatment (radiation only, radiation + surgery OR chemotherapy, radiation + surgery + chemotherapy).

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 13, 2023
• Study Start: August 23, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)