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The Head and Neck Survivorship Tool (HN-STAR) Trial (WF-1805CD): A protocol for a cluster-randomized, hybrid effectiveness-implementation, pragmatic trial to improve the follow-up care of head and neck cancer survivors.

Publication ,  Journal Article
Salz, T; Ostroff, JS; Nightingale, CL; Atkinson, TM; Davidson, EC; Jinna, SR; Kriplani, A; Lesser, GJ; Lynch, KA; Mayer, DK; Oeffinger, KC ...
Published in: Contemp Clin Trials
August 2021

Survivors of head and neck cancer (HNC) can have multiple health concerns. To facilitate their care, we developed and pilot-tested a clinical informatics intervention, HN-STAR. HN-STAR elicits concerns online from HNC survivors prior to a routine oncology clinic visit. HN-STAR then presents tailored evidence-based clinical recommendations as a clinical decision support tool to be used during the visit where the oncology clinician and survivor select symptom management strategies and other actions. This generates a survivorship care plan (SCP). Online elicitation of health concerns occurs 3, 6, and 9 months after the clinic visit, generating an updated SCP each time. HN-STAR encompasses important methods of improving survivorship care (e.g., needs assessment, tailored interventions, dissemination of guidelines) and will be evaluated in a pragmatic trial to maximize external validity. This hybrid type 1 implementation-effectiveness trial tests HN-STAR effectiveness while studying barriers and facilitators to implementation in community oncology practices within the National Cancer Institute Community Oncology Research Program. Effectiveness will be measured as differences in key survivorship outcomes between HNC participants who do and do not use HN-STAR over one year after the clinic visit. The primary endpoint is HNC-specific quality of life; other outcomes include patient-centered measures and receipt of guideline-concordant care. Implementation outcomes will be assessed of survivors, providers, and clinic stakeholders. The hybrid design will provide insight into a dose-response relationship between the extent of implementation fidelity and effectiveness outcomes, as well as how to incorporate HN-STAR into standard practice outside the research setting.

Duke Scholars

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

August 2021

Volume

107

Start / End Page

106448

Location

United States

Related Subject Headings

  • Survivorship
  • Survivors
  • Randomized Controlled Trials as Topic
  • Quality of Life
  • Public Health
  • Pragmatic Clinical Trials as Topic
  • Humans
  • Head and Neck Neoplasms
  • General Clinical Medicine
  • Aftercare
 

Citation

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Salz, T., Ostroff, J. S., Nightingale, C. L., Atkinson, T. M., Davidson, E. C., Jinna, S. R., … Weaver, K. E. (2021). The Head and Neck Survivorship Tool (HN-STAR) Trial (WF-1805CD): A protocol for a cluster-randomized, hybrid effectiveness-implementation, pragmatic trial to improve the follow-up care of head and neck cancer survivors. Contemp Clin Trials, 107, 106448. https://doi.org/10.1016/j.cct.2021.106448
Salz, Talya, Jamie S. Ostroff, Chandylen L. Nightingale, Thomas M. Atkinson, Eleanor C. Davidson, Sankeerth R. Jinna, Anuja Kriplani, et al. “The Head and Neck Survivorship Tool (HN-STAR) Trial (WF-1805CD): A protocol for a cluster-randomized, hybrid effectiveness-implementation, pragmatic trial to improve the follow-up care of head and neck cancer survivors.Contemp Clin Trials 107 (August 2021): 106448. https://doi.org/10.1016/j.cct.2021.106448.
Salz T, Ostroff JS, Nightingale CL, Atkinson TM, Davidson EC, Jinna SR, Kriplani A, Lesser GJ, Lynch KA, Mayer DK, Oeffinger KC, Patil S, Salner AL, Weaver KE. The Head and Neck Survivorship Tool (HN-STAR) Trial (WF-1805CD): A protocol for a cluster-randomized, hybrid effectiveness-implementation, pragmatic trial to improve the follow-up care of head and neck cancer survivors. Contemp Clin Trials. 2021 Aug;107:106448.
Journal cover image

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

August 2021

Volume

107

Start / End Page

106448

Location

United States

Related Subject Headings

  • Survivorship
  • Survivors
  • Randomized Controlled Trials as Topic
  • Quality of Life
  • Public Health
  • Pragmatic Clinical Trials as Topic
  • Humans
  • Head and Neck Neoplasms
  • General Clinical Medicine
  • Aftercare