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Designing Psychosocial Intervention Pilot Studies: A Tutorial for Palliative Care Investigators.

Publication ,  Journal Article
Winger, JG; Kelleher, SA; Fisher, HM; Somers, TJ; Samsa, GP
Published in: J Pain Symptom Manage
June 2022

This is a tutorial on designing a persuasive pilot study of a psychosocial intervention (e.g., behavioral symptom management) in the palliative care setting. This tutorial is most relevant for early stages of intervention research that aims to progress toward a randomized controlled trial with a high degree of internal validity. Broadly, a pilot study aims to address multiple elements of feasibility and acceptability so that investigators are well positioned for the next study in their program of research. To assist investigators in writing compelling grant applications we designed this tutorial as an annotated checklist of goals that a pilot study within the palliative care domain should seek to accomplish. These goals include the following: 1) begin with the end in mind, 2) use a formal conceptual model, 3) use measures with strong psychometric properties, 4) justify the timing of study sessions and assessments, 5) test recruitment methods, 6) estimate retention, 7) assess interventionist fidelity, 8) assess acceptability of the intervention, 9) assess feasibility, and 10) identify barriers to the next study. We elaborate on these goals by describing an ongoing pilot study testing the feasibility and acceptability of a psychosocial pain management intervention for patients with advanced cancer. Pilot studies are crucial for building a successful program of research, but they are also limited in terms of their sample size and overall objectives. A persuasive pilot study is one that is limited yet useful rather than limited and trivial.

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Published In

J Pain Symptom Manage

DOI

EISSN

1873-6513

Publication Date

June 2022

Volume

63

Issue

6

Start / End Page

e749 / e755

Location

United States

Related Subject Headings

  • Randomized Controlled Trials as Topic
  • Psychosocial Intervention
  • Pilot Projects
  • Palliative Care
  • Humans
  • Hospice and Palliative Care Nursing
  • Feasibility Studies
  • Anesthesiology
  • 42 Health sciences
  • 32 Biomedical and clinical sciences
 

Citation

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Winger, J. G., Kelleher, S. A., Fisher, H. M., Somers, T. J., & Samsa, G. P. (2022). Designing Psychosocial Intervention Pilot Studies: A Tutorial for Palliative Care Investigators. J Pain Symptom Manage, 63(6), e749–e755. https://doi.org/10.1016/j.jpainsymman.2022.02.338
Winger, Joseph G., Sarah A. Kelleher, Hannah M. Fisher, Tamara J. Somers, and Gregory P. Samsa. “Designing Psychosocial Intervention Pilot Studies: A Tutorial for Palliative Care Investigators.J Pain Symptom Manage 63, no. 6 (June 2022): e749–55. https://doi.org/10.1016/j.jpainsymman.2022.02.338.
Winger JG, Kelleher SA, Fisher HM, Somers TJ, Samsa GP. Designing Psychosocial Intervention Pilot Studies: A Tutorial for Palliative Care Investigators. J Pain Symptom Manage. 2022 Jun;63(6):e749–55.
Winger, Joseph G., et al. “Designing Psychosocial Intervention Pilot Studies: A Tutorial for Palliative Care Investigators.J Pain Symptom Manage, vol. 63, no. 6, June 2022, pp. e749–55. Pubmed, doi:10.1016/j.jpainsymman.2022.02.338.
Winger JG, Kelleher SA, Fisher HM, Somers TJ, Samsa GP. Designing Psychosocial Intervention Pilot Studies: A Tutorial for Palliative Care Investigators. J Pain Symptom Manage. 2022 Jun;63(6):e749–e755.
Journal cover image

Published In

J Pain Symptom Manage

DOI

EISSN

1873-6513

Publication Date

June 2022

Volume

63

Issue

6

Start / End Page

e749 / e755

Location

United States

Related Subject Headings

  • Randomized Controlled Trials as Topic
  • Psychosocial Intervention
  • Pilot Projects
  • Palliative Care
  • Humans
  • Hospice and Palliative Care Nursing
  • Feasibility Studies
  • Anesthesiology
  • 42 Health sciences
  • 32 Biomedical and clinical sciences