Skip to main content

Advertisement

SpringerLink
Log in

Protocol for a feasibility trial (EXPRESS-C-GVHD) for an expressive helping intervention within a support group for cutaneous graft-versus-host-disease

  • Study Protocol
  • Published:
Archives of Dermatological Research Aims and scope Submit manuscript

Abstract

Background

Cutaneous graft-versus-host disease (cuGVHD) is a complication of allogeneic hematopoietic stem cell transplantation that presents with varying severity and can significantly affect one’s quality of life (QOL). No trials have yet tested nonpharmacologic interventions to improve the QOL of patients with cuGVHD. The primary objective of the Expressive Helping in Support Groups for Cutaneous GVHD (EXPRESS-C-GVHD) Trial is to evaluate the effect of a support group that employs expressive writing on cutaneous and systemic GVHD symptoms, general distress, and QOL immediately after the intervention. Secondary objectives include evaluating the impact of the intervention on QOL at 1 month post intervention, as well as willingness to participate, compliance, feasibility, and satisfaction.

Methods

The EXPRESS-C-GVHD Trial will include patients with chronic cuGVHD who are at least 18 years old and able to use a writing utensil, have access to Zoom, an online video conference platform, and attend all four live support group sessions. Subjects will be recruited from the Department of Dermatology, Northwestern University, Chicago, IL and will participate in a 4 week program via Zoom. Program activities will be 1 h long and consist of 40 min of participant-led verbal reflection and discussion in a group setting in response to prompts, and 20 min of expressive writing. Participants will fill out a baseline willingness survey, follow-up surveys after every session, and post-intervention surveys at 2 weeks and 1 month after intervention.

Discussion

The EXPRESS-C-GVHD Trial is a pilot trial and will assess whether a Zoom-based expressive writing intervention within the framework of a support group is feasible and can improve QOL outcomes among individuals with cuGVHD.

Trial Registration

The trial is registered under number NCT05694832.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

Data availability

Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.

Abbreviations

GVHD:

Graft-versus-host-disease

cuGVHD:

Cutaneous graft-versus-host disease

cGVHD:

Chronic graft-versus-host disease

QOL:

Quality of life

EXPRESS-C-GVHD:

Expressive Helping in Support Groups for Cutaneous GVHD

HSCT:

Hematopoietic stem cell transplant

PROM:

Patient reported outcome measure

DLQI:

Dermatology life quality index

SF36:

Short Form-36

References

  1. Strong Rodrigues K, Oliveira-Ribeiro C, De Gomes SAF, Knobler R (2018) Cutaneous graft-versus-host disease: diagnosis and treatment. Am J Clin Dermatol 19(1):33–50

    Article  PubMed  Google Scholar 

  2. Sung AD, Chao NJ (2013) Acute graft-versus-host disease: are we close to bringing the bench to the bedside? Best Pract Res Clin Haematol 26(3):285–292

    Article  PubMed  Google Scholar 

  3. Kavand S, Lehman JS, Hashmi S, Gibson LE, El-Azhary RA (2017) Cutaneous manifestations of graft-versus-host disease: role of the dermatologist. Int J Dermatol 56(2):131–140

    Article  PubMed  Google Scholar 

  4. Wu JH, Cohen BA (2019) The stigma of skin disease. Curr Opin Pediatr 31(4):509–514

    Article  PubMed  Google Scholar 

  5. El-Jawahri A, Pidala J, Khera N, Wood WA, Arora M, Carpenter PA et al (2018) Impact of psychological distress on quality of life, functional status, and survival in patients with chronic graft-versus-host disease. Biol Blood Marrow Transpl 24(11):2285–2292

    Article  Google Scholar 

  6. Kim YJ, Lee GH, Kwong BY, Martires KJ (2019) Evidence-based, skin-directed treatments for cutaneous chronic graft-versus-host disease. Cureus 11(12):e6462

    PubMed  PubMed Central  Google Scholar 

  7. Lee SJ, Flowers ME (2008) Recognizing and managing chronic graft-versus-host disease. Hematol Am Soc Hematol Educ Progr 2008:134–141

    Article  Google Scholar 

  8. Häusermann P, Walter RB, Halter J, Biedermann BC, Tichelli A, Itin P et al (2008) Cutaneous graft-versus-host disease: a guide for the dermatologist. Dermatology 216(4):287–304

    Article  PubMed  Google Scholar 

  9. El-Jawahri A, Pidala J, Inamoto Y, Chai X, Khera N, Wood WA et al (2014) Impact of age on quality of life, functional status, and survival in patients with chronic graft-versus-host disease. Biol Blood Marrow Transpl 20(9):1341–1348

    Article  Google Scholar 

  10. Lee SJ, Kim HT, Ho VT, Cutler C, Alyea EP, Soiffer RJ et al (2006) Quality of life associated with acute and chronic graft-versus-host disease. Bone Marrow Transpl 38(4):305–310

    Article  CAS  Google Scholar 

  11. Pidala J, Kurland B, Chai X, Majhail N, Weisdorf DJ, Pavletic S et al (2011) Patient-reported quality of life is associated with severity of chronic graft-versus-host disease as measured by NIH criteria: report on baseline data from the chronic GVHD consortium. Blood 117(17):4651–4657

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  12. Cho A, Paulitschke V, Just U, Knobler R (2020) Cutaneous manifestations of acute and chronic graft-versus-host disease. G Ital Dermatol Venereol 155(1):76–87

    Article  PubMed  Google Scholar 

  13. Jim HS, Quinn GP, Gwede CK, Cases MG, Barata A, Cessna J et al (2014) Patient education in allogeneic hematopoietic cell transplant: what patients wish they had known about quality of life. Bone Marrow Transpl 49(2):299–303

    Article  CAS  Google Scholar 

  14. Okwor V, Nwankwo K, Obidiebube P, Lasebikan N, Okwor C, Okoye I et al (2018) Impact of support group intervention on quality of life of patients with advanced breast cancer. J Global Oncol 4(2):109s

    Article  Google Scholar 

  15. Subramaniam V, Stewart MW, Smith JF (1999) The development and impact of a chronic pain support group: a qualitative and quantitative study. J Pain Symptom Manage 17(5):376–383

    Article  CAS  PubMed  Google Scholar 

  16. Stout M (2020) The role of virtual support groups for patients with hidradenitis suppurativa during the COVID-19 pandemic. Int J Womens Dermatol 6(3):154–155

    Article  PubMed  PubMed Central  Google Scholar 

  17. Henry EA, Schlegel RJ, Talley AE, Molix LA, Bettencourt BA (2010) The feasibility and effectiveness of expressive writing for rural and urban breast cancer survivors. Oncol Nurs Forum 37(6):749–757

    Article  PubMed  Google Scholar 

  18. Lu Q, Zheng D, Young L, Kagawa-Singer M, Loh A (2012) A pilot study of expressive writing intervention among Chinese-speaking breast cancer survivors. Health Psychol 31(5):548–551

    Article  PubMed  PubMed Central  Google Scholar 

  19. Pennebaker JW, Chung CK (2011) Expressive Writing: Connections to Physical and Mental Health. In: Friedman HS (ed) The Oxford Handbook of Health Psychology. Oxford University Press, Oxford, p 417

    Google Scholar 

  20. Rini C, Austin J, Wu LM, Winkel G, Valdimarsdottir H, Stanton AL et al (2014) Harnessing benefits of helping others: a randomized controlled trial testing expressive helping to address survivorship problems after hematopoietic stem cell transplant. Health Psychol 33(12):1541–1551

    Article  PubMed  Google Scholar 

  21. Thabane L, Lancaster G (2019) A guide to the reporting of protocols of pilot and feasibility trials. Pilot and Feasibility Studies 5(1):37

    Article  PubMed  PubMed Central  Google Scholar 

  22. Whitmore L, Schulte T, Bovbjerg K, Hartstein M, Austin J, Luta G et al (2021) Efficacy of expressive helping in adult hematologic cancer patients undergoing stem cell transplant: protocol for the Writing for Insight, Strength, and Ease (WISE) study’s two-arm randomized controlled trial. Trials 22(1):722

    Article  PubMed  PubMed Central  Google Scholar 

  23. Merkel EC, Mitchell SA, Lee SJ (2016) Content validity of the Lee chronic graft-versus-host disease symptom scale as assessed by cognitive interviews. Biol Blood Marrow Transpl 22(4):752–758

    Article  Google Scholar 

  24. Lee S, Cook EF, Soiffer R, Antin JH (2002) Development and validation of a scale to measure symptoms of chronic graft-versus-host disease. Biol Blood Marrow Transpl 8(8):444–452

    Article  Google Scholar 

  25. Lee SJ, Vogelsang G, Flowers ME (2003) Chronic graft-versus-host disease. Biol Blood Marrow Transplant 9(4):215–233

    Article  CAS  PubMed  Google Scholar 

  26. Teh C, Onstad L, Lee SJ (2020) Reliability and validity of the modified 7-day Lee chronic graft-versus-host disease symptom scale. Biol Blood Marrow Transpl 26(3):562–567

    Article  Google Scholar 

  27. Finlay AY, Khan GK (1994) Dermatology Life Quality Index (DLQI)–a simple practical measure for routine clinical use. Clin Exp Dermatol 19(3):210–216

    Article  CAS  PubMed  Google Scholar 

  28. Shikiar R, Harding G, Leahy M, Lennox RD (2005) Minimal important difference (MID) of the Dermatology Life Quality Index (DLQI): results from patients with chronic idiopathic urticaria. Health Qual Life Outcomes 3:36

    Article  PubMed  PubMed Central  Google Scholar 

  29. Ware JE Jr, Sherbourne CD (1992) The MOS 36-item short-form health survey (SF-36). I conceptual framework and item selection. Med Care 30(6):473–483

    Article  PubMed  Google Scholar 

  30. Ogura K, Yakoub MA, Christ AB, Fujiwara T, Nikolic Z, Boland PJ et al (2020) What are the minimum clinically important differences in SF-36 scores in patients with orthopaedic oncologic conditions? Clin Orthop Relat Res 478(9):2148–2158

    Article  PubMed  PubMed Central  Google Scholar 

  31. Biggs K, Hind D, Gossage-Worrall R, Sprange K, White D, Wright J et al (2020) Challenges in the design, planning and implementation of trials evaluating group interventions. Trials 21(1):116

    Article  PubMed  PubMed Central  Google Scholar 

  32. Ezhumalai S, Muralidhar D, Dhanasekarapandian R, Nikketha BS (2018) Group interventions. Indian J Psychiatry 60(Suppl 4):S514–S521

    PubMed  PubMed Central  Google Scholar 

  33. Freites-Martinez A, Santana N, Arias-Santiago S, Viera A (2021) Using the common terminology criteria for adverse events (CTCAE-Version 5.0) to evaluate the severity of adverse events of anticancer therapies. Actas Dermosifiliogr (Engl Ed) 112(1):90–92

    Article  CAS  PubMed  Google Scholar 

Download references

Funding

None. No funding or sponsorship was received for any aspect of this article, including design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.

Author information

Authors and Affiliations

  1. Northwestern University Feinberg School of Medicine, Chicago, IL, 60611, USA

    Trisha Kaundinya

  2. Department of Dermatology, Northwestern University Feinberg School of Medicine, 676 N. St. Clair Suite 1600, Chicago, IL, 60611, USA

    Trisha Kaundinya, Yae Kye, Salma E. El-Behaedi & Jennifer N. Choi

  3. Paul L Foster School of Medicine, Texas Tech University Health Sciences Center, El Paso, TX, USA

    Yae Kye

  4. University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA

    Salma E. El-Behaedi

Authors
  1. Trisha Kaundinya
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Yae Kye
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Salma E. El-Behaedi
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Jennifer N. Choi
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

TK and JC devised project. TK, YK, and SE drafted the manuscript. TK, YK, SE, and JC revised the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Jennifer N. Choi.

Ethics declarations

Conflict of interest

All authors declare that they have no competing interests or conflicts of interest.

Ethical approval

The EXPRESS-C-GVHD Trial has been approved by the Research Ethics Committee (STU00216774). Any modifications to the protocol which may have an impact on the conduct of the study will undergo a formal amendment to the protocol, will be submitted to the Research Ethics Committee for approval and documented in the trial's registration.

Consent to participate

All participants will provide electronic consent prior to taking part in the study.

Consent for publication

Not applicable.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (PDF 172 kb)

Supplementary file2 (PDF 259 kb)

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Kaundinya, T., Kye, Y., El-Behaedi, S.E. et al. Protocol for a feasibility trial (EXPRESS-C-GVHD) for an expressive helping intervention within a support group for cutaneous graft-versus-host-disease. Arch Dermatol Res 315, 2905–2912 (2023). https://doi.org/10.1007/s00403-023-02718-y

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00403-023-02718-y

Keywords

Search

Navigation