Skip to main content
Top
Published in: Archives of Dermatological Research 10/2023

12-09-2023 | Study Protocol

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

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

Published in: Archives of Dermatological Research | Issue 10/2023

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
go back to reference 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):33–50CrossRefPubMed 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):33–50CrossRefPubMed
2.
go back to reference 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):285–292CrossRefPubMed 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):285–292CrossRefPubMed
3.
go back to reference 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):131–140CrossRefPubMed 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):131–140CrossRefPubMed
5.
go back to reference 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):2285–2292CrossRef 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):2285–2292CrossRef
6.
go back to reference Kim YJ, Lee GH, Kwong BY, Martires KJ (2019) Evidence-based, skin-directed treatments for cutaneous chronic graft-versus-host disease. Cureus 11(12):e6462PubMedPubMedCentral Kim YJ, Lee GH, Kwong BY, Martires KJ (2019) Evidence-based, skin-directed treatments for cutaneous chronic graft-versus-host disease. Cureus 11(12):e6462PubMedPubMedCentral
7.
go back to reference Lee SJ, Flowers ME (2008) Recognizing and managing chronic graft-versus-host disease. Hematol Am Soc Hematol Educ Progr 2008:134–141CrossRef Lee SJ, Flowers ME (2008) Recognizing and managing chronic graft-versus-host disease. Hematol Am Soc Hematol Educ Progr 2008:134–141CrossRef
8.
go back to reference 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):287–304CrossRefPubMed 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):287–304CrossRefPubMed
9.
go back to reference 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):1341–1348CrossRef 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):1341–1348CrossRef
10.
go back to reference 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):305–310CrossRef 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):305–310CrossRef
11.
go back to reference 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):4651–4657CrossRefPubMedPubMedCentral 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):4651–4657CrossRefPubMedPubMedCentral
12.
go back to reference 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):76–87CrossRefPubMed 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):76–87CrossRefPubMed
13.
go back to reference 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):299–303CrossRef 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):299–303CrossRef
14.
go back to reference 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):109sCrossRef 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):109sCrossRef
15.
go back to reference 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):376–383CrossRefPubMed 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):376–383CrossRefPubMed
16.
go back to reference 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):154–155CrossRefPubMedPubMedCentral 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):154–155CrossRefPubMedPubMedCentral
17.
go back to reference 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):749–757CrossRefPubMed 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):749–757CrossRefPubMed
18.
go back to reference 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):548–551CrossRefPubMedPubMedCentral 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):548–551CrossRefPubMedPubMedCentral
19.
go back to reference 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 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
20.
go back to reference 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):1541–1551CrossRefPubMed 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):1541–1551CrossRefPubMed
22.
go back to reference 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):722CrossRefPubMedPubMedCentral 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):722CrossRefPubMedPubMedCentral
23.
go back to reference 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):752–758CrossRef 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):752–758CrossRef
24.
go back to reference 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):444–452CrossRef 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):444–452CrossRef
25.
go back to reference Lee SJ, Vogelsang G, Flowers ME (2003) Chronic graft-versus-host disease. Biol Blood Marrow Transplant 9(4):215–233CrossRefPubMed Lee SJ, Vogelsang G, Flowers ME (2003) Chronic graft-versus-host disease. Biol Blood Marrow Transplant 9(4):215–233CrossRefPubMed
26.
go back to reference 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):562–567CrossRef 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):562–567CrossRef
27.
go back to reference Finlay AY, Khan GK (1994) Dermatology Life Quality Index (DLQI)–a simple practical measure for routine clinical use. Clin Exp Dermatol 19(3):210–216CrossRefPubMed Finlay AY, Khan GK (1994) Dermatology Life Quality Index (DLQI)–a simple practical measure for routine clinical use. Clin Exp Dermatol 19(3):210–216CrossRefPubMed
28.
go back to reference 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 3:36CrossRefPubMedPubMedCentral 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 3:36CrossRefPubMedPubMedCentral
29.
go back to reference 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):473–483CrossRefPubMed 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):473–483CrossRefPubMed
30.
go back to reference 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):2148–2158CrossRefPubMedPubMedCentral 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):2148–2158CrossRefPubMedPubMedCentral
31.
go back to reference 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):116CrossRefPubMedPubMedCentral 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):116CrossRefPubMedPubMedCentral
32.
go back to reference Ezhumalai S, Muralidhar D, Dhanasekarapandian R, Nikketha BS (2018) Group interventions. Indian J Psychiatry 60(Suppl 4):S514–S521PubMedPubMedCentral Ezhumalai S, Muralidhar D, Dhanasekarapandian R, Nikketha BS (2018) Group interventions. Indian J Psychiatry 60(Suppl 4):S514–S521PubMedPubMedCentral
33.
go back to reference 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):90–92CrossRefPubMed 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):90–92CrossRefPubMed
Metadata
Title
Protocol for a feasibility trial (EXPRESS-C-GVHD) for an expressive helping intervention within a support group for cutaneous graft-versus-host-disease
Authors
Trisha Kaundinya
Yae Kye
Salma E. El-Behaedi
Jennifer N. Choi
Publication date
12-09-2023
Publisher
Springer Berlin Heidelberg
Published in
Archives of Dermatological Research / Issue 10/2023
Print ISSN: 0340-3696
Electronic ISSN: 1432-069X
DOI
https://doi.org/10.1007/s00403-023-02718-y

Other articles of this Issue 10/2023

Archives of Dermatological Research 10/2023 Go to the issue