Efficacy of expressive helping in adult hematologic cancer patients undergoing stem cell transplant: protocol for the Writing for Insight, Strength, and Ease (WISE) study\u2019s two-arm randomized controlled trial

Lauren Whitmore,Christine Rini,Katrin Bovbjerg,Marquita Lewis-Thames,Annette L Stanton,George Luta,Taylor Schulte,Scott D Rowley,Jane Austin,Lily Mcfarland,Heiddis Valdimarsdottir,Madison Hartstein,Themba Nyirenda,Kristi Graves

doi:10.1186/s13063-021-05676-w

Abstract

BackgroundDuring, shortly after, and sometimes for years after hematopoietic stem cell transplant, a large proportion of hematological cancer patients undergoing transplant report significant physical and psychological symptoms and reduced health-related quality of life. To address these survivorship problems, we developed a low-burden, brief psychological intervention called expressive helping that includes two theory- and evidence-based components designed to work together synergistically: emotionally expressive writing and peer support writing. Building on evidence from a prior randomized control trial showing reductions in physical symptoms and distress in long-term transplant survivors with persistent survivorship problems, the Writing for Insight, Strength, and Ease (WISE) trial will evaluate the efficacy of expressive helping when used during transplant and in the early post-transplant period, when symptoms peak, and when intervention could prevent development of persistent symptoms.MethodsWISE is a multi-site, two-arm randomized controlled efficacy trial. Adult hematological cancer patients scheduled for a hematopoietic stem cell transplant will complete baseline measures and then, after hospitalization but prior to transplant, they will be randomized to complete either expressive helping or a time and attention “neutral writing” task. Both expressive helping and neutral writing involve four brief writing sessions, beginning immediately after randomization and ending approximately 4 weeks after hospital discharge. Measures of symptom burden (primary outcome), distress, health-related quality of life, and fatigue (secondary outcomes) will be administered in seven assessments coinciding with medically relevant time points from baseline and to a year post-intervention.DiscussionThe steady and continuing increase in use of stem cell transplantation has created growing need for efficacious, accessible interventions to reduce the short- and long-term negative physical and psychosocial effects of this challenging but potentially life-saving treatment. Expressive helping is a psychological intervention that was designed to fill this gap. It has been shown to be efficacious in long-term transplant survivors but could have even greater impact if it is capable of reducing symptoms during and soon after transplant. The WISE study will evaluate these benefits in a rigorous randomized controlled trial.Trial registrationClinicaltrial.govNCT03800758. Registered January 11, 2019

Highlights

Background and rationale {6a} Hematopoietic stem cell transplant is used to treat hematological malignancies such as acute leukemia, lymphoma, and multiple myeloma, in addition to other malignant and non-malignant conditions
Adult hematological cancer patients scheduled for a hematopoietic stem cell transplant will complete baseline measures and after hospitalization but prior to transplant, they will be randomized to complete either expressive helping or a time and attention “neutral writing” task
Often capable of saving or substantially extending patients’ lives, transplant is associated with significant symptom burdens, namely physical and psychosocial burden due to medical factors and psychosocial stressors [2,3,4,5,6]

Summary

Introduction

Background and rationale {6a} Hematopoietic stem cell transplant is used to treat hematological malignancies such as acute leukemia, lymphoma, and multiple myeloma, in addition to other malignant and non-malignant conditions. As an adjunct to medical treatments and psychosocial resources targeting these issues, transplant recipients could benefit from efficacious, accessible psychological interventions capable of reducing the short- and long-term negative physical and psychosocial effects of this challenging but potentially life-saving treatment To meet this need, we developed a psychological intervention called expressive helping [19]. Shortly after, and sometimes for years after hematopoietic stem cell transplant, a large proportion of hematological cancer patients undergoing transplant report significant physical and psychological symptoms and reduced health-related quality of life To address these survivorship problems, we developed a lowburden, brief psychological intervention called expressive helping that includes two theory- and evidence-based components designed to work together synergistically: emotionally expressive writing and peer support writing. Building on evidence from a prior randomized control trial showing reductions in physical symptoms and distress in long-term transplant survivors with persistent survivorship problems, the Writing for Insight, Strength, and Ease (WISE) trial will evaluate the efficacy of expressive helping when used during transplant and in the early posttransplant period, when symptoms peak, and when intervention could prevent development of persistent symptoms.

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Conclusion