Expressive Helping for Stem Cell Transplant Patients

Last updated: May 3, 2023
Sponsor: Northwestern University
Overall Status: Completed

Phase

3

Condition

Bone Marrow Transplant

Blood Cancer

Hematologic Neoplasms

Treatment

Factual Writing

Expressive Helping

Clinical Study ID

NCT03800758
PRO2018-0953
R01CA223963
2018-1306
  • Ages > 18
  • All Genders

Study Summary

The Writing for Insight, Strength, and Ease (WISE) Study is a multisite Randomized Controlled Trial (RCT) testing the efficacy of the Expressive Helping (EH) intervention among adults receiving hematopoietic stem cell transplantation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cancer patients
  • Age ≥ 18
  • English proficient
  • Scheduled for allogeneic or autologous transplant at JTCC, LCCC, or RHLCC.

Exclusion

Exclusion Criteria:

  • Current participation in a behavioral intervention targeting symptoms or quality oflife
  • Cognitive or psychiatric impairment precluding ability to complete informed consent orstudy procedures
  • Literacy limitations precluding completion of a writing study
  • Undergoing a tandem transplant where participant is now completing the first of two ormore planned transplants

Study Design

Total Participants: 405
Treatment Group(s): 2
Primary Treatment: Factual Writing
Phase: 3
Study Start date:
March 06, 2019
Estimated Completion Date:
April 24, 2023

Study Description

Use of stem cell transplant (mostly for hematologic cancers) is expected to increase 5-fold by 2030, when the number of survivors will reach 500,000. This highly toxic treatment causes a range of acute physical and psychological symptoms, which then persist for years for up to 45% of patients. To address gaps in existing symptom-focused behavioral interventions that can be added to standard patient care, the investigators developed Expressive Helping (EH), a low-cost, low-burden intervention that targets a range of physical and psychological symptoms in a broad group of transplant recipients. EH is completed in 4 brief structured writing sessions during and immediately after transplant, with instructions focused on having participants write about their transplant experience. Based on promising preliminary data, the investigators propose to determine whether EH can be used during and immediately after transplant to reduce common acute physical and psychological symptoms and prevent development of persistent physical and psychological symptoms. Assessments of physical symptoms and psychological symptoms will occur at baseline (prior to randomization), "nadir" (Day 7 post-transplant), "engraftment" (Day 14 post-transplant), 1 week post-intervention, 3-months post-intervention (primary endpoint, early post-transplant), 6-months post-intervention, and 12-months post-intervention (primary endpoint, later post-transplant). The investigators will also assess a select set of potential mediators and moderators of intervention effects. Participants will be adult cancer patients scheduled for allogeneic or autologous stem cell transplant at the study sites. After screening and consent, eligible patients will be enrolled in a parallel-group, 1:1 randomized controlled trial. Randomization will be stratified by study site (JTCC, Lombardi Comprehensive Cancer Center, LCCC, or Robert H. Lurie Comprehensive Cancer Center, RHLCCC); sex (linked with patient outcomes), age (18-59, ≥ 60), and transplant type (autologous, allogeneic). Staff performing assessments will be blind to study assignment. Participants cannot be blinded, but hypotheses will not be revealed to them until trial completion. They will be asked not to reveal their assignment to staff.

Connect with a study center

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

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