Expressive Helping for Stem Cell Transplant Patients

Northwestern University

Status and phase: Completed; Phase 3

Conditions: Hematologic Malignancy; Stem Cell Transplantation

Treatments: Behavioral: Factual Writing; Behavioral: Expressive Helping

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03800758

PRO2018-0953

2018-1306 (Other Identifier)

R01CA223963 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 405 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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405 participants in 2 patient groups

Expressive Helping writing

Experimental group

Description:

Writing sessions 1-3: Participants complete one 20-minute expressive writing session at three time points: 1) after hospitalization but prior to transplant infusion, (2) approximately 3 days after hospital discharge, and (3) approximately 2 weeks after completion of writing session 2. Writing session 4: One 20-40 minute peer support writing session about 1 week after completion of writing session 3.

Treatment:

Behavioral: Expressive Helping

Factual Writing

Active Comparator group

Description:

Writing sessions 1-3: Participants complete one 20-minute factual session at three time points: 1) after hospitalization but prior to transplant infusion, (2) approximately 3 days after hospital discharge, and (3) approximately 2 weeks after completion of writing session 2. Writing session 4: One 20-40 minute factual writing session about 1 week after completion of writing session 3.

Treatment:

Behavioral: Factual Writing