Expressive Helping for Stem Cell Transplant Patients

NCT03800758 | Completed Phase 3

• 3 other identifiers: PRO2018-0953R01CA2239632018-1306
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Stem Cell Transplantation; Hematologic Malignancy

Outcome Measures

Primary Outcomes (2)

• Symptom severity: Changes in symptom burden

  MD Anderson Symptom Inventory-Bone Marrow Transplant (MDASI-BMT), which measures both the severity of and interference caused by 13 symptoms, plus 5 transplant-specific symptoms. Symptom severity is rated on a 0-10 scale (0="not present" to 10="As bad as you can imagine") to indicate the severity of symptoms in the past 24 hours. The mean of items are calculated to yield a symptom severity score in which higher scores indicate higher severity.

  Baseline to 3-months post intervention

• Symptom severity: Changes in symptom burden

  MD Anderson Symptom Inventory-Bone Marrow Transplant (MDASI-BMT), which measures both the severity of and interference caused by 13 symptoms, plus 5 transplant-specific symptoms. Symptom severity is rated on a 0-10 scale (0="not present" to 10="As bad as you can imagine") to indicate the severity of symptoms in the past 24 hours. The mean of items are calculated to yield a symptom severity score in which higher scores indicate higher severity.

  Baseline to 12-months post-intervention

Secondary Outcomes (34)

• Symptom severity: Changes in symptom burden

  Baseline to Day 7 post-transplant

• Symptom severity: Changes in symptom burden

  Baseline to Day 14 post-transplant

• Symptom severity: Changes in symptom burden

  Baseline to 1-week post-intervention

• Symptom severity: Changes in symptom burden

  Baseline to 6-months post-intervention

• Depressive symptoms: Changes in depressive symptoms

  Baseline to Day 7 post-transplant

Study Arms (2)

Expressive Helping writing

EXPERIMENTAL

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.

Behavioral: Expressive Helping

Factual Writing

ACTIVE COMPARATOR

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.

Behavioral: Factual Writing

Interventions

Expressive Helping BEHAVIORAL

Expressive Helping (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 using previously-tested EH instructions, adapted for this population.

Expressive Helping writing

Factual Writing BEHAVIORAL

Factual Writing has been used with cancer patients and in the investigators' prior EH trial. It is completed in 4 brief structured writing sessions during and immediately after transplant, with instructions focused on having participants write about their transplant experience using standard Factual Writing instructions.

Factual Writing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator
• Lombardi Comprehensive Cancer Center: collaborator
• Hackensack Meridian Health: collaborator

Study Sites (3)

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Related Publications (1)

• Whitmore L, Schulte T, Bovbjerg K, Hartstein M, Austin J, Luta G, McFarland L, Rowley SD, Nyirenda T, Lewis-Thames M, Stanton AL, Valdimarsdottir H, Graves K, Rini C. 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. 2021 Oct 20;22(1):722. doi: 10.1186/s13063-021-05676-w.

  PMID: 34670600 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cancer Survivorship Institute, Robert H. Lurie Comprehensive Cancer Center

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 11, 2019
• Study Start: March 6, 2019
• Primary Completion: April 24, 2023
• Study Completion: April 24, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)