Clinical trial NCT03800758: Expressive Helping for Stem Cell Transplant Patients
Official title: A Randomized Controlled Trial Testing Expressive Helping for Stem Cell Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stem Cell Transplantation
Hematologic Malignancy
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Lombardi Comprehensive Cancer Center
name: Hackensack Meridian Health
First posted: 2019-01-11
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptom severity: Changes in symptom burden
timeFrame: Baseline to 3-months post intervention
measure: Symptom severity: Changes in symptom burden
timeFrame: Baseline to 12-months post-intervention
Secondary outcomes:
measure: Symptom severity: Changes in symptom burden
timeFrame: Baseline to Day 7 post-transplant
measure: Symptom severity: Changes in symptom burden
timeFrame: Baseline to Day 14 post-transplant
measure: Symptom severity: Changes in symptom burden
timeFrame: Baseline to 1-week post-intervention
measure: Symptom severity: Changes in symptom burden
timeFrame: Baseline to 6-months post-intervention
measure: Depressive symptoms: Changes in depressive symptoms
timeFrame: Baseline to Day 7 post-transplant
measure: Depressive symptoms: Changes in depressive symptoms
timeFrame: Baseline to Day 14 post-transplant
measure: Depressive symptoms: Changes in depressive symptoms
timeFrame: Baseline to 1-week post-intervention
measure: Depressive symptoms: Changes in depressive symptoms
timeFrame: Baseline to 3-months post-intervention
measure: Depressive symptoms: Changes in depressive symptoms
timeFrame: Baseline to 6-months post-intervention
measure: Depressive symptoms: Changes in depressive symptoms
timeFrame: Baseline to 12-months post-intervention
measure: Generalized Anxiety: Changes in symptoms of generalized anxiety
timeFrame: Baseline to Day 7 post-transplant
measure: Generalized Anxiety: Changes in symptoms of generalized anxiety
timeFrame: Baseline to Day 14 post-transplant
measure: Generalized Anxiety: Changes in symptoms of generalized anxiety
timeFrame: Baseline to 1-week post-intervention
measure: Generalized Anxiety: Changes in symptoms of generalized anxiety
timeFrame: Baseline to 3-months post-intervention
measure: Generalized Anxiety: Changes in symptoms of generalized anxiety
timeFrame: Baseline to 6-months post-intervention
measure: Generalized Anxiety: Changes in symptoms of generalized anxiety
timeFrame: Baseline to 12-months post-intervention
measure: Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
timeFrame: Baseline to Day 7 post-transplant
measure: Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
timeFrame: Baseline to Day 14 post-transplant
measure: Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
timeFrame: Baseline to 1-week post-intervention
measure: Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
timeFrame: Baseline to 3-months post-intervention
measure: Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
timeFrame: Baseline to 6-months post-intervention
measure: Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
timeFrame: Baseline to 12-months post-intervention
measure: Quality of life: Changes in quality of life
timeFrame: Baseline to Day 7 post-transplant
measure: Quality of life: Changes in quality of life
timeFrame: Baseline to Day 14 post-transplant
measure: Quality of life: Changes in quality of life
timeFrame: Baseline to 1-week post-intervention
measure: Quality of life: Changes in quality of life
timeFrame: Baseline to 3-months post-intervention
measure: Quality of life: Changes in quality of life
timeFrame: Baseline to 6-months post-intervention
measure: Quality of life: Changes in quality of life
timeFrame: Baseline to 12-months post-intervention
measure: Fatigue: Changes in fatigue
timeFrame: Baseline to Day 7 post-transplant
measure: Fatigue: Changes in fatigue
timeFrame: Baseline to Day 14 post-transplant
measure: Fatigue: Changes in fatigue
timeFrame: Baseline to 1-week post-intervention
measure: Fatigue: Changes in fatigue
timeFrame: Baseline to 3-month post-intervention
measure: Fatigue: Changes in fatigue
timeFrame: Baseline to 6-month post-intervention
measure: Fatigue: Changes in fatigue
timeFrame: Baseline to 12-month post-intervention
Other outcomes:
Locations:
city: Washington
country: United States
facility: Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
state: District of Columbia
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
Study officials:
References:
citation: 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.