Expressive Helping for Stem Cell Transplant Patients

Hematologic Malignancy Clinical Trial

Official title:

A Randomized Controlled Trial Testing Expressive Helping for Stem Cell Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03800758
• Other study ID #: PRO2018-0953
• Secondary ID: R01CA2239632018-
• Status: Completed
• Phase: Phase 3
• Start date: March 6, 2019
• Est. completion date: April 24, 2023

Study information

• Verified date: May 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: April 24, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Stem Cell Transplantation

Intervention

Behavioral:
• Expressive Helping
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.
• Factual Writing
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.

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Northwestern University	Hackensack Meridian Health, Lombardi Comprehensive Cancer Center, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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 Day 7 post-transplant
Secondary	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 Day 14 post-transplant
Secondary	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 1-week post-intervention
Secondary	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 6-months post-intervention
Secondary	Depressive symptoms: Changes in depressive symptoms	Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = "Rarely or None of the Time," 1 = "Some or Little of the Time," 2 = "Moderately or Much of the time," 3 = "Most or Almost All the Time"). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.	Baseline to Day 7 post-transplant
Secondary	Depressive symptoms: Changes in depressive symptoms	Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = "Rarely or None of the Time," 1 = "Some or Little of the Time," 2 = "Moderately or Much of the time," 3 = "Most or Almost All the Time"). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.	Baseline to Day 14 post-transplant
Secondary	Depressive symptoms: Changes in depressive symptoms	Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = "Rarely or None of the Time," 1 = "Some or Little of the Time," 2 = "Moderately or Much of the time," 3 = "Most or Almost All the Time"). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.	Baseline to 1-week post-intervention
Secondary	Depressive symptoms: Changes in depressive symptoms	Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = "Rarely or None of the Time," 1 = "Some or Little of the Time," 2 = "Moderately or Much of the time," 3 = "Most or Almost All the Time"). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.	Baseline to 3-months post-intervention
Secondary	Depressive symptoms: Changes in depressive symptoms	Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = "Rarely or None of the Time," 1 = "Some or Little of the Time," 2 = "Moderately or Much of the time," 3 = "Most or Almost All the Time"). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.	Baseline to 6-months post-intervention
Secondary	Depressive symptoms: Changes in depressive symptoms	Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = "Rarely or None of the Time," 1 = "Some or Little of the Time," 2 = "Moderately or Much of the time," 3 = "Most or Almost All the Time"). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.	Baseline to 12-months post-intervention
Secondary	Generalized Anxiety: Changes in symptoms of generalized anxiety	Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0="Not at all," 1="Several days," 2="More than half the days," 3="Nearly every day"). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.	Baseline to Day 7 post-transplant
Secondary	Generalized Anxiety: Changes in symptoms of generalized anxiety	Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0="Not at all," 1="Several days," 2="More than half the days," 3="Nearly every day"). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.	Baseline to Day 14 post-transplant
Secondary	Generalized Anxiety: Changes in symptoms of generalized anxiety	Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0="Not at all," 1="Several days," 2="More than half the days," 3="Nearly every day"). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.	Baseline to 1-week post-intervention
Secondary	Generalized Anxiety: Changes in symptoms of generalized anxiety	Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0="Not at all," 1="Several days," 2="More than half the days," 3="Nearly every day"). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.	Baseline to 3-months post-intervention
Secondary	Generalized Anxiety: Changes in symptoms of generalized anxiety	Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0="Not at all," 1="Several days," 2="More than half the days," 3="Nearly every day"). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.	Baseline to 6-months post-intervention
Secondary	Generalized Anxiety: Changes in symptoms of generalized anxiety	Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0="Not at all," 1="Several days," 2="More than half the days," 3="Nearly every day"). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.	Baseline to 12-months post-intervention
Secondary	Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety	Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.	Baseline to Day 7 post-transplant
Secondary	Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety	Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.	Baseline to Day 14 post-transplant
Secondary	Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety	Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.	Baseline to 1-week post-intervention
Secondary	Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety	Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.	Baseline to 3-months post-intervention
Secondary	Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety	Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.	Baseline to 6-months post-intervention
Secondary	Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety	Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.	Baseline to 12-months post-intervention
Secondary	Quality of life: Changes in quality of life	Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life	Baseline to Day 7 post-transplant
Secondary	Quality of life: Changes in quality of life	Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life	Baseline to Day 14 post-transplant
Secondary	Quality of life: Changes in quality of life	Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life	Baseline to 1-week post-intervention
Secondary	Quality of life: Changes in quality of life	Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life	Baseline to 3-months post-intervention
Secondary	Quality of life: Changes in quality of life	Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life	Baseline to 6-months post-intervention
Secondary	Quality of life: Changes in quality of life	Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life	Baseline to 12-months post-intervention
Secondary	Fatigue: Changes in fatigue	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0="Not at all," 1="A little bit," 2="Somewhat," 3="Quite a bit," 4="Very much"). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.	Baseline to Day 7 post-transplant
Secondary	Fatigue: Changes in fatigue	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0="Not at all," 1="A little bit," 2="Somewhat," 3="Quite a bit," 4="Very much"). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.	Baseline to Day 14 post-transplant
Secondary	Fatigue: Changes in fatigue	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0="Not at all," 1="A little bit," 2="Somewhat," 3="Quite a bit," 4="Very much"). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.	Baseline to 1-week post-intervention
Secondary	Fatigue: Changes in fatigue	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0="Not at all," 1="A little bit," 2="Somewhat," 3="Quite a bit," 4="Very much"). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.	Baseline to 3-month post-intervention
Secondary	Fatigue: Changes in fatigue	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0="Not at all," 1="A little bit," 2="Somewhat," 3="Quite a bit," 4="Very much"). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.	Baseline to 6-month post-intervention
Secondary	Fatigue: Changes in fatigue	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0="Not at all," 1="A little bit," 2="Somewhat," 3="Quite a bit," 4="Very much"). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.	Baseline to 12-month post-intervention