Stem Cell TransplantationPhase 3NCT03800758
Expressive Helping for Stem Cell Transplant Patients
A Phase 3 study testing Expressive Helping and Factual Writing in people with Stem Cell Transplantation and Hematologic Malignancy, run by Northwestern University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stem Cell Transplantation, Hematologic Malignancy
- What is being tested?
- Expressive Helping and Factual Writing
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Mar 2019to 24 Apr 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients
- Age ≥ 18
- English proficient
- Scheduled for allogeneic or autologous transplant at JTCC, LCCC, or RHLCC.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Randomized Controlled Trial Testing Expressive Helping for Stem Cell Transplant Patients
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.
Read the 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.
- Conditions
- Stem Cell Transplantation, Hematologic Malignancy
- Being tested
- Expressive Helping, Factual Writing
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive HelpingBehavioural
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 WritingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Factual Writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 12-months post-intervention
Secondary outcomes (34)
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.
Measured: Baseline to Day 7 post-transplant
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.
Measured: Baseline to Day 14 post-transplant
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.
Measured: Baseline to 1-week 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.
Measured: Baseline to 6-months post-intervention
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.
Measured: Baseline to Day 7 post-transplant
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.
Measured: Baseline to Day 14 post-transplant
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.
Measured: Baseline to 1-week post-intervention
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.
Measured: Baseline to 3-months post-intervention
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.
Measured: Baseline to 6-months post-intervention
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.
Measured: Baseline to 12-months post-intervention
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.
Measured: Baseline to Day 7 post-transplant
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.
Measured: Baseline to Day 14 post-transplant
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.
Measured: Baseline to 1-week post-intervention
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.
Measured: Baseline to 3-months post-intervention
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.
Measured: Baseline to 6-months post-intervention
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.
Measured: Baseline to 12-months post-intervention
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.
Measured: Baseline to Day 7 post-transplant
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.
Measured: Baseline to Day 14 post-transplant
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.
Measured: Baseline to 1-week post-intervention
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.
Measured: Baseline to 3-months post-intervention
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.
Measured: Baseline to 6-months post-intervention
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.
Measured: Baseline to 12-months post-intervention
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
Measured: Baseline to Day 7 post-transplant
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
Measured: Baseline to Day 14 post-transplant
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
Measured: Baseline to 1-week post-intervention
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
Measured: Baseline to 3-months post-intervention
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
Measured: Baseline to 6-months post-intervention
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
Measured: Baseline to 12-months post-intervention
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.
Measured: Baseline to Day 7 post-transplant
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.
Measured: Baseline to Day 14 post-transplant
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.
Measured: Baseline to 1-week post-intervention
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.
Measured: Baseline to 3-month post-intervention
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.
Measured: Baseline to 6-month post-intervention
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.
Measured: Baseline to 12-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start6 Mar 2019
- Primary completion24 Apr 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Lombardi Comprehensive Cancer Center, Hackensack Meridian Health
- Responsible party
- Principal investigator, Christine Rini, PhD, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800758
- Sponsor's protocol ID
- PRO2018-0953
- Other IDs
- R01CA223963, 2018-1306
- Status last verified
- May 2023
- First submitted
- 8 Jan 2019
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All IPD will be protected and maintained by the study team
Publications
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.
PubMed 34670600
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Testing Expressive Helping for Stem Cell Transplant Patients
- ClinicalTrials.gov ID
- NCT03800758
- Acronym / sponsor ID
- PRO2018-0953
- Conditions
- Stem Cell Transplantation, Hematologic Malignancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Lombardi Comprehensive Cancer Center, Hackensack Meridian Health
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expressive Helping writing | Experimental | Behavioral: Expressive HelpingWriting 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. |
| Factual Writing | Active comparator | Behavioral: Factual WritingWriting 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer patients
- Age ≥ 18
- English proficient
- Scheduled for allogeneic or autologous transplant at JTCC, LCCC, or RHLCC.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive HelpingExpressive 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. | Behavioural | Expressive Helping writing |
| Factual WritingFactual 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. | Behavioural | Factual Writing |
Primary outcome
Symptom severity: Changes in symptom burden
Time frame: Baseline to 3-months post intervention
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.
Symptom severity: Changes in symptom burden
Time frame: Baseline to 12-months post-intervention
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.
34 secondary outcomes
Symptom severity: Changes in symptom burden
Time frame: Baseline to Day 7 post-transplant
Symptom severity: Changes in symptom burden
Time frame: Baseline to Day 14 post-transplant
Symptom severity: Changes in symptom burden
Time frame: Baseline to 1-week post-intervention
Symptom severity: Changes in symptom burden
Time frame: Baseline to 6-months post-intervention
Depressive symptoms: Changes in depressive symptoms
Time frame: Baseline to Day 7 post-transplant
Depressive symptoms: Changes in depressive symptoms
Time frame: Baseline to Day 14 post-transplant
Depressive symptoms: Changes in depressive symptoms
Time frame: Baseline to 1-week post-intervention
Depressive symptoms: Changes in depressive symptoms
Time frame: Baseline to 3-months post-intervention
Depressive symptoms: Changes in depressive symptoms
Time frame: Baseline to 6-months post-intervention
Depressive symptoms: Changes in depressive symptoms
Time frame: Baseline to 12-months post-intervention
Generalized Anxiety: Changes in symptoms of generalized anxiety
Time frame: Baseline to Day 7 post-transplant
Generalized Anxiety: Changes in symptoms of generalized anxiety
Time frame: Baseline to Day 14 post-transplant
Generalized Anxiety: Changes in symptoms of generalized anxiety
Time frame: Baseline to 1-week post-intervention
Generalized Anxiety: Changes in symptoms of generalized anxiety
Time frame: Baseline to 3-months post-intervention
Generalized Anxiety: Changes in symptoms of generalized anxiety
Time frame: Baseline to 6-months post-intervention
Generalized Anxiety: Changes in symptoms of generalized anxiety
Time frame: Baseline to 12-months post-intervention
Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
Time frame: Baseline to Day 7 post-transplant
Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
Time frame: Baseline to Day 14 post-transplant
Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
Time frame: Baseline to 1-week post-intervention
Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
Time frame: Baseline to 3-months post-intervention
Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
Time frame: Baseline to 6-months post-intervention
Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
Time frame: Baseline to 12-months post-intervention
Quality of life: Changes in quality of life
Time frame: Baseline to Day 7 post-transplant
Quality of life: Changes in quality of life
Time frame: Baseline to Day 14 post-transplant
Quality of life: Changes in quality of life
Time frame: Baseline to 1-week post-intervention
Quality of life: Changes in quality of life
Time frame: Baseline to 3-months post-intervention
Quality of life: Changes in quality of life
Time frame: Baseline to 6-months post-intervention
Quality of life: Changes in quality of life
Time frame: Baseline to 12-months post-intervention
Fatigue: Changes in fatigue
Time frame: Baseline to Day 7 post-transplant
Fatigue: Changes in fatigue
Time frame: Baseline to Day 14 post-transplant
Fatigue: Changes in fatigue
Time frame: Baseline to 1-week post-intervention
Fatigue: Changes in fatigue
Time frame: Baseline to 3-month post-intervention
Fatigue: Changes in fatigue
Time frame: Baseline to 6-month post-intervention
Fatigue: Changes in fatigue
Time frame: Baseline to 12-month post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 34670600Whitmore 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.
- Individual participant dataSharing planned: No. All IPD will be protected and maintained by the study team
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Expressive Helping and Factual Writing in people with Stem Cell Transplantation and Hematologic Malignancy, run by Northwestern University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom severity: Changes in symptom burden (time frame: Baseline to 3-months post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03800758, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.