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Hematologic Diseases

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.

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.

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

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

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.

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.

Expressive Helping for Stem Cell Transplant Patients

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

All IPD will be protected and maintained by the study team

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.

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.

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.

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.

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

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.

National Cancer Institute (NCI)

Lombardi Comprehensive Cancer Center

Hackensack Meridian Health

Northwestern University

Director, Cancer Survivorship Institute, Robert H. Lurie Comprehensive Cancer Center

Participants complete a 20-minute expressive writing session once per week for the first three weeks. During Week 4, participants complete a 20-minute peer support writing session.

Participants complete a 20-minute expressive writing session once per week for four weeks.

Participants complete a 20-minute factual writing about their cancer diagnosis and treatment every week for four weeks.

Expressive helping involves a combination of emotional disclosure and peer support writing completed over four weeks.

Expressive writing involves emotional disclosure writing over four weeks.

Expressive Writing

Factual writing involves writing facts about cancer treatment and experiences over four weeks.

William Tsai, PhD

William Tsai

The Chinese American Cancer Survivors Writing Study is a Randomized Controlled Trial (RCT) testing the feasibility and efficacy of the Expressive Helping (EH) intervention among Chinese American cancer survivors.

Chinese Americans are one of the fastest growing immigrant groups in the United States, but there is still a lack of culturally-sensitive and linguistically-appropriate resources and interventions for this group. To address this gap, the investigators will examine the efficacy and feasibility of Expressive Helping, a writing intervention designed to lead participants to write about their cancer experiences. Participants will be adult cancer survivors of Chinese descent. After screening and consent, eligible participants will be enrolled in a 1:1:1 randomized controlled trial. Assessments of psychological symptoms will occur at baseline (prior to randomization), 1-month post-intervention, 3-months post-intervention, and 6-months post-intervention.

Chinese American Cancer Survivors Writing Study

A Randomized Controlled Trial Testing Expressive Helping for Chinese American Cancer Survivors

The number of participants screened for eligibility, percent eligible to participate, and percent of people who refuse to participate will be tracked.

Percent of participants who complete each stage of the study (e.g., baseline survey, writing sessions, follow-ups) will be tracked.

Assessed by dividing the number of writing sessions finished by the number of sessions assigned.

Depressive symptoms will be measured with the 10-item Center for Epidemiologic Studies Depression Scale (CES-D). The score can range from 0-30 and higher scores indicate more depressive symptoms.

Anxiety symptoms will be measured with the 7-item GAD-7 scale (Spitzer et al., 2006). This scale measures generalized anxiety symptoms in the past 7 days, has score ranges from 0-21 with higher scores indicating greater anxiety symptoms.

Health-related quality of life will be measured by the 27-item FACT-G, which assess four domains: physical well-being, social well-being, emotional well-being and functional well-being. The score ranges from 0-108 with higher scores indicating better quality of life.

Perceived stress is measured by the 10-item Perceived Stress Scale (PSS). The score ranges from 0-40 with higher scores indicating higher perceived stress.

Cancer-related fatigue is measured by the 13-item Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT). The score ranges from 0-52 with higher scores indicating greater fatigue.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Expressive Helping for Stem Cell Transplant Patients	NCT03800758	Stem Cell Trans... Hematologic Mal...	Expressive Help... Factual Writing	18 Years -	Northwestern University
Chinese American Cancer Survivors Writing Study	NCT05456100	Cancer	Expressive Help... Expressive Writ... Factual Writing	18 Years - 80 Years	New York University
Expressive Helping for Stem Cell Transplant Patients	NCT03800758	Stem Cell Trans... Hematologic Mal...	Expressive Help... Factual Writing	18 Years -	Northwestern University

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