Positive Psychology for Bone Marrow Transplant Survivors
(PATH-4 Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Brigham and Women's Hospital
Disqualifiers: Benign hematologic conditions, Outpatient HSCT, Severe psychiatric or cognitive conditions
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This randomized clinical trial is evaluating the impact of a positive psychology intervention (PATH) on anxiety symptoms, depression symptoms, and quality of life in survivors of hematopoietic stem cell transplant (HSCT) compared to usual care.
Do I need to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment PATH, MATCH, PATH 2.0 for bone marrow transplant survivors?
Research shows that positive psychology interventions, like the PATH treatment, are feasible and acceptable for bone marrow transplant survivors, with small-to-medium improvements in patient-reported outcomes. Positive psychological constructs, such as optimism, have been linked to better health outcomes in similar medical populations.12345
Is the Positive Psychology intervention safe for bone marrow transplant survivors?
How is the PATH treatment different from other treatments for bone marrow transplant survivors?
The PATH treatment is unique because it uses positive psychology interventions (PPIs) delivered over the phone to improve psychological well-being in bone marrow transplant survivors, focusing on exercises like writing gratitude letters to enhance positive emotions, which is not a standard approach in this context.12568
Eligibility Criteria
This trial is for adults over 18 who have had a bone marrow transplant (allogeneic HSCT) and are about 100 days post-transplant. They must be able to communicate in English or Spanish and have access to a phone. It's not for those with benign hematologic conditions, outpatient HSCT, or severe psychiatric issues like dementia.Inclusion Criteria
I am an adult who had a stem cell transplant from a donor and it's been almost 100 days since.
Access to a basic telephone
I can speak, read, and understand English or Spanish for study needs.
Exclusion Criteria
I have undergone a stem cell transplant as an outpatient.
Patients with severe psychiatric or cognitive conditions, such as dementia, determined by their transplant oncologist to make them unable to provide informed consent or comply with study procedures
I had a stem cell transplant from a donor for a non-cancer blood condition.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the PATH intervention focused on gratitude, strengths, and meaning, with exercises on goal-setting and tracking daily physical activity
10 weeks
Questionnaires completed in person, over the computer or telephone, or by mail at predetermined days
Follow-up
Participants are monitored for psychological distress and quality of life improvements using validated assessment tools
Up to 40 weeks
Treatment Details
Interventions
- PATH (Behavioral Intervention)
Trial OverviewThe study is testing the PATH program, which uses positive psychology techniques to see if it can improve anxiety, depression symptoms, and life quality after bone marrow transplant compared to usual care. Participants will be randomly assigned to either receive PATH or continue with their standard follow-up.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Positive Affect in the Transplantation of Hematopoietic Stem Cells (PATH)Experimental Treatment1 Intervention
Participants recruited from the Dana-Farber Cancer Institute, Duke Cancer Institute, and Moffitt Cancer Center who are randomized to the intervention/experimental arm will receive the PATH intervention, which is focused on gratitude, strengths, and meaning, as well as focused exercises on goal-setting and tracking daily physical activity.
Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol.
Group II: Usual CareActive Control1 Intervention
Participants recruited from the Dana-Farber Cancer Institute, Duke Cancer Institute, and Moffitt Cancer Center who are randomized to the usual care arm will receive their usual support from the HSCT team, including all routine supportive care resources (e.g., support from social work) offered by the HSCT team.
Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Moffitt Cancer CenterTampa, FL
Duke Cancer InstituteDurham, NC
Dana Farber Cancer InstituteBoston, MA
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Who Is Running the Clinical Trial?
Brigham and Women's HospitalLead Sponsor
Dana-Farber Cancer InstituteCollaborator
Duke UniversityCollaborator
H. Lee Moffitt Cancer Center and Research InstituteCollaborator
References
A positive psychology intervention to promote health outcomes in hematopoietic stem cell transplantation: the PATH proof-of-concept trial. [2023]Allogeneic hematopoietic stem cell transplantation (HSCT) recipients often experience deficits in positive psychological well-being (PPWB) due to intensive treatment and follow-up care. Positive psychology interventions (PPIs) that promote PPWB via deliberate and systematic exercises (e.g., writing a gratitude letter) have consistently improved PPWB in medical populations, yet have never been studied in early HSCT recovery. In this single-arm, proof-of-concept study, we assessed the feasibility and acceptability of a novel eight-session, telephone-delivered PPI in early HSCT recovery. A priori, we defined feasibility as >50% of eligible patients enrolling in the study and >50% of participants completing 5/8 sessions, and acceptability as mean ease and utility scores of weekly participant ratings of PP exercises as 7/10. Of 45 eligible patients, 25 (55.6%) enrolled, 20 (80%) completed baseline assessments, 15 (75%) started the intervention, and 12 (60%) completed the intervention and follow-up assessments. The intervention was feasible (55.6% of eligible participants enrolled; 60% of baseline assessment completers finished 5/8 sessions) and led to very small-to-medium effect-size improvements in patient-reported outcomes. A novel, eight-week, telephone-delivered PPI was feasible and acceptable in allogeneic HSCT recipients. Larger, randomized studies are needed to examine the efficacy of PPIs for improving outcomes in this population.
Positive psychological experiences in allogeneic hematopoietic stem cell transplantation. [2020]Positive psychological constructs (e.g., optimism and hope) have been associated with superior health outcomes in the recovery from hematopoietic stem cell transplantation (HSCT) in prior work. However, such studies have not examined a broad range of positive psychological constructs, their sources or evolution over time, or their connections with key health behaviors. We used semistructured qualitative interviews in 25 HSCT patients to explore the nature and sources of positive psychological experiences during the first 100 days after transplantation.
Positive Psychological Constructs and Health Outcomes in Hematopoietic Stem Cell Transplantation Patients: A Systematic Review. [2019]Positive psychological constructs (eg, optimism, positive affect) have been independently associated with superior health outcomes across many medical populations. However, there has been little synthesis of the literature examining these associations among patients with hematologic malignancies receiving hematopoietic stem cell transplantation (HSCT). To address this gap we completed a systematic review, using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, of studies examining relationships between positive psychological constructs and health-related outcomes (eg, psychiatric symptoms, function, health-related quality of life [HRQoL], or treatment compliance) after HSCT. Eighteen eligible studies (N = 4201; 47% women; mean age, 47.1) were identified. Optimism (n = 12 studies) was the most frequently studied positive construct and HRQoL (examined in n = 11 studies) the most common outcome. All 17 studies with quantitative analyses found a significant (P
Personal changes, dispositional optimism, and psychological adjustment to bone marrow transplantation. [2019]We investigated the number and direction of personal changes experienced by long-term survivors of bone marrow transplantation (BMT) and the relationships of those changes and dispositional optimism to psychological adjustment (current and future life satisfaction and mood). Surveys were returned by 86.0% (N = 135) of all eligible long-term survivors; respondents primarily were young males who were 6 to 149 months post-BMT. Subjects reported more positive changes in the relationship and existential/psychological domains and more negative changes in the physical health domain; there was no difference on the plans/activities domain. Negative changes were more strongly related to adjustment than were positive changes. The number of negative changes reported was significantly related to current and future life satisfaction and negative mood after controlling for demographic and illness variables and dispositional optimism. The interaction term for negative and positive changes was significantly related to future life satisfaction after controlling for all other variables.
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. [2021]During, shortly after, and sometimes for years after hematopoietic stem cell transplant, a large proportion of hematological cancer patients undergoing transplant report significant physical and psychological symptoms and reduced health-related quality of life. To address these survivorship problems, we developed a low-burden, brief psychological intervention called expressive helping that includes two theory- and evidence-based components designed to work together synergistically: emotionally expressive writing and peer support writing. Building on evidence from a prior randomized control trial showing reductions in physical symptoms and distress in long-term transplant survivors with persistent survivorship problems, the Writing for Insight, Strength, and Ease (WISE) trial will evaluate the efficacy of expressive helping when used during transplant and in the early post-transplant period, when symptoms peak, and when intervention could prevent development of persistent symptoms.
Positive Psychological Well-Being in Hematopoietic Stem Cell Transplantation Survivors. [2023]Positive thoughts and emotions contribute to overall psychological health in diverse medical populations, including patients undergoing HSCT. However, few studies have described positive psychological well-being (eg, optimism, gratitude, flourishing) in patients undergoing HSCT using well-established, validated patient-reported outcome measures. We conducted cross-sectional secondary analyses of baseline data in 156 patients at 100 days post-HSCT enrolled in a randomized controlled trial of a psychological intervention (ClinicalTrials.gov identifier NCT05147311) and a prospective study assessing medication adherence at a tertiary care academic cancer center from September 2021 to December 2022. We used descriptive statistics to outline participant reports of positive psychological well-being (PPWB) using validated measures for optimism, gratitude, positive affect, life satisfaction, and flourishing. The participants had a mean age of 57.4 ± 13.1 years, and 51% were male (n = 79). Many, but not all, participants reported high levels of PPWB (ie, optimism, gratitude, positive affect, life satisfaction, and flourishing), defined as agreement with items on a given PPWB measure. For example, for optimism, 29% of participants did not agree that "overall, I expect more good things to happen to me than bad." Aside from life satisfaction, mean PPWB scores were higher in the HSCT population than in other illness populations. Although many patients with hematologic malignancies undergoing HSCT report high levels of PPWB, a substantial minority of patients reported low PPWB (i.e., no agreement with items on a given PPWB measure). Because PPWB is associated with important clinical outcomes in medical populations, further research should determine whether an intervention to promote PPWB can improve quality of life in HSCT recipients.
Do negative or positive emotions differentially impact mortality after adult stem cell transplant? [2006]Multiple diverse biomedical variables have been shown to affect outcome after hematopoietic stem cell transplantation (HSCT). Whether psychosocial variables should be added to the list is controversial. Some empirical reports have fueled skepticism about the relationship between behavioral variables and HSCT survival. Most of these reports have methodological shortcomings. Their samples were small in size and included heterogeneous patient populations with different malignant disease and disease stages. Most data analyses did not control adequately for biomedical factors using multivariate analyses. The pre-transplant evaluations differed from study to study, making cross-study generalizations difficult. Nevertheless, a few recently published studies challenge this skepticism, and provide evidence for deleterious effects of depressive symptomatology on HSCT outcome. This mini review integrates the new data with previously reviewed data, focusing on the differential impact of negative and positive emotional profiles on survival. Pre-transplant negative emotional profiles are associated with worse survival in the long term, whereas pre-transplant optimism about transplant appears to affect survival in the short term. These data have practical implications for transplant teams. Pre-transplant psychological evaluation should assess for specific adverse behavioral risk factors, particularly higher levels of depression and lower levels of optimistic expectations about transplant. Transplant centers should develop collaborative studies to further test the effects of these adverse behavioral risk factors, and run multicenter hypothesis-driven clinical trials of psychological intervention protocols. Such studies should aim to better define pragmatics of assessment and intervention (timing, assessment tools, personnel), and evaluate their contribution to improving outcome after transplant.
A systematic review of psychosocial factors affecting survival after bone marrow transplantation. [2022]An electronic database search identified 15 studies of psychosocial factors affecting survival after bone marrow transplantation. The studies were assessed for methodological quality by two reviewers using the procedures of Bland and colleagues. Although some studies found that psychological variables affect survival after bone marrow transplantation, the reviewers' analysis of the methodologically sound studies suggested that survival after bone marrow transplantation is not substantively affected by depressed mood or other psychopathology in adults or by social support in adults or children. Longer survival may be related to lower "anxious preoccupation," higher "fighting spirit," and better quality of life ratings before and soon after transplant in adults. Overall, however, the literature is insufficiently developed to provide definitive evidence for a relationship between psychological variables and survival after bone marrow transplantation. Future primary studies in this area should be designed to maximize replicability and generalizability.