Ignite Creation Date:
2024-05-06 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05147311
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2021-11-24
Brief Title:
Positive Psychology Intervention In HSCT
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Randomized Trial of a Positive Psychology Intervention for Patients With Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PATH-3
Brief Summary:
The main purpose of this research study is to determine if a positive psychology-based program in people who have received a stem cell transplant for blood cancer treatment is feasible and acceptable and can help improve positive feelings mood quality of life overall wellbeing and health
The Positive psychology for Allogenic Transplantation of Hematopoietic stem cell intervention PATH a novel 9-week phone-administered Positive psychological intervention PPI
The Positive psychology for Allogenic Transplantation of Hematopoietic stem cell intervention PATH a novel 9-week phone-administered Positive psychological intervention PPI
Detailed Description:
Low levels of positive psychological well-being PPWB eg optimism positive affect in allogeneic hematopoietic stem cell transplant HSCT recipients are common and have been associated with decreased quality of life poorer immune response and increased mortality These poor health outcomes are likely mediated through deficits in health behaviors eg medication adherence physical activity and indeed low PPWB has been prospectively associated with poorer adherence to diet medication and physical activity in other medical populations independent of sociodemographic medical comorbidity and the ill effects of depression and anxiety Positive psychological interventions PPIs could be used to promote PPWB in the allogeneic transplant population Despite the successful and effective use of PPIs in medical populations to reduce distress increase quality of life and promote health behaviors PPI have never been tested in allogeneic recipients
-This a single center randomized trial of the PATH intervention versus usual care in patients with hematologic malignancies undergoing HSCT
The research study procedures include screening for eligibility
Participants will be randomized equally to the two arms using randomized permuted blocks of sizes two and four with randomization stratified by presenceabsence of graft-versus-host disease GVHD as allogeneic transplant recipients with GVHD have significantly different courses of recovery QOL and function post transplant
Participant will be randomized into either The Positive psychology for Allogenic Transplantation of Hematopoietic stem cell intervention PATH a novel 9-week phone-administered Positive psychological intervention PPI or usual care
It is expected that about 70 people will take part in this research study
The National Institute of Health NIH National Cancer Institute NCI is supporting this research study by providing funding for the research
-This a single center randomized trial of the PATH intervention versus usual care in patients with hematologic malignancies undergoing HSCT
The research study procedures include screening for eligibility
Participants will be randomized equally to the two arms using randomized permuted blocks of sizes two and four with randomization stratified by presenceabsence of graft-versus-host disease GVHD as allogeneic transplant recipients with GVHD have significantly different courses of recovery QOL and function post transplant
Participant will be randomized into either The Positive psychology for Allogenic Transplantation of Hematopoietic stem cell intervention PATH a novel 9-week phone-administered Positive psychological intervention PPI or usual care
It is expected that about 70 people will take part in this research study
The National Institute of Health NIH National Cancer Institute NCI is supporting this research study by providing funding for the research
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K08CA251654-01 | NIH | None | httpsreporternihgovquickSearchK08CA251654-01 |