Hematologic Malignancy Clinical Trial
— PATH-COfficial title:
Randomized Controlled Trial of a Positive Psychology Based Intervention (PATH-C) for Caregivers of Hematopoietic Stem Cell Transplant Survivors
The goal of this randomized clinical trial is to evaluate whether a positive psychology intervention (PATH-C) can improve psychological well-being, quality of life, and physical activity in caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT).
Status | Recruiting |
Enrollment | 80 |
Est. completion date | January 31, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult caregivers (aged 18 years and older) of patients undergoing allogeneic or autologous HSCT at Dana-Farber Cancer Institute for a hematologic malignancy. - A relative or a friend who either lives with the patient or has in-person contact with them at least twice per week and is identified as the primary caregiver for HSCT. - Ability to speak English and able to complete questionnaires with minimal assistance of an interpreter as this is a feasibility trial of the PATH-C intervention which is currently only available in English. Exclusion Criteria: - Caregivers of patients undergoing HSCT for benign hematologic conditions. - Caregivers with acute or unstable psychiatric conditions which the treating transplant clinician believes prohibits informed consent or compliance with study procedures. - Cognitive deficits impeding a caregiver's ability to provide informed consent or participate adequately in the study assessed via a commonly used 6-item cognitive assessment with the Brief Interview for Mental Status (BIMS) screening tool that is sensitive and specific for screening for cognitive impairment in research participants. |
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | American Society of Hematology, Dana-Farber Cancer Institute, Robert Wood Johnson Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Optimism | Compare optimism using the 10-item Life Orientation Test-Revised (LOT-R) between the two groups. The LOT-R ranges from 0 to 24, with higher scores indicating greater optimism. |
Up to 20 weeks (+/- 28 days) | |
Other | Positive Affect | Compare positive affect using the 15-item PROMIS Positive Affect Short Form between the two groups. The PROMIS Positive Affect Short Form ranges from 15 to 75, with higher scores indicating greater positive affect. |
Up to 20 weeks (+/- 28 days) | |
Other | Life Satisfaction | Compare life satisfaction using the 10-item PROMIS General Life Satisfaction Questionnaire between the two groups. The PROMIS General Life Satisfaction Questionnaire ranges from 10 to 60, with higher scores indicating greater satisfaction with life. |
Up to 20 weeks (+/- 28 days) | |
Other | Gratitude | Compare gratitude using the 6-item Gratitude Questionnaire between the two groups. The Gratitude Questionnaire ranges from 6 to 42, with higher scores indicating a stronger propensity for experiencing gratitude in daily life. |
Up to 20 weeks (+/- 28 days) | |
Other | Flourishing | Compare flourishing using the 8-item Flourishing Scale between the two groups. The Flourishing Scale ranges from 8 to 56, with higher scores indicating having more psychological resources and strengths. |
Up to 20 weeks (+/- 28 days) | |
Other | Self-Efficacy | Compare self-efficacy using the Cancer Self-Efficacy Scale-transplant (CASE-t) between the two groups. The CASE-t ranges from 0 to 170, with higher scores indicating greater self-efficacy. |
Up to 20 weeks (+/- 28 days) | |
Other | Perceived Coping Skills | Compare coping skills using the Measure of Current Status (MOCS-A) between the two groups. The MOCS-A ranges from 0 to 52, with higher scores indicating having more coping skills. |
Up to 20 weeks (+/- 28 days) | |
Other | Stress Resilience | Compare stress resilience using the 6-item Brief Resilience Scale (BRS) between the two groups. The BRS ranges from 6 to 30, with higher scores indicating greater stress resilience. |
Up to 20 weeks (+/- 28 days) | |
Other | Locus of Control | Compare locus of control using the Multidimensional Health Locus of Control (MHLC) scale, Form A between the two groups. The MHLC Form A ranges from 6 to 36 for each locus of control category (internal, powerful others, or chance), and higher scores suggest greater belief in each category as the source of health locus of control. |
Up to 20 weeks (+/- 28 days) | |
Primary | PATH-C Intervention Feasibility | PATH-C Intervention Feasibility is defined as >60% of eligible participants enrolling in the study and >60% of enrolled participants who start the intervention completing at least 6/9 intervention sessions. | Up to 10 weeks | |
Secondary | PATH-C Intervention Acceptability | Acceptability will be measured using weekly ratings of the ease and utility of each exercise (0=very difficult/not helpful; 10=very easy/very helpful) and will use a threshold of a mean combined score of 7.0/10.0. | Up to 10 weeks | |
Secondary | Physical activity longitudinally based on ActiGraph GT3X+ accelerometer | Compare physical activity levels using the ActiGraph GT3X+ accelerometer between the two groups. Greater steps/day and lower sedentary leisure time indicate greater physical activity. |
Up to 20 weeks (+/- 28 days) | |
Secondary | Caregiver Quality of Life based on the CarGOQOL | Compare caregiver quality of life using the 29-item CareGiver Oncology Quality of Life questionnaire (CarGOQOL) between the two groups. Higher scores on the CarGOQOL (normalized score range, 1-100) indicate better quality of life. |
Up to 20 weeks (+/- 28 days) | |
Secondary | Anxiety Symptoms based on the HADS-Anxiety Subscale | Compare anxiety symptoms using the 7-item Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale between the two groups. The HADS-A subscale ranges from 0-21, with higher scores indicating worse anxiety symptoms. |
Up to 20 weeks (+/- 28 days) | |
Secondary | Depression Symptoms based on the HADS-Depression Subscale | Compare depression symptoms using the 7-item Hospital Anxiety and Depression Scale-Depression (HADS-D) subscale between the two groups. The HADS-D subscale ranges from 0-21, with higher scores indicating worse depression symptoms. |
Up to 20 weeks (+/- 28 days) | |
Secondary | Caregiving Burden based not the Caregiver Reaction Assessment (CRA) | Compare caregiving burden using the 24-item Caregiver Reaction Assessment (CRA) between the two groups. The CRA ranges from 24 to 120, with higher scores indicating greater caregiving burden. |
Up to 20 weeks (+/- 28 days) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Recruiting |
NCT04889937 -
Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population
|
||
Not yet recruiting |
NCT05820126 -
Cold Versus Room Temperature Storage of Platelets for Bleeding in Hematologic Malignancy - a Pilot Trial
|
Phase 2 | |
Active, not recruiting |
NCT04509765 -
A Phase II Single-arm Study of Total Body Irradiation With Linac Based VMAT and IGRT
|
N/A | |
Not yet recruiting |
NCT06350994 -
Early Assessment of Cardiac Function After Treatment With CAR-T Cells
|
||
Withdrawn |
NCT04282174 -
CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies
|
Phase 2 | |
Not yet recruiting |
NCT05443854 -
Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)
|
Phase 3 | |
Withdrawn |
NCT03986086 -
MPH966 for Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
|
Phase 1/Phase 2 | |
Completed |
NCT02512666 -
Non Invasive Optical Imaging of WBC Count
|
N/A | |
Not yet recruiting |
NCT02193399 -
Physiotherapy in Hematopoietic Stem Cell Transplantation
|
N/A | |
Withdrawn |
NCT02207764 -
Reiki as a Complementary Therapy: A Pilot Study
|
N/A | |
Terminated |
NCT01846429 -
Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
|
Phase 1 | |
Terminated |
NCT01215981 -
Influenza Vaccine Post Allogeneic Transplant
|
N/A | |
Completed |
NCT00333190 -
CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation
|
N/A | |
Withdrawn |
NCT04392128 -
Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE)
|
Phase 2 | |
Recruiting |
NCT06102213 -
Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation
|
Phase 2 | |
Active, not recruiting |
NCT04552288 -
Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies
|
Phase 2 | |
Completed |
NCT03654404 -
A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients
|
N/A | |
Recruiting |
NCT05384288 -
Response to Influenza Vaccination in Pediatric Oncology Patients
|
||
Recruiting |
NCT05084027 -
Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT
|
Phase 2 |