Hematologic Malignancy Clinical Trial
— PATH-3Official title:
Randomized Trial of a Positive Psychology Intervention for Patients With Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation
Verified date | November 2023 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 70 |
Est. completion date | March 31, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Adult patients (= 18 years) with hematologic malignancies who have received allogeneic HSCT at Dana Farber Cancer Institute who are approaching 100-day post-transplant milestone. - Ability to speak, read and write English. - Access to a telephone. Exclusion Criteria: - Cognitive deficits impeding a study participant's ability to provide informed consent or participate adequately in the study procedures assessed via a commonly used 6-item cognitive assessment with the Brief Interview for Mental Status (BIMS). - Medical conditions precluding interviews. - Patients undergoing HSCT for benign hematologic conditions. - Patients undergoing outpatient HSCT. - Patients with psychiatric or cognitive conditions which the treating clinicians believes prohibits compliance with study procedures. - Patients who are unable to verbally consent or are not yet adults (including infants, children, teenagers), pregnant women, or prisoners. |
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mean Fatigue Score | The Patient Reported Outcome Measurement Information System-Fatigue-8a (PROMIS-Fatigue-8a) questionnaire will be used to assess fatigue by cohort. The 8 item questionnaire is scored 0-5 for each item for a total of 0-40. A higher score indicates higher levels of fatigue. A mean score will be presented for each cohort. | At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration | |
Other | Mean Overall Function Score | A mean overall function score will be generated for each cohort using a 20-item Patient-Reported Outcomes Measurement Information System-Physical Function-20 (PROMIS-PF-20) with each item scored from 5 to 1 for a total of 100 possible points; higher scores indicate better physical function. | At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration | |
Other | Mean Anxiety and Depression Score | Hospital Anxiety and Depression Scale (HADS) to assess symptoms of depression and anxiety in all study participants. The HADS is a 14-item questionnaire (two 7-item subscales assessing depression and anxiety symptoms during the past week). The questionnaire consists of a four-point item response form that quantifies the degree to which participants experience mood symptoms. Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety or depression. The mean anxiety and depression score will be reported for each cohort. | At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration | |
Other | Mean Post Traumatic Stress Disorder Checklist | The mean score for post-traumatic stress disorder (PTSD) will be reported by cohort. It will be evaluated using the Post-Traumatic Stress Disorder Checklist (PCL) to assess symptoms of post-traumatic stress in patients. The PCL is a 17 item self-reported measure that evaluates symptoms of post-traumatic stress disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders-IV. Each item is scored from 1-5 for a total of 185 potential points. A higher score indicates higher levels of PTSD. | At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration | |
Other | Mean Optimism Score | The 7-item Life Orientation Test-Revised (LOT-R) will be used to measure dispositional (trait) optimism. Each item is scored from 1-5 for a total of 35 points possible. Higher scores indicate greater optimism. A mean score will be reported for each cohort. | At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration | |
Other | Mean Positive Affect Score | The 10-item Positive and Negative Affect Schedule (PANAS) will be used to measure positive affect; higher scores indicate greater positive and negative affect. Each item is scored from 1-5 for a total of 50 points possible. A mean score will be reported for each cohort. | At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration | |
Other | Mean Social Support Score | The 26-item Social Support Effectiveness Questionnaire (SSEQ), a validated instrument used in oncological population, will be used to assess patients' perception of social support. A mean score will be reported for each cohort. Higher scores indicate more effective support. Full scale scores can range from 0 to 80.
Items 1, 6, and 11 -- responses are scored: Very poor = 0, Poor = 1, Fair = 2, Good = 3, Excellent = 4 Items 2, 7, and 12 - responses are scored: Not at all = 4, a little bit = 3, moderately = 2, quite a bit = 1, extremely = 0 Items 3, 8, and 13 - responses are scored: Not at all = 0, a little bit = 1, moderately = 2, quite a bit = 3, extremely = 4 Items 4, 9, and 14 - responses are scored: Never = 4, rarely = 3, sometimes = 2, often = 1, always = 0 Items 5, 10, and 15 - responses are scored: Never = 0, rarely = 1, sometimes = 2, often = 3, always = 4 Items 16 through 25 - responses are scored: Yes = 0, no = 2 |
At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration | |
Other | Mean Coping Score | The Brief Cope, a 28-item questionnaire will be used to assess 14 methods of coping (e.g., self-distraction, humor, denial) using a 4-point Likert scale. Each Item is scored from 1-4 for a total of 112 points possible, with a higher score indicating better coping. A mean score will be reported for each cohort. | At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration | |
Other | Mean Minutes of Light Activity per Day | Minutes per day of light activity will be measured using the well-validated Actigraph GT3X+ accelerometer. It will be work for 7 days (at least 4) on the week it is given to the subject. Ten or more ours of recorded data per day for at least four days is the minimum requirement for each use. A mean score will be reported for each cohort. | At baseline (registration) and then week 9 and week 18 from the time of registration | |
Other | Mean Sedentary Leisure Time per Day | Sedentary leisure time per day will be measured using the well-validated Actigraph GT3X+ accelerometer. It will be work for 7 days (at least 4) on the week it is given to the subject. Ten or more ours of recorded data per day for at least four days is the minimum requirement for each use A mean score will be reported for each cohort.. | At baseline (registration) and then week 9 and week 18 from the time of registration | |
Other | Mean Immunosuppressant Adherence Rate | Medication (specifically immunosuppressant, tacrolimus or sirolimus) adherence will be measured via the widely used electronic pill monitoring system, MEMS Caps to electronically monitor immunosuppressant adherence over the duration of the study. From the electronic health records and confirmed by patients, will determine immunosuppressant medication and dosing, and will calculate changes in adherence over time (% of medication correctly taken, by week and month), based on MEMS data. A mean percent will be given for each cohort. | Weekly from baseline, up to 18 weeks | |
Other | Mean Self-Reported Tacrolimus Adherence Score | Self-reported adherence to Tacrolimus (an immunosuppressant medication which all allogeneic HSCT patients must take) will be measured using the Medication Adherence Reporting Scale (MARS-5). This is a 5 item questionnaire, each scored from 1-5. A higher score indicates a higher level of adherence to medication. The entire questionnaire is out of 20. A mean score will be reported for each cohort. | At baseline (registration) and then week 9 and week 18 from the time of registration | |
Other | Mean Satisfaction Score | Satisfaction will be measured by Satisfaction with Life Scale (SWLS). This 5 item questionnaire will measure satisfaction with life; higher scores indicate greater satisfaction with life. Each item will be scored from 1-7; the entire questionnaire will be scored from 5-35. A mean score will be reported for each cohort. | At baseline (registration) and then week 9 and week 18 from the time of registration | |
Other | Mean Gratitude Score | The 6-item Gratitude questionnaire (GQ-6) measures dispositional gratitude; higher scores indicate greater proneness to experience gratitude in daily life. Each item will be scored from 1-7; the entire questionnaire will be scored from 6-42. A mean score will be reported for each cohort. | At baseline (registration) and then week 9 and week 18 from the time of registration | |
Other | Mean Flourishing Score | The 8-item Flourishing Scale measures a person's self-perceived success in critical areas such as engagement, relationships, self-esteem, meaning & purpose, and optimism; higher scores indicate many psychological resources and strengths. Each item will be scored from 1-7; the entire questionnaire will be scored from 8-56. A mean score will be reported for each cohort. | At baseline (registration) and then week 9 and week 18 from the time of registration | |
Primary | Feasibility Rate | Proportion of patients completing at least 6 of the 9 positive psychology (PP) sessions, which are phone delivered in the interventional cohort. Positive psychology (PP) sessions are interventions that encourage patients to perform simple, enjoyable activities as well as encourage gratitude, strengths, and life purpose. | Weekly after randomization, up to 9 weeks | |
Primary | Acceptability Rate | Mean combined score of post PP session survey for the interventional cohort. Immediately after the completion of the weekly session, participants will rate the ease of exercise completion, overall utility of the exercise, and current levels of positive affect (0=very difficult/not helpful; 10=very easy/very helpful). The mean ease and utility of each exercise and overall will be calculated, and a mean score out of 10.0 will be calculated. | Weekly after randomization, up to 9 weeks | |
Secondary | Mean Quality of Life Scores | 45-item Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) to assess quality of life (QOL) by cohort. The FACT-BMT consists of five subscales assessing well-being across four domains (physical, functional, emotional, social, and bone marrow transplant symptoms). Each question is scored from 0 ("Not at all") to 4 ("Very Much"). The final score will be presented as a percentage, calculated by tallying the total score out of 180. A higher score coincides with a better quality of life. | At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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 | |
Withdrawn |
NCT02207764 -
Reiki as a Complementary Therapy: A Pilot Study
|
N/A | |
Not yet recruiting |
NCT02193399 -
Physiotherapy in Hematopoietic Stem Cell Transplantation
|
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 |