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حالة التجربة السريرية NCT06328127 (PATH-4) لـ زراعة الخلايا الجذعية المكونة للدم هي قيد التجنيد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.
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Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors (PATH-4)

قيد التجنيد
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT06328127 (PATH-4) هي دراسة تدخُّلية لـزراعة الخلايا الجذعية المكونة للدم وهي قيد التجنيد. بدأت في ١٦ جمادى الآخرة ١٤٤٦ هـ مع خطة لتجنيد ٤٠٠ مشاركًا. يقودها مستشفى بريغهام والنساء، ومن المتوقع اكتمالها بحلول ٢٨ محرم ١٤٥٢ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢٢ جمادى الأولى ١٤٤٧ هـ.
الملخص
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.
وصف مفصل
Patients undergoing hematopoietic stem cell transplantation (HSCT) deal with numerous physical and psychological symptoms during acute hospitalization and recovery. Of the few psychosocial interventions tailored to the needs of the HSCT population, most focus on the needs of patients in the pre-transplant phase or during the HSCT hospitalization, but not during the acute recovery period starting at 100-days post-HSCT. Hence, the investigators developed a remotely-delivered positive psychology intervention, Positive Affect in the Transplantation of Hematopoietic Stem Cells (PATH). This intervention encourages patients to perform simple and enjoyable structured activities that increase the intensity of positive thoughts and emotions. With this multi-site randomized clinical trial, the investigators aim to find out whether PATH can improve psychological distress and quality of life in HSCT survivors, compared to usual care, using validated assessment tools.
العنوان الرسمي

Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors

الحالات الطبية
زراعة الخلايا الجذعية المكونة للدم
معرّفات دراسة أخرى
  • PATH-4
  • 23-691
NCT معرّف
NCT06328127
تاريخ البدء (فعلي)
2024-12-17
آخر تحديث مُنشور
2025-11-13
تاريخ الاكتمال (المقدر)
2030-05-31
عدد المشاركين المخطط لهم
٤٠٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
قيد التجنيد
الكلمات الرئيسية
stem cell transplant
positive psychology intervention
الغرض الأساسي
الرعاية الداعمة
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
لا شيء (مفتوحة)
مجموعات/التدخلات
مجموعة المشاركين/مجموعةتَدَخُّل/علاج
تجريبيةPositive Affect in the Transplantation of Hematopoietic Stem Cells (PATH)
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.
PATH
PATH, a phone-delivered positive psychology intervention for patients who have undergone HSCT, consists of three 3-week modules. The first module focuses on gratitude and physical activity goal setting. The second module focuses on personal strengths and resources to enhance daily physical activity. The third module focuses on meaning and assessing barriers to physical activity. The third week of each module is an integration exercise dedicated to help participants explore practical ways of incorporating the themes for the given module into daily life. A trained interventionist will guide participants to complete each 30-minute weekly session.
بدون تدخلUsual Care
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.
غ/م
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
Compare anxiety symptoms between the two groups at 10 weeks using the 7-item Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A). The HADS-A subscale ranges from 0-21, with higher scores indicating worse anxiety symptoms.
10 weeks
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
Compare anxiety symptoms longitudinally between the two groups using the 7-item Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale. The HADS-A subscale ranges from 0-21, with higher scores indicating worse anxiety symptoms.
Up to 40 weeks
Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale
Compare depression symptoms longitudinally between the two groups using the 7-item Hospital Anxiety and Depression Scale-Depression (HADS-D) subscale. The HADS-D subscale ranges from 0-21, with higher scores indicating worse depression symptoms.
Up to 40 weeks
Gratitude based on the Gratitude Questionnaire
Compare gratitude longitudinally between the two groups using the 6-item Gratitude Questionnaire. The Gratitude Questionnaire ranges from 6-42, with higher scores indicating a stronger propensity for experiencing gratitude in daily life.
Up to 40 weeks
Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale
Compare positive affect longitudinally between the two groups using the 10-item Positive and Negative Affect Schedule (PANAS) Positive Affect Subscale. The PANAS Positive Affect Subscale ranges from 10-50, with higher scores indicating higher levels of positive affect.
Up to 40 weeks
Physical function based on the Patient-Reported Outcomes Measurement Information System-Physical Function-20
Compare physical function longitudinally between the two groups using the 20-item Patient-Reported Outcomes Measurement Information System-Physical Function-20 (PROMIS-PF-20). The PROMIS-PF-20 ranges from 20 to 100, with higher scores indicating better physical functioning.
Up to 40 weeks
Patient-Reported Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
Compare quality of life longitudinally between the two groups using the 47-item Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT). The FACT-BMT consists of 5 subscales assessing well-being across the following domains: physical, functional, emotional, social, and bone marrow transplant symptoms. The FACT-BMT ranges from 0-148, with higher scores indicating better quality of life.
Up to 40 weeks
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
  • Adult patients (aged 18 years and older) undergoing allogeneic HSCT and are approaching 100-days post-HSCT
  • Ability to speak, read, and respond to questions in English or Spanish to complete study procedures
  • Access to a basic telephone

  • Patients who underwent allogeneic HSCT for benign hematologic conditions
  • 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
Brigham and Women's Hospital logoمستشفى بريغهام والنساء392 تجارب سريرية نشطة للاستكشاف
الجهة المسؤولة عن الدراسة
Hermioni L.Amonoo, MD, MPP, MPH, المحقق الرئيسي, Director, Well-Being and Cancer Research Program, Brigham and Women's Hospital
جهة اتصال مركزية للدراسة
جهة اتصال: Hermioni Amonoo, MD, MPP, MPH, 617-525-7472, [email protected]
جهة اتصال: Isabella Larizza, BSc, [email protected]
3 مواقع الدراسة في 1 بلدان

Florida

Moffitt Cancer Center, Tampa, Florida, 33612, United States
Heather Jim, PhD, جهة اتصال, [email protected]
قيد التجنيد

Massachusetts

Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Hermioni Amonoo, MD, MPP, MPH, جهة اتصال, 617-525-7472, [email protected]
Hermioni Amonoo, MD, MPP, MPH, المحقق الرئيسي
قيد التجنيد

North Carolina

Duke Cancer Institute, Durham, North Carolina, 27710, United States
Thomas LeBlanc, MD, جهة اتصال, [email protected]
قيد التجنيد