Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
The TOUCH Project: Reducing Distress and Promoting Quality of Life Via Caregiver Massage of Children Undergoing Treatment for Cancer
This clinical trial studies massage therapy given by caregiver in treating quality of life of young patients undergoing treatment for cancer. Massage therapy given by a caregiver may improve the quality of life of young patients undergoing treatment for cancer
PRIMARY OBJECTIVES:
I. To determine the feasibility and acceptability of conducting a massage intervention with
childhood cancer patients and their primary caregivers.
II. To investigate feasibility of implementing a brief targeted massage training protocol
with caregivers.
III. To identify barriers to recruitment, intervention adherence, and full study completion
by consented families.
IV. To assess preliminary effectiveness of the massage intervention in reducing caregiver and
child psychological distress (anxiety, depression, parenting stress) and promoting child
health-related quality of life.
V. To compare outcome data between two intervention arms (TOUCH: child massage only; TOUCH+:
Caregiver massage plus child massage) and between each arm and a wait list control condition.
VI. To utilize the pilot data in a development of contextually specific and targeted grant
application for a fully powered randomized controlled trial of the efficacy of caregiver
massage of children undergoing treatment for cancer.
SECONDARY OBJECTIVES:
I. To investigate reciprocal change in self-reported psychosocial functioning within the
caregiver-child dyad from baseline to post-intervention.
II. To assess impact of massage intervention upon levels of a stress biomarker (cortisol) in
caregivers and children and to assess associations of cortisol levels with self-reported
psychosocial functioning.
OUTLINE: Patients and their caregivers are randomized to 1 of 3 treatment arms.
ARM I (WAITLIST CONTROL GROUP): Patients and caregivers receive standard of care and are
offered the massage intervention after 8 weeks.
ARM II (TOUCH): Caregivers undergo a 60-minute training session on simple massage techniques,
including the "Massage Toolkit," comprising Swedish Massage and Trigger Point Therapy
Massage, at week 0 and a booster 60-minute massage training session at week 4 with a licensed
massage therapist. Caregivers are instructed to massage their children for at least 3
20-minute sessions per week for 8 weeks.
ARM III (TOUCH+): Caregivers undergo a 60-minute training session on simple massage
techniques, including the "Massage Toolkit," comprising Swedish Massage and Trigger Point
Therapy Massage, at week 0 and a booster 60-minute massage training session at week 4 with a
licensed massage therapist. Caregivers are instructed to massage their children for at least
3 20-minute sessions per week for 8 weeks. Caregivers also receive a 45-minute massage by the
massage therapist.
Patients complete questionnaires at weeks 0, 8, and 16.
After completion of study treatment, patients and caregivers are followed for 8 weeks.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT04093570 -
A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers
|
Phase 2 | |
| Active, not recruiting |
NCT03289910 -
Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia
|
Phase 2 | |
| Not yet recruiting |
NCT05895201 -
High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Sitagliptin for the Prevention of GVHD
|
Phase 1/Phase 2 | |
| Completed |
NCT01427881 -
Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies
|
Phase 2 | |
| Recruiting |
NCT01133886 -
Use of Decitabine in Myelodysplastic Syndrome (MDS) Following Azacitidine (AZA) Failure
|
Phase 2 | |
| Completed |
NCT01233921 -
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
|
N/A | |
| Completed |
NCT01169012 -
PK Study of Oral and IV Clofarabine in High Risk Myelodysplasia+Acute Leukemias
|
Phase 1 | |
| Terminated |
NCT00509249 -
Aflibercept in Treating Patients With Myelodysplastic Syndromes
|
Phase 2 | |
| Completed |
NCT01093586 -
Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|
Phase 2 | |
| Terminated |
NCT00387426 -
Sunitinib in Treating Patients With Idiopathic Myelofibrosis
|
Phase 2 | |
| Completed |
NCT00096122 -
Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
| Completed |
NCT00171912 -
Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes
|
Phase 2 | |
| Completed |
NCT00078858 -
Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
| Completed |
NCT00052520 -
Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome, Acute or Chronic Myeloid Leukemia, or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03683433 -
Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation
|
Phase 2 | |
| Recruiting |
NCT04980404 -
Inqovi Maintenance Therapy in Myeloid Neoplasms
|
Phase 1 | |
| Active, not recruiting |
NCT03588078 -
Study of the Safety and Efficacy of APR-246 in Combination With Azacitidine
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT06085638 -
Phase I/II Study of SY-1425 (Tamibarotene) in Combination With Azacitidine and Venetoclax for Patients With Chronic Myelomonocytic Leukemia
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03999723 -
Combining Active and Passive DNA Hypomethylation
|
Phase 2 | |
| Terminated |
NCT00852709 -
Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias
|
Phase 1 |