An interventional study of massage therapy and questionnaire administration in Accelerated Phase Chronic Myelogenous Leukemia, Acute Undifferentiated Leukemia and Angioimmunoblastic T-cell Lymphoma, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-07-02.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
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.
318 studies on the registry are indexed under Leukemia, Myeloid, Accelerated Phase; 12 are open to participants now.
This study's enrollment of 80 is above the median of 40 across 226 interventional studies indexed under Leukemia, Myeloid, Accelerated Phase.
Browse Leukemia, Myeloid, Accelerated Phase studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Compared within Leukemia, Myeloid, Accelerated Phase, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Signed protocol specific by the child's caregiver Assent by the child Caregiver is at least 18 years of age The child is currently treated for cancer (chemotherapy alone, radiation therapy alone, chemotherapy and radiation therapy, chemotherapy and surgery, or radiation therapy and surgery) at Wake Forest Baptist Health (WFBH) Pediatric Oncology The child has at least 16 weeks remaining on their treatment regimen The caregiver and child understand written and spoken English The child has no medical or functional reported by his/her attending\physician
Exclusion Criteria:
Parents/caregivers who have previously provided consistent massage for their child will be excluded from the study Child is receiving radiation only
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients and caregivers receive standard of care and are offered the massage intervention after 8 weeks.
Other: questionnaire administration · Procedure: quality-of-life assessment · Procedure: standard follow-up care
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.
Procedure: massage therapy · Other: questionnaire administration · Procedure: quality-of-life assessment · Other: intervention by caregiver
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.
Procedure: massage therapy · Other: questionnaire administration · Procedure: quality-of-life assessment · Other: intervention by caregiver
Undergo massage therapy
Also known as: massage, therapeutic massage
Ancillary studies
Ancillary studies
Also known as: quality of life assessment
Undergo massage by caregiver
Undergo standard follow-up care
Feasibility and acceptability of conducting a massage intervention with childhood cancer patients and their primary caregivers
Time frame: Up to 16 weeks
Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life
Time frame: Baseline
Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life
Time frame: Week 8
Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life
Time frame: Week 16
The record gives a start of Apr 2010, a primary completion of Feb 2012 and a completion of Feb 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Leukemia, Myeloid, Accelerated Phase →
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