Accelerated Phase Chronic Myelogenous LeukemiaNCT01053494

Massage Therapy Given by Caregiver in Treating Quality of Life of Young Patients Undergoing Treatment for Cancer

A study testing massage therapy, questionnaire administration and quality-of-life assessment in people with Accelerated Phase Chronic Myelogenous Leukemia and Acute Undifferentiated Leukemia, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 Read more about this study

Who is it for?: Ages 3 to 17 years
Conditions the study is for: Accelerated Phase Chronic Myelogenous Leukemia, Acute Undifferentiated Leukemia, Angioimmunoblastic T-cell Lymphoma
What is being tested?: massage therapy, questionnaire administration and quality-of-life assessment
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: Apr 2010to Feb 2012
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Signed protocol specific informed consent 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 contraindications reported by his/her attending\physician

Who cannot join

Parents/caregivers who have previously provided consistent massage for their child will be excluded from the study Child is receiving radiation only

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: The TOUCH Project: Reducing Distress and Promoting Quality of Life Via Caregiver Massage of Children Undergoing Treatment for Cancer

Read the detailed description

PRIMARY OBJECTIVES:

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.

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:

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.

Conditions: Accelerated Phase Chronic Myelogenous Leukemia, Acute Undifferentiated Leukemia, Angioimmunoblastic T-cell Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Blastic Phase Chronic Myelogenous Leukemia, Burkitt Lymphoma
Being tested: massage therapy, questionnaire administration, quality-of-life assessment, intervention by caregiver, standard follow-up care
Medical subject headings: Leukemia, Myeloid, Accelerated Phase, Leukemia, Biphenotypic, Acute, Immunoblastic Lymphadenopathy, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Blast Crisis, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Extranodal NK-T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

massage therapyProcedure or surgery
Also called massage, therapeutic massage
Undergo massage therapy
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
intervention by caregiverOther
Undergo massage by caregiver
standard follow-up careProcedure or surgery
Undergo standard follow-up care

Study groups in NCT01053494
Study group	Role	What they receive
Arm I (WAITLIST CONTROL GROUP)	Active comparator	Patients and caregivers receive standard of care and are offered the massage intervention after 8 weeks. Receives: Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: standard follow-up care
Arm II (TOUCH)	Experimental	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. Receives: Procedure: massage therapy; Other: questionnaire administration; Procedure: quality-of-life assessment; Other: intervention by caregiver
Arm III (TOUCH+)	Experimental	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. Receives: Procedure: massage therapy; Other: questionnaire administration; Procedure: quality-of-life assessment; Other: intervention by caregiver

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility and acceptability of conducting a massage intervention with childhood cancer patients and their primary caregivers
Measured: Up to 16 weeks

Secondary outcomes (3)

Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life
Measured: Baseline
Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life
Measured: Week 8
Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life
Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Feb 2012

First posted21 Jan 2010 (estimated)
Study startApr 2010
Primary completionFeb 2012
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Accelerated Phase Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01053494
Sponsor's protocol ID: IRB00011619
Other IDs: NCI-2009-01456, CCCWFU 97709
Status last verified: Jun 2018
First submitted: 20 Jan 2010
Last updated: 2 Jul 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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