NCT01053494

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

1.8 years

First QC Date

January 20, 2010

Last Update Submit

June 29, 2018

Conditions

Accelerated Phase Chronic Myelogenous LeukemiaAcute Undifferentiated LeukemiaAngioimmunoblastic T-cell LymphomaAtypical Chronic Myeloid Leukemia, BCR-ABL1 NegativeBlastic Phase Chronic Myelogenous LeukemiaBurkitt LymphomaChildhood Acute Lymphoblastic Leukemia in RemissionChildhood Acute Myeloid Leukemia in RemissionChildhood Chronic Myelogenous LeukemiaChildhood Diffuse Large Cell LymphomaChildhood Grade III Lymphomatoid GranulomatosisChildhood Immunoblastic Large Cell LymphomaChildhood Myelodysplastic SyndromesChildhood Nasal Type Extranodal NK/T-cell LymphomaChronic Eosinophilic LeukemiaChronic Myelomonocytic LeukemiaChronic Neutrophilic LeukemiaChronic Phase Chronic Myelogenous LeukemiaContiguous Stage II Mantle Cell LymphomaCutaneous B-cell Non-Hodgkin LymphomaEssential ThrombocythemiaExtramedullary PlasmacytomaIntraocular LymphomaIsolated Plasmacytoma of BoneJuvenile Myelomonocytic LeukemiaMast Cell LeukemiaMeningeal Chronic Myelogenous LeukemiaNoncontiguous Stage II Mantle Cell LymphomaPolycythemia VeraPost-transplant Lymphoproliferative DisorderPrimary MyelofibrosisPrimary Systemic AmyloidosisProgressive Hairy Cell Leukemia, Initial TreatmentProlymphocytic LeukemiaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRecurrent Childhood Anaplastic Large Cell LymphomaRecurrent Childhood Grade III Lymphomatoid GranulomatosisRecurrent Childhood Large Cell LymphomaRecurrent Childhood Lymphoblastic LymphomaRecurrent Childhood Small Noncleaved Cell LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent/Refractory Childhood Hodgkin LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Hairy Cell LeukemiaRefractory Multiple MyelomaRelapsing Chronic Myelogenous LeukemiaSecondary Acute Myeloid LeukemiaStage 0 Chronic Lymphocytic LeukemiaStage I Childhood Anaplastic Large Cell LymphomaStage I Childhood Hodgkin LymphomaStage I Childhood Large Cell LymphomaStage I Childhood Lymphoblastic LymphomaStage I Childhood Small Noncleaved Cell LymphomaStage I Chronic Lymphocytic LeukemiaStage I Cutaneous T-cell Non-Hodgkin LymphomaStage I Multiple MyelomaStage I Mycosis Fungoides/Sezary SyndromeStage II Childhood Anaplastic Large Cell LymphomaStage II Childhood Hodgkin LymphomaStage II Childhood Large Cell LymphomaStage II Childhood Lymphoblastic LymphomaStage II Childhood Small Noncleaved Cell LymphomaStage II Chronic Lymphocytic LeukemiaStage II Cutaneous T-cell Non-Hodgkin LymphomaStage II Multiple MyelomaStage II Mycosis Fungoides/Sezary SyndromeStage III Childhood Anaplastic Large Cell LymphomaStage III Childhood Hodgkin LymphomaStage III Childhood Large Cell LymphomaStage III Childhood Lymphoblastic LymphomaStage III Childhood Small Noncleaved Cell LymphomaStage III Chronic Lymphocytic LeukemiaStage III Cutaneous T-cell Non-Hodgkin LymphomaStage III Multiple MyelomaStage III Mycosis Fungoides/Sezary SyndromeStage IV Childhood Anaplastic Large Cell LymphomaStage IV Childhood Hodgkin LymphomaStage IV Childhood Large Cell LymphomaStage IV Childhood Lymphoblastic LymphomaStage IV Childhood Small Noncleaved Cell LymphomaStage IV Chronic Lymphocytic LeukemiaStage IV Cutaneous T-cell Non-Hodgkin LymphomaStage IV Mycosis Fungoides/Sezary SyndromeT-cell Large Granular Lymphocyte LeukemiaUnspecified Childhood Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • Feasibility and acceptability of conducting a massage intervention with childhood cancer patients and their primary caregivers

    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

    Baseline

  • Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life

    Week 8

  • Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life

    Week 16

Study Arms (3)

Arm I (WAITLIST CONTROL GROUP)

ACTIVE COMPARATOR

Patients and caregivers receive standard of care and are offered the massage intervention after 8 weeks.

Other: questionnaire administrationProcedure: quality-of-life assessmentProcedure: 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.

Procedure: massage therapyOther: questionnaire administrationProcedure: quality-of-life assessmentOther: 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.

Procedure: massage therapyOther: questionnaire administrationProcedure: quality-of-life assessmentOther: intervention by caregiver

Interventions

massage therapyPROCEDURE

Undergo massage therapy

Also known as: massage, therapeutic massage
Arm II (TOUCH)Arm III (TOUCH+)
questionnaire administrationOTHER

Ancillary studies

Arm I (WAITLIST CONTROL GROUP)Arm II (TOUCH)Arm III (TOUCH+)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Arm I (WAITLIST CONTROL GROUP)Arm II (TOUCH)Arm III (TOUCH+)
intervention by caregiverOTHER

Undergo massage by caregiver

Arm II (TOUCH)Arm III (TOUCH+)
standard follow-up carePROCEDURE

Undergo standard follow-up care

Arm I (WAITLIST CONTROL GROUP)

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Accelerated PhaseLeukemia, Biphenotypic, AcuteImmunoblastic LymphadenopathyLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Extranodal NK-T-CellPdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Myelomonocytic, ChronicLeukemia, Neutrophilic, ChronicLeukemia, Myeloid, Chronic-PhaseThrombocythemia, EssentialIntraocular LymphomaLeukemia, Myelomonocytic, JuvenileLeukemia, Mast-CellPolycythemia VeraPrimary MyelofibrosisImmunoglobulin Light-chain AmyloidosisLeukemia, ProlymphocyticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large-Cell, AnaplasticDendritic Cell Sarcoma, InterdigitatingLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeRecurrenceLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellMultiple MyelomaLeukemia, Large Granular Lymphocytic

Interventions

Massage

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphadenopathyMyelodysplastic-Myeloproliferative DiseasesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaLymphoma, T-CellBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersHemorrhagic DisordersEye NeoplasmsNeoplasms by SiteLeukemia, Myeloid, AcuteMastocytosis, SystemicMastocytosisMast Cell Activation DisordersBone Marrow NeoplasmsHematologic NeoplasmsNeoplasms, Plasma CellAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesParaproteinemiasHistiocytic Disorders, MalignantHistiocytosisLeukemia, B-CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesBlood Protein DisordersLeukemia, T-Cell

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Janet Tooze, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2010

First Posted

January 21, 2010

Study Start

April 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations

US(1)