NCT01487031

Brief Summary

Autologous stem cell transplant (ASCT) is an important therapy for patients with multiple myeloma, non-Hodgkin's lymphoma, and Hodgkin's lymphoma. It has been shown to improve progression free survival and overall survival. However, it is a challenging treatment process both physically and psychologically. It is a procedure with many side effects that can be uncomfortable, painful, and at times, difficult to endure. Complementary therapies, such as music therapy, have potential to be an important adjunct in palliation of symptoms in patients undergoing chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P75+ for not_applicable multiple-myeloma

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable multiple-myeloma

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

Study Start

First participant enrolled

November 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

August 2, 2013

Status Verified

July 1, 2013

Enrollment Period

1.4 years

First QC Date

December 5, 2011

Last Update Submit

July 31, 2013

Conditions

Multiple MyelomaNon-Hodgkin LymphomaHodgkin Lymphoma

Keywords

Autologous Stem Cell Transplantationmultiple myelomanon-HodgkinHodgkin lymphomaMusic TherapyNauseaPain

Outcome Measures

Primary Outcomes (2)

  • Patient perception of nausea

    Compare the difference in patient perception of nausea in those who receive music therapy and those who do not.

    7 days after intervention

  • Patient perception of pain

    Compare the difference in patient perception of pain in those who receive music therapy and those who do not.

    7 days

Secondary Outcomes (3)

  • Quality of life

    7 days

  • Use of "as needed" narcotic medications

    7 days

  • Monitoring of physiologic responsiveness

    7 days

Study Arms (2)

Music Therapy

EXPERIMENTAL

Patients randomized to receive music therapy will receive 2 sessions of live music therapy, at least 48 hours apart, from a Music Therapist-Board Certified (MT-BC, certified through the Certification Board for Music Therapists) in their room.

Other: Music Therapy

No music therapy

ACTIVE COMPARATOR

Those patients randomized to standard therapy (no music therapy) are allowed to listen to music; however they will not receive interactive music therapy from a certified therapist.

Other: No music therapy

Interventions

Music TherapyOTHER

Patients randomized to receive music therapy will receive 2 sessions of live music therapy, at least 48 hours apart, from a Music Therapist-Board Certified (MT-BC, certified through the Certification Board for Music Therapists) in their room

Music Therapy
No music therapyOTHER

Those patients randomized to standard therapy (no music therapy) are allowed to listen to music; however they will not receive interactive music therapy from a certified therapist.

No music therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be older than 18 years of age
  • Have a diagnosis of multiple myeloma, non-Hodgkin, or Hodgkin lymphoma
  • Be undergoing ASCT (Autologous Stem Cell Transplantation)

You may not qualify if:

  • Have had previous ASCT
  • Have a diagnosis of leukemia
  • History of prior music therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Multiple MyelomaLymphoma, Non-HodgkinHodgkin DiseaseNauseaPain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphomaLymphatic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Hien Duong, MD

    Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 7, 2011

Study Start

November 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

August 2, 2013

Record last verified: 2013-07

Locations

US(1)