Music Therapy or Book Discussion in Improving Quality of Life in Young Patients Undergoing Stem Cell Transplant

Malignant Neoplasm Clinical Trial

Official title:

Stories and Music for Adolescent/Young Adult Resilience During Transplant (SMART)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305851
• Other study ID #: COG-ANUR0631
• Secondary ID: NCI-2009-00408CD
• Status: Completed
• Phase: Phase 3
• Start date: April 15, 2006
• Est. completion date: March 31, 2021

Study information

• Verified date: January 2013
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized phase III trial is studying how well music therapy works compared to listening and discussing books on tape in improving quality of life in young patients undergoing stem cell transplant. Music therapy or book discussion may improve quality of life in patients undergoing stem cell transplant. It is not yet known whether music therapy is more effective than book discussion in improving quality of life in patients undergoing stem cell transplant.

Description:

PRIMARY OBJECTIVES:

I. Test the efficacy, in terms of resilience and quality of life, of a therapeutic music video (TMV) intervention vs listening and discussing books on tape (control group) for adolescents and young adults (AYA) undergoing autologous or allogeneic transplantation for cancer.

II. Qualitatively describe the perception of helpfulness and meaningfulness of a sub-group of both interventions for AYA and family members 100 days post-transplant.

OUTLINE: This is a randomized, controlled, limited multicenter study. Patients are randomized to 1 of 2 arms.

ARM I (books on tape [control group]): Patients undergo six 1-hour sessions twice a week for 3 weeks with a trained counselor in which they choose up to 3 books on CD and listen to the book and/or discuss their impressions and thoughts about the contents with the counselor. Patients are provided with a portable CD player to listen to the books during their hospitalization.

ARM II (therapeutic music video [TMV] intervention): Patients undergo six 1-hour sessions twice a week for 3 weeks with a music therapist, designed specifically for the pre-transplant and acute phase of treatment. Phases of patient participation include song writing, recording the song with a digital accompaniment track, completing a video layout worksheet, taking photos or making drawings for the video, viewing clip art and pictures on a computer, and sharing the final video with family members and hospital staff.

In both arms, patients complete questionnaires before and after sessions 2, 4, and 6 with the music therapist. Patients also complete computer-based questionnaires before hospitalization, after session six during hospitalization, and at 100 days post-transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: March 31, 2021
• Est. primary completion date: October 5, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 24 Years

Eligibility

Inclusion Criteria:

• Diagnosis of an oncology condition requiring allogeneic or autologous transplantation

• Receiving or planning to receive a myeloablative treatment regimen and 1 of the following:

• Marrow transplantation

• Peripheral stem cell transplantation

• Cord blood stem cell transplantation

• Patients with cancers that do not usually occur in childhood/adolescent or young adult populations (e.g., breast or prostate cancer) are not eligible

• Able to read and speak English

• English does not need to be the primary language

• Able to participate in the sessions as evaluated for alertness and engagement by the music therapist

• No cognitive impairments that would make it difficult to participate in the intervention or complete questionnaires

• Not married and not a parent

• Concurrent therapy for pain control or relief of other symptoms allowed

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Procedure:
• Music Therapy
Undergo therapeutic music video therapy
• Psychosocial Assessment and Care
Undergo books on tape therapy

Other:
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta - Egleston	Atlanta	Georgia
United States	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia
United States	Children's Oncology Group	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI), NIH - National Institute of Nursing Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess acute changes of Symptoms-related distress: Pain	Illness-related distress will be measured by indicators of uncertainty in illness, symptom-related distress. Brief Symptoms Assessment is a self-reported measure capturing information on pain. Specifically, the instrument includes a 1-item pain numeric rating scale.	Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
Primary	Assess acute changes of Symptoms-related distress: Anxiety	Illness-related distress will be measured by indicators of uncertainty in illness, symptom-related distress. Brief Symptoms Assessment is a self-reported measure capturing information on anxiety. Specifically, the instrument includes a 5-item Anxiety scale.	Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
Primary	Assess acute changes of Symptoms-related distress: Fatigue	Illness-related distress will be measured by indicators of uncertainty in illness, symptom-related distress. Brief Symptoms Assessment is a self-reported measure capturing information on fatigue. Specifically, the instrument includes a 1-item fatigue visual analogue scale.	Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
Primary	Assess acute changes of Symptoms-related distress: Mood	Illness-related distress will be measured by indicators of uncertainty in illness, symptom-related distress. Brief Symptoms Assessment is a self-reported measures capturing information on mood. Specifically, the instrument includes a 1-item mood scale.	Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
Primary	Assess changes in uncertainty in illness as assessed by the Mishel Uncertainty in Illness Scale	Mishel Uncertainty in Illness Scale-Revised (MUIS-R) consists of two factors: Complexity and Ambiguity, with higher scores indicating a high level of uncertainty. Item responses are on a 5-point Likert-type scale (ranging from 5 = Strongly Agree to 1 = Strongly Disagree	Change from baseline, immediately after completion of study treatment and 100 days post-transplant
Primary	Assess changes in the use of defensive coping	Defensive Coping will be measured by three subscales of the Jalowiec Coping Scale-Revised (JCS): evasive, emotive, and fatalistic coping. JCS is a self-report, 0-3 point rating scale. The items are scored for both use and effectiveness.	Change from immediately after completion of study treatment and 100 days post-transplant
Primary	Assess changes in the use of positive coping	Three subscales of the Jalowiec Coping Scale-Revised will measure Positive Coping (JCS): confrontive, optimistic, and supportive.	Change from immediately after completion of study treatment and 100 days post-transplant
Primary	Assess changes in communication with family as assessed by Parent-Adolescent Communication	Parent Adolescent Communication (P-AC) self-report items are on 5-point Likert scales that assess adolescents' views regarding their perceptions and experience of communicating with each parent rated separately. The two subscales, Open Family Communication and Problems in Family Communication, respectively measure positive and negative aspects of communications within a family and are scored independently.	Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
Primary	Assess changes in adaptability or cohesion as assessed by FACES II	Family Adaptability and Cohesion Scale II (FACES II) is a self-report scale using Likert response scales and measuring the 2 factors: Adaptability or cohesion	Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
Primary	Assess changes in perceived social support from friends	Perceived Social Support from Friends (PSS-Fr) is a self-report scale using 3-point rating responses ranging from 0 to 2 designed to measure the extent to which individuals perceive that their needs for support, information, and feedback are fulfilled by friends.	Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
Primary	Assess changes in perceived social support from family	Perceived Social Support from Family (PSS-Fa) is a self-report, 3-point response (Yes, No, I don't know) scale, designed to measure the extent to which individuals perceive that their needs for support, information and feedback are fulfilled by family.	Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
Primary	Assess changes in perceived social support from healthcare providers	Perceived Social Support from Health Care Providers (PSS-HCP) is a self-report, 3-point rating scale adapted by Haase from items on the Perceived Social Support-Friends scales102 to correspond to health care provider relationships. Items indicate the extent to which individuals perceive their needs for support, information, and feedback are fulfilled by health care providers.	Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
Primary	Assess changes in Hope from stem cell transplantation (STC) experience:	Measured by indicators of hope. Herth Hope Index (HHI) items are on a 4-point scale, ranging from 1 (strongly disagree) to 4 (strongly agree); higher summative scores indicate greater hope.	Change from immediately after completion of study treatment, and 100 days post-transplant
Primary	Assess changes in Spiritual Perspective from stem cell transplantation (STC) experience	Measured by indicators spiritual perspective. Reed Spiritual Perspective Scale (RSPS) is a one-factor scale that measures the saliency of spiritual beliefs and behaviors in the respondent's life.157 The response format is a 6-point Likert scale anchored with words describing the frequency of behaviors.	Change from immediately after completion of study treatment, and 100 days post-transplant
Primary	Assess changes of Higher Resilience: Haase Adolescent Resilience in Cancer Scale	Haase Adolescent Resilience in Cancer Scale measures resilience related to illness. The scale uses a 6-point Likert-type scale ranging form: 1 (strongly disagree) to 4 (strongly agree); higher summative scores indicate greater resilience. Validity of the scales was found in predictive correlations with self-esteem, self-transcendence, confidence/mastery and quality of life. In Haase's preliminary studies, alpha reliability coefficients were 0.84 - 0.86.	Change from after completion of study treatment and 100 days post-transplant
Primary	Assess changes of Higher Resilience (self esteem, confidence, self-transcendence): NCS	Nowotny Confidence Subscale (NCS) of the Nowotny Hope Scale is a self-report of confidence in one's own ability, which uses a 4-point Likert response format of strongly agree to strongly disagree	Change from after completion of study treatment, and 100 days post-transplant
Primary	Assess changes of Higher Resilience (self esteem, confidence, self-transcendence): STS	Reed Self-Transcendence Scale (STS) assesses activities and perspectives individuals engage in to expand their boundaries via 4-point Likert response scales	Change from after completion of study treatment, and 100 days post-transplant
Primary	Assess changes in Higher Resilience (self esteem, confidence, self-transcendence): SES	Rosenberg Self-esteem Scale (SES) measures attitudes toward one's self. Responses are on a 4-point Likert scale.	Change from after completion of study treatment, and 100 days post-transplant
Primary	Assess changes in indicators of well-being and global quality of life: LASA Uniscale	Measured by indicators of well-being and global quality of life.LASA Uniscale is a global QOL self-report one-item instrument: "Please score how you feel your life has been affected by the state of your health (any disease or treatment) during the last week".160 The item is adopted from the Southwest Oncology Group protocol, which adapted the scale from a linear analogue to categorical format with 5 response categories ranging from extremely unpleasant to normal (no change).	Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
Primary	Assess changes in indicators of well-being and global quality of life: IWB	Measured by indicators of well-being and global quality of life. Index of Well-being (IWB) is a semantic differential scale describing present life using adjective extremes such as discouraging/hopeful.	Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
Secondary	Qualitatively describe the perception of helpfulness and meaningfulness of both the low-dose and TMV interventions for AYA and family members	The Interview Guide is used to collect data to answer research questions. The interview schedule includes open-ended questions. Examples of questions for the TMV group AYA and designated caregiver, respectively, are: "Tell me about your experience of being involved in the music video production" and "Tell me what you think it meant for your adolescent to complete the video." (Appendix 1) The interview proceeds until the participant feels the experience is fully described	100 days post-transplant