Malignant NeoplasmPhase 3NCT00305851
Music Therapy or Book Discussion in Improving Quality of Life in Young Patients Undergoing Stem Cell Transplant
A Phase 3 study testing Music Therapy, Psychosocial Assessment and Care and Quality-of-Life Assessment in people with Malignant Neoplasm, run by Children's Oncology Group at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 11 to 24 years
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Music Therapy, Psychosocial Assessment and Care 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
- 118 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Apr 2006to 31 Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 11 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Children's Oncology Group
Philadelphia, Pennsylvania, 19104
About this study
Official title: Stories and Music for Adolescent/Young Adult Resilience During Transplant (SMART)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Malignant Neoplasm
- Being tested
- Music Therapy, Psychosocial Assessment and Care, Quality-of-Life Assessment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyProcedure or surgery
Undergo therapeutic music video therapy
Psychosocial Assessment and CareProcedure or surgery
Also called Psychosocial Care/Assessment
Undergo books on tape therapy
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (counseling) | Active comparator | 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. Receives: Procedure: Psychosocial Assessment and Care; Other: Quality-of-Life Assessment |
| Arm II (counseling and music therapy) | Experimental | 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. Receives: Procedure: Music Therapy; Procedure: Psychosocial Assessment and Care; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
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.
Measured: Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
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.
Measured: Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
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.
Measured: Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
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
Measured: Change from baseline, immediately after completion of study treatment and 100 days post-transplant
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.
Measured: Change from immediately after completion of study treatment and 100 days post-transplant
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.
Measured: Change from immediately after completion of study treatment and 100 days post-transplant
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.
Measured: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
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
Measured: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
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.
Measured: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
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.
Measured: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
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.
Measured: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
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.
Measured: Change from immediately after completion of study treatment, and 100 days post-transplant
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.
Measured: Change from immediately after completion of study treatment, and 100 days post-transplant
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.
Measured: Change from after completion of study treatment and 100 days post-transplant
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
Measured: Change from after completion of study treatment, and 100 days post-transplant
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
Measured: Change from after completion of study treatment, and 100 days post-transplant
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.
Measured: Change from after completion of study treatment, and 100 days post-transplant
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).
Measured: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
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.
Measured: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
Secondary outcomes (1)
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
Measured: 100 days post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study start15 Apr 2006
- Primary completion5 Oct 2010
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Joan E Haase, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305851
- Sponsor's protocol ID
- COG-ANUR0631
- Other IDs
- NCI-2009-00408, CDR0000463879, COG-ANUR0631, COG-ANUR0631, ANUR0631, R01NR008583, U10CA095861
- Status last verified
- Jan 2013
- First submitted
- 21 Mar 2006
- Last updated
- 15 Jul 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stories and Music for Adolescent/Young Adult Resilience During Transplant (SMART)
- ClinicalTrials.gov ID
- NCT00305851
- Acronym / sponsor ID
- COG-ANUR0631
- Conditions
- Malignant Neoplasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI), National Institute of Nursing Research (NINR)
- Study start
- 15 Apr 2006 (actual)
- Primary completion
- 5 Oct 2010 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 22 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (counseling) | Active comparator | Procedure: Psychosocial Assessment and Care, Other: Quality-of-Life AssessmentPatients 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 (counseling and music therapy) | Experimental | Procedure: Music Therapy, Procedure: Psychosocial Assessment and Care, Other: Quality-of-Life AssessmentPatients 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. |
Who may qualify
- Ages
- 11 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Diagnosis of an oncology condition requiring allogeneic or autologous transplantation
- Receiving or planning to receive a myeloablative treatment regimen and 1 of the following:
- 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
- Able to participate in the sessions as evaluated for alertness and engagement by the music therapist
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyUndergo therapeutic music video therapy | Procedure or surgery | Arm II (counseling and music therapy) |
| Psychosocial Assessment and CareAlso: Psychosocial Care/AssessmentUndergo books on tape therapy | Procedure or surgery | Arm I (counseling), Arm II (counseling and music therapy) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (counseling), Arm II (counseling and music therapy) |
Primary outcome
Assess acute changes of Symptoms-related distress: Pain
Time frame: Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
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.
Assess acute changes of Symptoms-related distress: Anxiety
Time frame: Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
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.
Assess acute changes of Symptoms-related distress: Fatigue
Time frame: Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
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.
Assess acute changes of Symptoms-related distress: Mood
Time frame: Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
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.
Assess changes in uncertainty in illness as assessed by the Mishel Uncertainty in Illness Scale
Time frame: Change from baseline, immediately after completion of study treatment and 100 days post-transplant
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
Assess changes in the use of defensive coping
Time frame: Change from immediately after completion of study treatment and 100 days post-transplant
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.
Assess changes in the use of positive coping
Time frame: Change from immediately after completion of study treatment and 100 days post-transplant
Three subscales of the Jalowiec Coping Scale-Revised will measure Positive Coping (JCS): confrontive, optimistic, and supportive.
Assess changes in communication with family as assessed by Parent-Adolescent Communication
Time frame: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
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.
Assess changes in adaptability or cohesion as assessed by FACES II
Time frame: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
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
Assess changes in perceived social support from friends
Time frame: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
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.
Assess changes in perceived social support from family
Time frame: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
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.
Assess changes in perceived social support from healthcare providers
Time frame: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
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.
Assess changes in Hope from stem cell transplantation (STC) experience:
Time frame: Change from immediately after completion of study treatment, and 100 days post-transplant
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.
Assess changes in Spiritual Perspective from stem cell transplantation (STC) experience
Time frame: Change from immediately after completion of study treatment, and 100 days post-transplant
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.
Assess changes of Higher Resilience: Haase Adolescent Resilience in Cancer Scale
Time frame: Change from after completion of study treatment and 100 days post-transplant
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.
Assess changes of Higher Resilience (self esteem, confidence, self-transcendence): NCS
Time frame: Change from after completion of study treatment, and 100 days post-transplant
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
Assess changes of Higher Resilience (self esteem, confidence, self-transcendence): STS
Time frame: Change from after completion of study treatment, and 100 days post-transplant
Reed Self-Transcendence Scale (STS) assesses activities and perspectives individuals engage in to expand their boundaries via 4-point Likert response scales
Assess changes in Higher Resilience (self esteem, confidence, self-transcendence): SES
Time frame: Change from after completion of study treatment, and 100 days post-transplant
Rosenberg Self-esteem Scale (SES) measures attitudes toward one's self. Responses are on a 4-point Likert scale.
Assess changes in indicators of well-being and global quality of life: LASA Uniscale
Time frame: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
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).
Assess changes in indicators of well-being and global quality of life: IWB
Time frame: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
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.
1 secondary outcome
Qualitatively describe the perception of helpfulness and meaningfulness of both the low-dose and TMV interventions for AYA and family members
Time frame: 100 days post-transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan E Haase principal investigator
Children's Oncology Group
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Music Therapy, Psychosocial Assessment and Care and Quality-of-Life Assessment in people with Malignant Neoplasm, run by Children's Oncology Group at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess acute changes of Symptoms-related distress: Pain (time frame: Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.