CancerPINPOINTNCT03085927
Mechanisms of Active Music Engagement to Improve Health Outcomes of Children With Cancer and Parents
A study testing Active Music Engagement and Audio Storybooks in people with Cancer, run by Indiana University at 4 sites in United States.
Trial summary
Music therapy, a frequently used arts-based therapy, has become standard palliative care in many pediatric and adult hospitals; however, few studies have examined the mechanisms by which music therapy interventions work. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Cancer
- What is being tested?
- Active Music Engagement and Audio Storybooks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Sep 2016to 6 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages 3-8 years inclusive.
- Expected treatment course for at least 3 days to receive chemotherapy and/or radiation therapy.
- A consistent parent who can be present for all sessions.
Who cannot join
- Child and/or parent do not speak English.
- Child has a significant cognitive impairment that hinders participation (based on physician judgment).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46202
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64155
About this study
Music therapy, a frequently used arts-based therapy, has become standard palliative care in many pediatric and adult hospitals; however, few studies have examined the mechanisms by which music therapy interventions work. This study investigates behavioral, social, and psychological factors that may explain how an Active Music Engagement (AME) intervention (i.e., an interactive, music-based play intervention) works to manage emotional distress and improve positive health outcomes in parents and young children with cancer during treatment. Findings will provide scientific and clinically relevant practice knowledge to guide delivery of music therapy as a complementary therapy.
Read the detailed description
Music therapy, a frequently used arts-based therapy, has become standard palliative care in many pediatric and adult hospitals; however, few studies have examined mechanisms by which music therapy interventions work.Based on the Contextual Support Model of Music Therapy, the investigators developed and tested the Active Music Engagement (AME) intervention, establishing it as a feasible and acceptable intervention that reduces emotional distress in young children (ages 3-8) hospitalized for cancer treatment.Emotional distress in young children with cancer during acute treatment and their parents is a prevalent,persistent problem associated with physical symptom distress and diminished quality of life and family function. The music therapist-led AME uses music-based play and parent education/support (music play resource kit; tip sheets), is easy to implement, and teaches parents/children how to therapeutically use a familiar activity to manage distress. The purpose of this two group randomized controlled trial is to identify behavioral, sociological, and psychological variables contributing to positive outcomes observed in previous AME studies (i.e., mediators) and identify for whom the intervention works (i.e., moderators). The investigators will examine proximal mediators of child engagement and parent-child interaction and distal mediators of perceived family normalcy, parent confidence (self-efficacy) about their ability to support their child during treatment, and independent parent/child use of music and play activities to manage distress during hospitalization. The investigators hypothesize these factors mediate change in outcomes of child emotional distress, physical symptom distress, and quality of life; parent emotional/traumatic distress and quality of life; and family function. Specific aims are to examine: 1) effects of proximal and distal mediators of AME on young child/parent outcomes; 2) moderators of AME on young child/parent distress; 3) explore child physical symptom distress (pain, fatigue, nausea) in mediation and moderation models. Child/parent dyads (n=184) will be stratified by age and randomized in blocks of 6 to AME or audio-storybooks; each group will receive three 45-minute sessions with a credentialed music therapist for 3 consecutive days with data collection at baseline, post-intervention, and 30 days later. Mediation effects will be estimated using ANCOVA, fitting appropriate mediation models using MPlus and then testing indirect effects using the percentile bootstrap approach to estimate indirect effect. Moderation effects will be tested by including appropriate interaction terms of the potential moderator with the intervention indicator in our models.
- Conditions
- Cancer
- Being tested
- Active Music Engagement, Audio Storybooks
- Keywords
- music therapy, neoplasms, play, children, parents
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Music EngagementBehavioural
Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. During the first visit, parent and child will receive information on common responses of young children to cancer treatment and how parents can use music play activities to support their child during treatment. The music therapist will lead parent and child in a variety of music play activities. Parent and child will receive a music kit that includes items such as hand-held rhythm instruments, puppets, and a music CD. During the second and third visit the music therapist will lead parent and child child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home.
Audio StorybooksBehavioural
Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1-Active Music Engagement | Experimental | Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. During the first visit, parent and child will receive information on common responses of young children to cancer treatment and how parents can use music play activities to support their child during treatment. The music therapist will lead parent and child in a variety of music play activities. Parent and child will receive a music kit that includes items such as hand-held rhythm instruments, puppets, and a music CD. During the second and third visit the music therapist will lead parent and child child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home. Receives: Behavioral: Active Music Engagement |
| Arm II- Audio-Storybooks | Experimental | Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration. Receives: Behavioral: Audio Storybooks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Normalcy Perspective - Family Management Measure (FaMM)
Family Normalcy is assessed through The Family Management Measure (FaMM) - Family Life Difficulty Subscale includes 14-items rated on a 5-point Likert-type scale. Subscale items address parents' perceptions of the extent to which having a child with a chronic condition makes family life difficult. Higher values indicate more difficulty managing the condition. Score range 14 - 70.
Measured: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
Parent Self-Efficacy - Parental Beliefs Scale (PBS).
Parent Self-Efficacy is assessed through the Parental Beliefs Scale (PBS) for Hospitalized Children, a 20-item scale that measures parental beliefs about their confidence in anticipating changes in their hospitalized child's behavior and confidence in their parental role during hospitalization. Scores range from 20-100, with higher scores indicating more positive beliefs.
Measured: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
Child Emotional Distress - Child Health Questionnaire (CHQ)
Child Emotional Distress is assessed through the Child Health Questionnaire (CHQ-PF98) Mental Health Subscale (Landgraf et al., 1999). This subscale consists of 16 items rated on a 5-point Likert-scale. Scores range from 16 to 80 with lower scores indicating better mental health.
Measured: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
Child Quality of Life - KINDL.
Child Quality of Life is assessed through the KINDL Questionnaire for Measuring Health-Related Quality of Life in Children. The KINDL consists of 24 parent-report items rated on a 5-point Likert-scale for each subscale. Scores range from 20-100 with higher scores indicating better quality of life.
Measured: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
Parent Emotional and Traumatic Stress Symptoms - Profile of Mood States-Short Form (POMS).
Parent Emotional and Traumatic Distress was assessed through the Profile of Mood States - Short Form (POMS-SF) which measures mood disturbance. There are 37 items which respondents rate on a 5-point Likert scale. Scores range from 0 to 148 with higher scores indicating greater mood disturbance.
Measured: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
Parent Emotional and Traumatic Stress Symptoms - Impact of Events Scale-Revised (IES-R)
Stress Symptoms assessed through the Impact of Events Scale-Revised (IES-R), a 22-item measure that measures traumatic stress symptoms in response to a traumatic event that is specified in the instructions. Parents respond to each item using a 5-point Likert scale. Scores range from 0 to 12 with higher scores indicating greater traumatic stress symptoms.
Measured: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
Parent Quality of Life - Index of Well Being.
Parent Quality of Life is assessed through the Index of Well-being, a 9-item semantic differential scale describing present life using adjective extremes. Scores range from 7 to 63 with higher scores meaning greater well-being.
Measured: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
Family Function - Family Adaptability and Cohesion Scale (FACES II).
Family Function is assessed through the Family Adaptability and Cohesion Scale II (FACES II), a 30-item scale of items rated using a 5-point Likert scale. Scores range from 1 to 5, with higher scores meaning higher family adaptability and cohesion.
Measured: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start26 Sep 2016
- Primary completion6 Apr 2020
- Study completion6 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta, Children's Mercy Hospital Kansas City, M.D. Anderson Cancer Center
- Responsible party
- Principal investigator, Sheri Robb, Indiana University
- Investigators
- Sheri L Robb, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085927
- Sponsor's protocol ID
- R01NR015789
- Acronym
- PINPOINT
- Status last verified
- Oct 2021
- First submitted
- 27 Feb 2017
- Last updated
- 11 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robb SL, Clair AA, Watanabe M, Monahan PO, Azzouz F, Stouffer JW, Ebberts A, Darsie E, Whitmer C, Walker J, Nelson K, Hanson-Abromeit D, Lane D, Hannan A. A non-randomized [corrected] controlled trial of the active music engagement (AME) intervention on children with cancer. Psychooncology. 2008 Jul;17(7):699-708. doi: 10.1002/pon.1301.
PubMed 18033724Robb SL, Haase JE, Perkins SM, Haut PR, Henley AK, Knafl KA, Tong Y. Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer. J Pediatr Psychol. 2017 Mar 1;42(2):208-219. doi: 10.1093/jpepsy/jsw050.
PubMed 27289068Robb SL. The effect of therapeutic music interventions on the behavior of hospitalized children in isolation: developing a contextual support model of music therapy. J Music Ther. 2000 Summer;37(2):118-46. doi: 10.1093/jmt/37.2.118.
PubMed 10932125Robb SL, Stegenga K, Perkins SM, Stump TE, Moody KM, Henley AK, MacLean J, Jacob SA, Delgado D, Haut PR. Mediators and Moderators of Active Music Engagement to Reduce Traumatic Stress Symptoms and Improve Well-being in Parents of Young Children With Cancer. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231218266. doi: 10.1177/15347354231218266.
PubMed 38145309
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Active Music Engagement to Improve Health Outcomes of Children With Cancer and Parents
- ClinicalTrials.gov ID
- NCT03085927
- Acronym / sponsor ID
- PINPOINT / R01NR015789
- Conditions
- Cancer
- Keywords
- music therapy, neoplasms, play, children, parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta, Children's Mercy Hospital Kansas City, M.D. Anderson Cancer Center
- Study start
- 26 Sep 2016 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Posted 11 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Music therapy, a frequently used arts-based therapy, has become standard palliative care in many pediatric and adult hospitals; however, few studies have examined the mechanisms by which music therapy interventions work. This study investigates behavioral, social, and psychological factors that may explain how an Active Music Engagement (AME) intervention (i.e., an interactive, music-based play intervention) works to manage emotional distress and improve positive health outcomes in parents and young children with cancer during treatment. Findings will provide scientific and clinically relevant practice knowledge to guide delivery of music therapy as a complementary therapy.
Detailed description
Music therapy, a frequently used arts-based therapy, has become standard palliative care in many pediatric and adult hospitals; however, few studies have examined mechanisms by which music therapy interventions work.Based on the Contextual Support Model of Music Therapy, the investigators developed and tested the Active Music Engagement (AME) intervention, establishing it as a feasible and acceptable intervention that reduces emotional distress in young children (ages 3-8) hospitalized for cancer treatment.Emotional distress in young children with cancer during acute treatment and their parents is a prevalent,persistent problem associated with physical symptom distress and diminished quality of life and family function. The music therapist-led AME uses music-based play and parent education/support (music play resource kit; tip sheets), is easy to implement, and teaches parents/children how to therapeutically use a familiar activity to manage distress. The purpose of this two group randomized controlled trial is to identify behavioral, sociological, and psychological variables contributing to positive outcomes observed in previous AME studies (i.e., mediators) and identify for whom the intervention works (i.e., moderators). The investigators will examine proximal mediators of child engagement and parent-child interaction and distal mediators of perceived family normalcy, parent confidence (self-efficacy) about their ability to support their child during treatment, and independent parent/child use of music and play activities to manage distress during hospitalization. The investigators hypothesize these factors mediate change in outcomes of child emotional distress, physical symptom distress, and quality of life; parent emotional/traumatic distress and quality of life; and family function. Specific aims are to examine: 1) effects of proximal and distal mediators of AME on young child/parent outcomes; 2) moderators of AME on young child/parent distress; 3) explore child physical symptom distress (pain, fatigue, nausea) in mediation and moderation models. Child/parent dyads (n=184) will be stratified by age and randomized in blocks of 6 to AME or audio-storybooks; each group will receive three 45-minute sessions with a credentialed music therapist for 3 consecutive days with data collection at baseline, post-intervention, and 30 days later. Mediation effects will be estimated using ANCOVA, fitting appropriate mediation models using MPlus and then testing indirect effects using the percentile bootstrap approach to estimate indirect effect. Moderation effects will be tested by including appropriate interaction terms of the potential moderator with the intervention indicator in our models.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1-Active Music Engagement | Experimental | Behavioral: Active Music EngagementThree 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. During the first visit, parent and child will receive information on common responses of young children to cancer treatment and how parents can use music play activities to support their child during treatment. The music therapist will lead parent and child in a variety of music play activities. Parent and child will receive a music kit that includes items such as hand-held rhythm instruments, puppets, and a music CD. During the second and third visit the music therapist will lead parent and child child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home. |
| Arm II- Audio-Storybooks | Experimental | Behavioral: Audio StorybooksThree 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children ages 3-8 years inclusive.
- Expected treatment course for at least 3 days to receive chemotherapy and/or radiation therapy.
- A consistent parent who can be present for all sessions.
Key exclusion criteria (2 listed)
- Child and/or parent do not speak English.
- Child has a significant cognitive impairment that hinders participation (based on physician judgment).
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 |
|---|---|---|
| Active Music EngagementThree 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. During the first visit, parent and child will receive information on common responses of young children to cancer treatment and how parents can use music play activities to support their child during treatment. The music therapist will lead parent and child in a variety of music play activities. Parent and child will receive a music kit that includes items such as hand-held rhythm instruments, puppets, and a music CD. During the second and third visit the music therapist will lead parent and child child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home. | Behavioural | Arm 1-Active Music Engagement |
| Audio StorybooksThree 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration. | Behavioural | Arm II- Audio-Storybooks |
Primary outcome
Family Normalcy Perspective - Family Management Measure (FaMM)
Time frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
Family Normalcy is assessed through The Family Management Measure (FaMM) - Family Life Difficulty Subscale includes 14-items rated on a 5-point Likert-type scale. Subscale items address parents' perceptions of the extent to which having a child with a chronic condition makes family life difficult. Higher values indicate more difficulty managing the condition. Score range 14 - 70.
Parent Self-Efficacy - Parental Beliefs Scale (PBS).
Time frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
Parent Self-Efficacy is assessed through the Parental Beliefs Scale (PBS) for Hospitalized Children, a 20-item scale that measures parental beliefs about their confidence in anticipating changes in their hospitalized child's behavior and confidence in their parental role during hospitalization. Scores range from 20-100, with higher scores indicating more positive beliefs.
Child Emotional Distress - Child Health Questionnaire (CHQ)
Time frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
Child Emotional Distress is assessed through the Child Health Questionnaire (CHQ-PF98) Mental Health Subscale (Landgraf et al., 1999). This subscale consists of 16 items rated on a 5-point Likert-scale. Scores range from 16 to 80 with lower scores indicating better mental health.
Child Quality of Life - KINDL.
Time frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
Child Quality of Life is assessed through the KINDL Questionnaire for Measuring Health-Related Quality of Life in Children. The KINDL consists of 24 parent-report items rated on a 5-point Likert-scale for each subscale. Scores range from 20-100 with higher scores indicating better quality of life.
Parent Emotional and Traumatic Stress Symptoms - Profile of Mood States-Short Form (POMS).
Time frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
Parent Emotional and Traumatic Distress was assessed through the Profile of Mood States - Short Form (POMS-SF) which measures mood disturbance. There are 37 items which respondents rate on a 5-point Likert scale. Scores range from 0 to 148 with higher scores indicating greater mood disturbance.
Parent Emotional and Traumatic Stress Symptoms - Impact of Events Scale-Revised (IES-R)
Time frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
Stress Symptoms assessed through the Impact of Events Scale-Revised (IES-R), a 22-item measure that measures traumatic stress symptoms in response to a traumatic event that is specified in the instructions. Parents respond to each item using a 5-point Likert scale. Scores range from 0 to 12 with higher scores indicating greater traumatic stress symptoms.
Parent Quality of Life - Index of Well Being.
Time frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
Parent Quality of Life is assessed through the Index of Well-being, a 9-item semantic differential scale describing present life using adjective extremes. Scores range from 7 to 63 with higher scores meaning greater well-being.
Family Function - Family Adaptability and Cohesion Scale (FACES II).
Time frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
Family Function is assessed through the Family Adaptability and Cohesion Scale II (FACES II), a 30-item scale of items rated using a 5-point Likert scale. Scores range from 1 to 5, with higher scores meaning higher family adaptability and cohesion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18033724Robb SL, Clair AA, Watanabe M, Monahan PO, Azzouz F, Stouffer JW, Ebberts A, Darsie E, Whitmer C, Walker J, Nelson K, Hanson-Abromeit D, Lane D, Hannan A. A non-randomized [corrected] controlled trial of the active music engagement (AME) intervention on children with cancer. Psychooncology. 2008 Jul;17(7):699-708. doi: 10.1002/pon.1301.
- Background: PubMed 27289068Robb SL, Haase JE, Perkins SM, Haut PR, Henley AK, Knafl KA, Tong Y. Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer. J Pediatr Psychol. 2017 Mar 1;42(2):208-219. doi: 10.1093/jpepsy/jsw050.
- Background: PubMed 10932125Robb SL. The effect of therapeutic music interventions on the behavior of hospitalized children in isolation: developing a contextual support model of music therapy. J Music Ther. 2000 Summer;37(2):118-46. doi: 10.1093/jmt/37.2.118.
- Derived from this study: PubMed 38145309Robb SL, Stegenga K, Perkins SM, Stump TE, Moody KM, Henley AK, MacLean J, Jacob SA, Delgado D, Haut PR. Mediators and Moderators of Active Music Engagement to Reduce Traumatic Stress Symptoms and Improve Well-being in Parents of Young Children With Cancer. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231218266. doi: 10.1177/15347354231218266.
- Individual participant dataSharing planned: No
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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.
Sheri L Robb, PhD principal investigator
Indiana University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Music Engagement and Audio Storybooks in people with Cancer, run by Indiana University at 4 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 3 inclusion and 2 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 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Family Normalcy Perspective - Family Management Measure (FaMM) (time frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03085927, which also lists 4 linked publications.
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 11 Nov 2021.