Malignant NeoplasmNCT01556256
Music Therapy Video Development in Improving Communication, Emotional Distress, and Recovery in Adolescents/Young Adults Undergoing Treatment for High-Risk Cancer and Their Parents
A study testing Caregiver-Related Intervention or Procedure, Music Therapy and Quality-of-Life Assessment in people with Malignant Neoplasm, run by Children's Oncology Group at 8 sites in United States.
Trial summary
This randomized trial studies how well music therapy and parents' education work in improving communication, emotional distress, and recovery in adolescents/young adult patients undergoing treatment for high-risk cancer and their parents. 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?
- Caregiver-Related Intervention or Procedure, Music Therapy 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
- 124 participants
- Where
- 8 sitesUnited States
- Study dates
- 23 Apr 2012to 2 Oct 2023
- Phase
- Interventional
- 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
- AYA has initial or relapsed cancer diagnosis and is actively on treatment and will continue to be on treatment long enough to complete the intervention and evaluation (4 to 6 weeks)
- AYA meets at least 1 of 3 criteria indicating potentially high palliative care or end-of-life needs:
- Any high-risk cancer (i.e., metastatic or stage IV)
- Receiving moderate- to high-intensity chemotherapy during 3-5 consecutive days in an in- or out-patient setting
- A diagnosis with an estimated 5-year event-free survival of < 50%
- AYA is able to participate in sessions as evaluated by the Karnofsky/Lansky score of 50% or greater
Show all 9Show fewer
- One consistent parent is willing and available to participate in all parent and evaluation sessions
- AYA is not married and has no children
- AYA and parent are able to read, understand, and speak English
Who cannot join
- Cancers not usually occurring in childhood/adolescent or young adult populations, such as lung or prostate cancer
- Cognitive impairments that would make it difficult for AYA/parents to participate in the intervention or complete questionnaires (determination in consultation with attending physician, oncologist, and, for adolescents below age 18, the parents)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, 30342
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Cook Children's Medical Center
Fort Worth, Texas, 76104
Riley Hospital for Children
Indianapolis, Indiana, 46202
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Music Video for AYA-Parent Communication and Resilience
This randomized trial studies how well music therapy and parents' education work in improving communication, emotional distress, and recovery in adolescents/young adult patients undergoing treatment for high-risk cancer and their parents. Making a music therapy video may improve communication, emotional distress, and recovery in younger patients undergoing treatment for cancer. It is not yet known whether music therapy and counseling for parents is more effective than information handouts for parents in improving communication and emotional distress in patients undergoing treatment for cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Compare the efficacy of a Therapeutic Music Video (TMV) intervention with a Therapeutic Music Video plus Parent (TMV+P) intervention on outcomes for adolescents/young adults (AYA) undergoing treatment for high-risk cancer.
II. Compare the efficacy of a TMV intervention with a TMV+P intervention on outcomes for parents of AYA with high-risk cancer.
III. Determine relationships of parent distress and parent perceived family environment with AYA outcomes using a mixed methods approach. (exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to age in years (11-13 vs 14-17 vs 18-24). Parents are randomized to 1 of 2 intervention arms.
ARM I (TMV, low-dose parent): AYA patients undergo 60-minute sessions, delivered in a private setting during outpatient clinic visits or hospitalizations, within a 6-8 weeks period with board-certified music therapists. The music therapists help patients in brainstorming and lyric writing, singing and creatively exploring how AYA lyrics and structure of the selected music fit together, recording their song with a digital accompaniment track, completing video layout worksheets (determining the contents of the video), taking and gathering photos or making drawings for the video, and viewing clip art and pictures on a computer. The music therapist then digitally formats, compiles, and transfers the AYA-developed music video to a DVD. When completed, the therapist shares the video with the AYA and offers the option of having a video "premiere." AYAs who choose a premiere select a date and time for the viewing and identify individuals they wish to attend (family, friends, healthcare professionals). After the viewing, AYAs receive a copy of their DVD to keep. Parents' presence and involvement during all sessions are directed by the AYAs. Parents receive 2 sessions over 15-60 minutes with a trained study team. During the first session, parents receive handouts of helpful website resources that have specific information to help parents support their AYAs. Team members also assure that parents know how to assess the sites. During the second session, parents receive audio-recorded, telephone-based contact by a trained nurse who asks them questions focusing on the content available on the provided website. The trained nurse also answers any questions parents may have.
ARM II (AYA TMV +P): AYA patients receive intervention as patients in arm I. Parents receive 3 tailored 60-minute sessions with a trained nurse intervener. Sessions are recorded to make sure study nurse delivers the sessions according to the study protocol. Study nurse provides support information to parents using the Robb's Contextual Support Model, including Managing the Chaos: Self Care as the First Step to Caring for Your AYA, Relationship Support: How to Listen to and Encourage Your AYA to Talk; and Strategies for AYA Autonomy Support: Understanding AYA's Ways of Coping. Session 3 content is also based on the Resilience in Illness model. Sessions are also tailored to parents' needs, skills practice and/or role playing, and reflection on and reinforcement of learning. Parents receive written materials on tips and prescribed skills practice plans. AYA and parents complete questionnaires including Illness-Related Distress, Defensive Coping, Spiritual Perspective, Social Integration, Family Environment questionnaires, Hope-Derived Meaning, Self-Transcendence, Positive Coping, Resilience, Parent Distress, and Quality of Life at baseline, at 2 weeks after final session, and then at 90 days after final intervention session. Medical background, intensity of treatment rating scale, and family demographics are also collected.
- Conditions
- Malignant Neoplasm
- Being tested
- Caregiver-Related Intervention or Procedure, Music Therapy, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver-Related Intervention or ProcedureOther
Undergo TMV+P
Music TherapyProcedure or surgery
Undergo TMV
Music TherapyProcedure or surgery
Undergo TMV+P
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (TMV) | Experimental | See detailed description. Receives: Procedure: Music Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (TMV+P) | Experimental | See detailed description. Receives: Other: Caregiver-Related Intervention or Procedure; Procedure: Music Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
AYA illness-related distress measured by the Mishel Uncertainty in Illness Scale and the McCorkle Symptom Distress scale
The MPLUS software will be used to perform latent variable analysis of covariance (ANCOVA) to account for measurement error and to reduce the number of comparisons.
Measured: Up to 90 days
AYA defensive coping measured by the Jalowiec Coping Scale-Revised
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Measured: Up to 90 days
AYA spiritual perspective measured by the Reed Spiritual Perspective Scale
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Measured: Up to 90 days
AYA social integration measured by the Perceived Social Support-Family scale, the Perceived Social Support-Friends scale, and the Perceived Social Support-Health Care Providers
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Measured: Up to 90 days
AYA family environment measured by the Family Adaptability and Cohesion Scale II
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Measured: Up to 90 days
AYA family environment measured by the Parent-Adolescent Communication scale
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Measured: Up to 90 days
AYA family environment measured by the Family Strengths Scale
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Measured: Up to 90 days
AYA positive coping measured by the Jalowiec Coping Scale-Revised
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Measured: Up to 90 days
AYA hope-derived meaning measured by the Herth Hope Index
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Measured: Up to 90 days
AYA self-transcendence measured by the Reed Self-Transcendence scale
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Measured: Up to 90 days
AYA resilience measured by the Nowotny Confidence subscale, the Haase Resilience in Illness Scale, and the Index of Well-Being
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Measured: Up to 90 days
Parental distress measured by the Perceived Stress Scale, the Profile of Mood States-Short Form, and the Spielberger's State-Trait Anxiety Inventory-State Component
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Measured: Up to 90 days
Parent family environment measured by the Family Adaptability and Cohesion Scale
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Measured: Up to 90 days
Parent family environment measured by the Parent-Adolescent Communication scale
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Measured: Up to 90 days
Parent family environment measured by the Family Strengths Scale
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Measured: Up to 90 days
Parent family environment measured by the Perceived Social Support-Health Care Providers
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Measured: Up to 90 days
Parent quality of life measured by the Index of Well-being
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study start23 Apr 2012
- Primary completion31 Aug 2016
- Study completion2 Oct 2023
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joan E Haase, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556256
- Sponsor's protocol ID
- ANUR1131
- Other IDs
- NCI-2012-00682, CDR0000726664, COG-ANUR1131, ANUR1131, COG-ANUR1131, ANUR1131, R01CA162181, U10CA095861
- Status last verified
- Oct 2023
- First submitted
- 15 Mar 2012
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Video for AYA-Parent Communication and Resilience
- ClinicalTrials.gov ID
- NCT01556256
- Acronym / sponsor ID
- ANUR1131
- Conditions
- Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Apr 2012 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 16 Mar 2012 (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 trial studies how well music therapy and parents' education work in improving communication, emotional distress, and recovery in adolescents/young adult patients undergoing treatment for high-risk cancer and their parents. Making a music therapy video may improve communication, emotional distress, and recovery in younger patients undergoing treatment for cancer. It is not yet known whether music therapy and counseling for parents is more effective than information handouts for parents in improving communication and emotional distress in patients undergoing treatment for cancer.
Detailed description
PRIMARY OBJECTIVES:
- Compare the efficacy of a Therapeutic Music Video (TMV) intervention with a Therapeutic Music Video plus Parent (TMV+P) intervention on outcomes for adolescents/young adults (AYA) undergoing treatment for high-risk cancer.
II. Compare the efficacy of a TMV intervention with a TMV+P intervention on outcomes for parents of AYA with high-risk cancer.
III. Determine relationships of parent distress and parent perceived family environment with AYA outcomes using a mixed methods approach. (exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to age in years (11-13 vs 14-17 vs 18-24). Parents are randomized to 1 of 2 intervention arms.
ARM I (TMV, low-dose parent): AYA patients undergo 60-minute sessions, delivered in a private setting during outpatient clinic visits or hospitalizations, within a 6-8 weeks period with board-certified music therapists. The music therapists help patients in brainstorming and lyric writing, singing and creatively exploring how AYA lyrics and structure of the selected music fit together, recording their song with a digital accompaniment track, completing video layout worksheets (determining the contents of the video), taking and gathering photos or making drawings for the video, and viewing clip art and pictures on a computer. The music therapist then digitally formats, compiles, and transfers the AYA-developed music video to a DVD. When completed, the therapist shares the video with the AYA and offers the option of having a video "premiere." AYAs who choose a premiere select a date and time for the viewing and identify individuals they wish to attend (family, friends, healthcare professionals). After the viewing, AYAs receive a copy of their DVD to keep. Parents' presence and involvement during all sessions are directed by the AYAs. Parents receive 2 sessions over 15-60 minutes with a trained study team. During the first session, parents receive handouts of helpful website resources that have specific information to help parents support their AYAs. Team members also assure that parents know how to assess the sites. During the second session, parents receive audio-recorded, telephone-based contact by a trained nurse who asks them questions focusing on the content available on the provided website. The trained nurse also answers any questions parents may have.
ARM II (AYA TMV +P): AYA patients receive intervention as patients in arm I. Parents receive 3 tailored 60-minute sessions with a trained nurse intervener. Sessions are recorded to make sure study nurse delivers the sessions according to the study protocol. Study nurse provides support information to parents using the Robb's Contextual Support Model, including Managing the Chaos: Self Care as the First Step to Caring for Your AYA, Relationship Support: How to Listen to and Encourage Your AYA to Talk; and Strategies for AYA Autonomy Support: Understanding AYA's Ways of Coping. Session 3 content is also based on the Resilience in Illness model. Sessions are also tailored to parents' needs, skills practice and/or role playing, and reflection on and reinforcement of learning. Parents receive written materials on tips and prescribed skills practice plans. AYA and parents complete questionnaires including Illness-Related Distress, Defensive Coping, Spiritual Perspective, Social Integration, Family Environment questionnaires, Hope-Derived Meaning, Self-Transcendence, Positive Coping, Resilience, Parent Distress, and Quality of Life at baseline, at 2 weeks after final session, and then at 90 days after final intervention session. Medical background, intensity of treatment rating scale, and family demographics are also collected.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (TMV) | Experimental | Procedure: Music Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationSee detailed description. |
| Arm II (TMV+P) | Experimental | Other: Caregiver-Related Intervention or Procedure, Procedure: Music Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationSee detailed description. |
Who may qualify
- Ages
- 11 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- AYA has initial or relapsed cancer diagnosis and is actively on treatment and will continue to be on treatment long enough to complete the intervention and evaluation (4 to 6 weeks)
- AYA meets at least 1 of 3 criteria indicating potentially high palliative care or end-of-life needs:
- AYA is able to participate in sessions as evaluated by the Karnofsky/Lansky score of 50% or greater
- One consistent parent is willing and available to participate in all parent and evaluation sessions
- AYA is not married and has no children
Key exclusion criteria (2 listed)
- Cancers not usually occurring in childhood/adolescent or young adult populations, such as lung or prostate cancer
- Cognitive impairments that would make it difficult for AYA/parents to participate in the intervention or complete questionnaires (determination in consultation with attending physician, oncologist, and, for adolescents below age 18, the parents)
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 |
|---|---|---|
| Caregiver-Related Intervention or ProcedureUndergo TMV+P | Other | Arm II (TMV+P) |
| Music TherapyUndergo TMV | Procedure or surgery | Arm I (TMV) |
| Music TherapyUndergo TMV+P | Procedure or surgery | Arm II (TMV+P) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (TMV), Arm II (TMV+P) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (TMV), Arm II (TMV+P) |
Primary outcome
AYA illness-related distress measured by the Mishel Uncertainty in Illness Scale and the McCorkle Symptom Distress scale
Time frame: Up to 90 days
The MPLUS software will be used to perform latent variable analysis of covariance (ANCOVA) to account for measurement error and to reduce the number of comparisons.
AYA defensive coping measured by the Jalowiec Coping Scale-Revised
Time frame: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA spiritual perspective measured by the Reed Spiritual Perspective Scale
Time frame: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA social integration measured by the Perceived Social Support-Family scale, the Perceived Social Support-Friends scale, and the Perceived Social Support-Health Care Providers
Time frame: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA family environment measured by the Family Adaptability and Cohesion Scale II
Time frame: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA family environment measured by the Parent-Adolescent Communication scale
Time frame: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA family environment measured by the Family Strengths Scale
Time frame: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA positive coping measured by the Jalowiec Coping Scale-Revised
Time frame: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA hope-derived meaning measured by the Herth Hope Index
Time frame: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA self-transcendence measured by the Reed Self-Transcendence scale
Time frame: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA resilience measured by the Nowotny Confidence subscale, the Haase Resilience in Illness Scale, and the Index of Well-Being
Time frame: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Parental distress measured by the Perceived Stress Scale, the Profile of Mood States-Short Form, and the Spielberger's State-Trait Anxiety Inventory-State Component
Time frame: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Parent family environment measured by the Family Adaptability and Cohesion Scale
Time frame: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Parent family environment measured by the Parent-Adolescent Communication scale
Time frame: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Parent family environment measured by the Family Strengths Scale
Time frame: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Parent family environment measured by the Perceived Social Support-Health Care Providers
Time frame: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Parent quality of life measured by the Index of Well-being
Time frame: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
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 10 Oct 2023.
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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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver-Related Intervention or Procedure, Music Therapy and Quality-of-Life Assessment in people with Malignant Neoplasm, run by Children's Oncology Group at 8 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 9 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
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?
AYA illness-related distress measured by the Mishel Uncertainty in Illness Scale and the McCorkle Symptom Distress scale (time frame: Up to 90 days). The study lists 17 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 10 Oct 2023.