Adolescent Oncology PatientsALOSSNCT01473862
Adolescent Loss: The Impact of Loss on Adolescent Oncology Patients
An observational study of Adolescent Oncology Patients, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Teen loss is not uncommon. Depression, emptiness, disbelief, hopelessness, and guilt are typical responses. How teens with cancer cope with the loss of a loved one or a close friend has not been well-studied in the bereavement or oncology literature. Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Adolescent Oncology Patients
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2016
- Phase
- Observational
- 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 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: English-speaking adolescent oncology patients (age 13-21) at St. Jude Children's Research Hospital who have been on therapy for ≥ 12 months (≥ 6 months if progressive or refractory disease) OR off therapy for ≤ 3 years.
Who may be able to join
- Age 13-21 inclusive at time of study enrollment
- English speaking
- Research participant carries a diagnosis of a malignancy (or serious non-malignant disorder requiring HSCT) >12 months.
- Research participant carries a diagnosis of a malignancy (or serious non-malignant disorder requiring HSCT) for >6 months and <12 months but has evidence of refractory/progressive disease.
- Patients who have completed cancer-directed therapy >36 months ago are not eligible. (Note: Allogenic transplant recipients will be considered "off-therapy" 1 year after HSCT.)
- No known history of significant cognitive deficits (i.e. with major impairments) that would preclude completion of study measures; not meant to exclude research participants with mild learning problems.
- Research participant and 1 parent willing to participate and provide consent/assent according to institutional guidelines. Parent may decline to participate in parental inventories, but consent to adolescent participation.
Who cannot join
- Less than 13-years of age at completion of therapy.
- Patients on hospice who are without scheduled follow-up at St. Jude Children's Research Hospital (SJCRH)
- "Observation" patients. Patients that are being followed by imaging due to previous identification of an atypical lesion on radiographic imaging not identified to have a specific diagnosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Teen loss is not uncommon. Depression, emptiness, disbelief, hopelessness, and guilt are typical responses. How teens with cancer cope with the loss of a loved one or a close friend has not been well-studied in the bereavement or oncology literature. This study will describe the impact of loss on teen patients who are on treatment or have recently completed treatment for malignancy. We will look at baseline personality traits and ask teens to identify losses in their life. We will ask questions about coping and meaning-making after loss. A parent will be invited to participate -to measure parental awareness of teen loss and determine if parental coping affects teen coping. The inventories have been validated by other researchers.
Read the detailed description
All participants will asked to complete a bereavement questionnaire quantifying the losses they have experienced. All participants will be screened for depression/anxiety as well as life outlook using validated tools. Patients who identify that they have experienced the loss of someone significant in their life on the bereavement questionnaire will continue with the study and complete a battery of validated psychological inventories. They will be asked to identify their most significant loss in regards to completion of the remainder of the questionnaire. In addition, those who identify losing a friend to cancer will be invited to participate in a 30-45 minute semi-structured interview (in person or via telephone) during a second session with the study staff. This interview will be audiotaped, to allow for transcription and analysis later. Parents will complete demographic information, the bereavement questionnaire, and complete inventories of family coping / cohesion regardless of child's responses to bereavement questionnaire.
In addition, those who identify losing a friend to cancer will be invited to participate in a 30-45 minute semi-structured interview (in person or via telephone) during a second session with the study staff.
Primary Objectives:
- Estimate the prevalence of loss, with particular interest in the extent of peer loss, in adolescent oncology patients who have been on therapy ≥ 12 months (≥ 6 months if progressive or refractory disease) or off therapy for ≤ 3 years.
- Describe the impact of loss on adolescent oncology patients by focusing on coping efficacy, psychological distress, meaning-making, and complicated bereavement.
Secondary Objective:
- Describe parental knowledge of losses experienced by an adolescent child who has recently undergone therapy.
- Conditions
- Adolescent Oncology Patients
- Keywords
- adolescent, bereavement, cancer, coping skills
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who have experienced the death of a friend or relative by type of loss.
The prevalence of loss among the participants will be calculated. The type of losses will be described.
Measured: Once on Day 1
Descriptive statistics of coping efficacy scores, psychological distress scores, meaning-making scores, and complicated bereavement scores.
All data for this objective will be mainly analyzed in a descriptive manner. The score for coping efficacy will be calculated from the General Coping Efficacy instrument. In addition, a subset of participants who identify losing a friend to cancer will be invited to complete a 30-45 minute semi-structured interview.
Measured: Once on Day 1
Secondary outcomes (1)
Number of parents with knowledge of losses experienced by adolescent child.
Descriptive analysis from the Bereavement Questionnaire (parent version).
Measured: Once on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Oncology PatientsStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liza Johnson, MD,MPH, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473862
- Sponsor's protocol ID
- XPD11-150 ALOSS
- Acronym
- ALOSS
- Status last verified
- Aug 2016
- First submitted
- 8 Nov 2011
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Loss: The Impact of Loss on Adolescent Oncology Patients
- ClinicalTrials.gov ID
- NCT01473862
- Acronym / sponsor ID
- ALOSS / XPD11-150 ALOSS
- Conditions
- Adolescent Oncology Patients
- Keywords
- adolescent, bereavement, cancer, coping skills
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Nov 2011 (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.
Teen loss is not uncommon. Depression, emptiness, disbelief, hopelessness, and guilt are typical responses. How teens with cancer cope with the loss of a loved one or a close friend has not been well-studied in the bereavement or oncology literature. This study will describe the impact of loss on teen patients who are on treatment or have recently completed treatment for malignancy. We will look at baseline personality traits and ask teens to identify losses in their life. We will ask questions about coping and meaning-making after loss. A parent will be invited to participate -to measure parental awareness of teen loss and determine if parental coping affects teen coping. The inventories have been validated by other researchers.
Detailed description
All participants will asked to complete a bereavement questionnaire quantifying the losses they have experienced. All participants will be screened for depression/anxiety as well as life outlook using validated tools. Patients who identify that they have experienced the loss of someone significant in their life on the bereavement questionnaire will continue with the study and complete a battery of validated psychological inventories. They will be asked to identify their most significant loss in regards to completion of the remainder of the questionnaire. In addition, those who identify losing a friend to cancer will be invited to participate in a 30-45 minute semi-structured interview (in person or via telephone) during a second session with the study staff. This interview will be audiotaped, to allow for transcription and analysis later. Parents will complete demographic information, the bereavement questionnaire, and complete inventories of family coping / cohesion regardless of child's responses to bereavement questionnaire.
In addition, those who identify losing a friend to cancer will be invited to participate in a 30-45 minute semi-structured interview (in person or via telephone) during a second session with the study staff.
Primary Objectives:
- Estimate the prevalence of loss, with particular interest in the extent of peer loss, in adolescent oncology patients who have been on therapy ≥ 12 months (≥ 6 months if progressive or refractory disease) or off therapy for ≤ 3 years.
- Describe the impact of loss on adolescent oncology patients by focusing on coping efficacy, psychological distress, meaning-making, and complicated bereavement.
Secondary Objective:
- Describe parental knowledge of losses experienced by an adolescent child who has recently undergone therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- English-speaking adolescent oncology patients (age 13-21) at St. Jude Children's Research Hospital who have been on therapy for ≥ 12 months (≥ 6 months if progressive or refractory disease) OR off therapy for ≤ 3 years.
Key inclusion criteria (7 listed)
- Age 13-21 inclusive at time of study enrollment
- English speaking
- Research participant carries a diagnosis of a malignancy (or serious non-malignant disorder requiring HSCT) >12 months.
- Research participant carries a diagnosis of a malignancy (or serious non-malignant disorder requiring HSCT) for >6 months and <12 months but has evidence of refractory/progressive disease.
- Patients who have completed cancer-directed therapy >36 months ago are not eligible. (Note: Allogenic transplant recipients will be considered "off-therapy" 1 year after HSCT.)
Key exclusion criteria (3 listed)
- Less than 13-years of age at completion of therapy.
- Patients on hospice who are without scheduled follow-up at St. Jude Children's Research Hospital (SJCRH)
- "Observation" patients. Patients that are being followed by imaging due to previous identification of an atypical lesion on radiographic imaging not identified to have a specific diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants who have experienced the death of a friend or relative by type of loss.
Time frame: Once on Day 1
The prevalence of loss among the participants will be calculated. The type of losses will be described.
Descriptive statistics of coping efficacy scores, psychological distress scores, meaning-making scores, and complicated bereavement scores.
Time frame: Once on Day 1
All data for this objective will be mainly analyzed in a descriptive manner. The score for coping efficacy will be calculated from the General Coping Efficacy instrument. In addition, a subset of participants who identify losing a friend to cancer will be invited to complete a 30-45 minute semi-structured interview.
1 secondary outcome
Number of parents with knowledge of losses experienced by adolescent child.
Time frame: Once on Day 1
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 12 Aug 2016.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
Liza Johnson, MD,MPH principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Oncology Patients, run by St. Jude Children's Research Hospital at 1 site 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 7 inclusion and 3 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 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of participants who have experienced the death of a friend or relative by type of loss. (time frame: Once on Day 1). The study lists 2 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 12 Aug 2016.