Adolescent Oncology Patients Clinical Trial
— ALOSSOfficial title:
Adolescent Loss: The Impact of Loss on Adolescent Oncology Patients
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.
| Status | Completed |
| Enrollment | 153 |
| Est. completion date | June 2016 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 13 Years to 21 Years |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| St. Jude Children's Research Hospital |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Once on Day 1 | No |
| Primary | 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. | Once on Day 1 | No |
| Secondary | Number of parents with knowledge of losses experienced by adolescent child. | Descriptive analysis from the Bereavement Questionnaire (parent version). | Once on Day 1 | No |