Adolescent Loss: The Impact of Loss on Adolescent Oncology Patients (ALOSS)

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.

Study Overview

• Status: Completed
• Conditions: Adolescent Oncology Patients

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 Type: Observational
• Enrollment (Actual): 153

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of parents with knowledge of losses experienced by adolescent child.	Descriptive analysis from the Bereavement Questionnaire (parent version).	Once on Day 1

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Liza Johnson, MD,MPH, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 8, 2011
• First Submitted That Met QC Criteria: November 14, 2011
• First Posted (Estimate): November 17, 2011

Study Record Updates

• Last Update Posted (Estimate): August 12, 2016
• Last Update Submitted That Met QC Criteria: August 11, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: cancer; adolescent; coping skills; bereavement
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: XPD11-150 ALOSS