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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by St. Jude Children's Research Hospital
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01473862
First received: November 8, 2011
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition
Adolescent Oncology Patients

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Adolescent Loss: The Impact of Loss on Adolescent Oncology Patients

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Number of participants who have experienced the death of a friend or relative by type of loss. [ Time Frame: Once on Day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of parents with knowledge of losses experienced by adolescent child. [ Time Frame: Once on Day 1 ] [ Designated as safety issue: No ]
    Descriptive analysis from the Bereavement Questionnaire (parent version).


Estimated Enrollment: 175
Study Start Date: January 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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.

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.
  Eligibility

Ages Eligible for Study:   13 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473862

Contacts
Contact: Liza Johnson, MD,MPH 866-278-5833 info@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Liza Johnson, MD,MPH         
Principal Investigator: Liza Johnson, MD,MPH         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Liza Johnson, MD,MPH St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01473862     History of Changes
Other Study ID Numbers: XPD11-150 ALOSS
Study First Received: November 8, 2011
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
adolescent
bereavement
cancer
coping skills

ClinicalTrials.gov processed this record on July 23, 2014