NCT00968500

Brief Summary

The purpose of this study is to understand the experiences and needs of parents who have lost a child to cancer. This will aid us in developing an intervention that may help parents cope with their loss.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Aug 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Aug 2009Jun 2027

Study Start

First participant enrolled

August 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
17.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

17.8 years

First QC Date

August 28, 2009

Last Update Submit

April 16, 2026

Conditions

Keywords

Griefbereavementquestionnaires09-107

Outcome Measures

Primary Outcomes (1)

  • Identify the unique qualitative themes related to finding meaning among parents who lost a child to cancer to inform development of a conceptually sound meaning-centered grief intervention.

    2 years

Secondary Outcomes (2)

  • Determine differences in qualitative themes of meaning in parents in the high and low Prolonged Grief Disorder subgroups to help select a target population for a meaning-centered grief intervention.

    2 years

  • Explore and identify factors associated with bereaved parents' psychosocial service underutilization to guide the development of an acceptable and feasible meaning-centered grief intervention format.

    2 years

Study Arms (1)

Parents Who Have Lost a Child to Cancer

The overall goal of the proposed cross-sectional study is to obtain information necessary to the development of an effective Meaning-Centered Grief Intervention for parents who lost a child to cancer. In order to identify a subset of parents with whom we will conduct qualitative interviews with a subset of participants to address Aims 1 and 2, we will first screen participants to determine their levels of Prolonged Grief Disorder symptoms using a quantitative assessment (PG-13). The screening measure (PG-13) and the additional questionnaires included in the quantitative battery of measures will be analyzed to achieve Aim 3.

Behavioral: Questionnaires/Interviews

Interventions

Prior to the interview, the measure of prolonged grief disorder symptoms, the PG-13, will be re-administered to participants as a quality assurance check. We will administer 7 self-report measures, which participants can complete in our office, at home, or via telephone, depending on their preferences. These questionnaires should take approximately 75 to 80 minutes to complete. If you are asked to take part in the in-depth interview and you choose to take part, the interview that will take approximately 60 to 90 minutes to complete, depending on the length of the responses to the questions asked. The participant may also be asked if they would be willing to fill out an additional questionnaire about parents' thoughts on the most appropriate timing for raising the topic of a postmortem examination and factors that are important to include in discussions. Despite its importance, autopsy is often not discussed with parents whose child is dying from cancer.

Parents Who Have Lost a Child to Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Bereaved parents will be identified through death records kept by the Department of Pediatrics and cross-referenced with the deceased child's MSK medical record.

You may qualify if:

  • Loss of a child to cancer between 6 months and 6 years ago
  • Loss of a child between the ages of 6 months and 25 years
  • Biological or adoptive parent or stepparent
  • Parent must be age 18 or over
  • In the judgment of investigators/consenting professionals able to comprehend English to complete study assessments
  • To be eligible for the qualitative interview, participants more score of 19 or less (\< 19)or 34 or greater (\> 34) on the PG-13 to qualify

You may not qualify if:

  • Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude completion of the assessment measures, interview or informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NCI Clinical Center

Bethesda, Maryland, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Interventions

Surveys and QuestionnairesInterviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Rebecca Saracino, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

August 1, 2009

Primary Completion (Estimated)

June 2, 2027

Study Completion (Estimated)

June 2, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations