Understanding the Psychosocial Needs of Parents Who Have Lost a Child to Cancer

NCT ID: NCT00968500

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2027-06-02

Brief Summary

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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.

Detailed Description

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Conditions

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Parents Who Have Lost a Child to Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Questionnaires/Interviews

Intervention Type BEHAVIORAL

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.

Interventions

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Questionnaires/Interviews

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

University of Memphis

OTHER

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Nelson, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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NCI Clinical Center

Bethesda, Maryland, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan-Kettering Cancer Center

Other Identifiers

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09-107

Identifier Type: -

Identifier Source: org_study_id

NCT01324154

Identifier Type: -

Identifier Source: nct_alias

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