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

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ClinicalTrials.gov Identifier: NCT00968500
Recruitment Status : Active, not recruiting
First Posted : August 31, 2009
Last Update Posted : July 6, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Parents Who Have Lost a Child to Cancer Behavioral: Questionnaires/Interviews

Study Design

Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Understanding the Psychosocial Needs of Parents Who Have Lost a Child to Cancer
Study Start Date : August 2009
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bereavement
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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

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.

Outcome Measures

Primary Outcome Measures :
  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. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 2 years ]
  2. 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. [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968500

United States, Maryland
NCI Clinical Center
Bethesda, Maryland, United States
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Ohio State University
University of Memphis
University of Southern California
Principal Investigator: Wendy Lichtenthal, PhD Memorial Sloan Kettering Cancer Center
More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00968500     History of Changes
Obsolete Identifiers: NCT01324154
Other Study ID Numbers: 09-107
First Posted: August 31, 2009    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017

Keywords provided by Memorial Sloan Kettering Cancer Center: