This trial is active, not recruiting.

Condition parents who have lost a child to cancer
Treatment questionnaires/interviews
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator National Cancer Institute (NCI)
Start date August 2009
End date August 2017
Trial size 160 participants
Trial identifier NCT00968500, 09-107, NCT01324154


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
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.
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.

Primary Outcomes

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 Outcomes

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
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

Male or female participants at least 18 years old.

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.

Additional Information

Official title Understanding the Psychosocial Needs of Parents Who Have Lost a Child to Cancer
Principal investigator Wendy Lichtenthal, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.