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Evaluation of Grief Therapy Approaches for Bereaved Parents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05142605
Recruitment Status : Recruiting
First Posted : December 2, 2021
Last Update Posted : January 17, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to compare three types of support programs for parents who have lost a child. The study will see how these support programs affect participants' grief and depression symptoms. The three support programs are called meaning-centered grief therapy, supportive counseling, and enhanced usual care

Condition or disease Intervention/treatment
Parents Bereavement Grief Behavioral: Meaning-Centered Grief Therapy Behavioral: Supportive Psychotherapy Behavioral: Enhanced usual care

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Study Type : Observational
Estimated Enrollment : 265 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Meaning-Centered Grief Therapy for Parents Bereaved by Cancer: A Multisite Randomized Controlled Trial
Actual Study Start Date : December 28, 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bereavement

Group/Cohort Intervention/treatment
Cohort 1: Meaning-Centered Grief Therapy/MCGT
Participants will consist of parents who have lost a child to a cancer diagnosis within the last 6 months
Behavioral: Meaning-Centered Grief Therapy
Meaning-centered grief therapy is therapy that focuses on helping participants find a sense of meaning or purpose in their life after their loss. This support program will involve 16 sessions that will take place about once a week, and each session will last 60 to 90 minutes.
Other Name: MCGT

Group 2: Supportive Psychotherapy /SP
Participants will consist of parents who have lost a child to a cancer diagnosis within the last 6 months
Behavioral: Supportive Psychotherapy
Supportive psychotherapy will help participants cope with their loss by giving them a place to express their feelings and providing them with support during the sessions. Supportive counseling will involve 16 sessions that will take place about once a week, and each session will last 60 to 90 minutes.
Other Name: SP

Group 3: Enhanced usual care/EUC
Participants will consist of parents who have lost a child to a cancer diagnosis within the last 6 months
Behavioral: Enhanced usual care
Enhanced usual care includes any support or resources participants may receive as part of their standard care (for example, therapy sessions with a local therapist), enhanced with additional resources
Other Name: EUC




Primary Outcome Measures :
  1. Elevated prolonged grief (PG) symptoms [ Time Frame: 6 months ]
    PG-13-R scores of 30 or above (N/A for training case participants)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This RCT will enroll 265 participants from MSK (n=143), St. Jude (n=66), and CHOP (n=56). Similar procedures will be followed at each of the data collection sites. We will also receive referrals from community organizations.
Criteria

Inclusion Criteria:

  • A biological, adoptive, or step-parent from across the United States who lost a child diagnosed with cancer
  • Age 18 or older
  • Experienced the loss of a child to cancer at least 6 months prior to enrollment
  • Elevated prolonged grief (PG) symptoms (PG-13-R scores of 30 or above) (N/A for training case participants)
  • Resides in a state in which a study clinical supervisor is licensed to permit telepsychology practice or otherwise able to comply with current telehealth regulations
  • English-speaking as per the language assessment items below and willing to receive the intervention in English.
  • What is the participant's preferred language?

    °(Specify Lang)___________________________

  • How well does the participant speak English?

    • Very well (PARTICIPANT IS ELIGIBLE)
    • Well (PARTICIPANT is NOT ELIGIBLE)
    • Not well (PARTICIPANT is NOT ELIGIBLE)
    • Not at all (PARTICIPANT is NOT ELIGIBLE)

Support Provider Inclusion Criteria:

  • Must be age 18 or over as indicated by self-report
  • Has been identified by the bereaved parent participant as a support or someone important to bereaved parent
  • Resides in a state in which a study clinical supervisor is licensed to permit telepsychology practice or otherwise able to comply with current telehealth regulations

Exclusion Criteria:

  • Inability to access a functional device for videoconferencing and declines offer to use a study loaner device.

Support Provider Exclusion Criteria:

  • Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude completion of the informed consent
  • Inability to access a computer with Internet or inability to use a computer with Internet provided by the study as indicated by self-report

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): NCT05142605


Contacts
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Contact: Wendy Lichtenthal, PhD 646-608-8204 lichtenw@mskcc.org
Contact: William Breitbart, MD 646-888-0020 breitbaw@MSKCC.ORG

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Wendy Lichtenthal, PhD    646-888-4812      
Principal Investigator: Wendy Lichtenthal, PhD         
United States, Pennsylvania
Children's Hospital of Philadelphia (Data Collection Only) Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lamia Barakat, PhD    267-426-0762      
United States, Tennessee
St Jude's Children's Hospital (Data collection only) Not yet recruiting
Memphis, Tennessee, United States, 38105
Contact: Justin Baker, MD    901-725-1785      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Wendy Lichtenthal, PhD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT05142605    
Other Study ID Numbers: 21-462
First Posted: December 2, 2021    Key Record Dates
Last Update Posted: January 17, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Parental bereavement
parents
Elevated prolonged grief symptoms
Memorial Sloan Kettering Cancer Center
21-462