Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Development of Psychotherapeutic Interventions for Parents Who Lost a Child to Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Memorial Sloan Kettering Cancer Center
Sponsor:
Collaborators:
University of Memphis
University of Hawaii
Adelphi University
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02153619
First received: May 22, 2014
Last updated: August 22, 2016
Last verified: August 2016
  Purpose
Many parents who have lost a child use counseling or other resources to help with the emotional burden of their loss. The aim of this study is to begin to test a new counseling program for parents who have lost a child to cancer.

Condition Intervention
Parents Who Have Lost a Child to Cancer
Behavioral: Meaning-Centered Grief Therapy (MCGT)
Behavioral: Supportive Psychotherapy (SP)
Behavioral: questionnaires assessments

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Development of Psychotherapeutic Interventions for Parents Who Lost a Child to Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • feasibility defined and measured as the proportion of participants who complete at least 8 out of 16 sessions of therapy as well as completion of the T3 PG-13 assessment [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • psychological outcome data in prolonged grief symptoms, assessed with the PG-13 summary score. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: May 2014
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meaning-Centered Grief Therapy (MCGT)
Part 1: Open Trials. Participants (n = 5 for Step 1 & n = 5 for Step 2) will receive 16 1-hour (approx) weekly sessions MCGT, & all therapy sessions will be audio recorded. Will make every effort to complete 16 sessions in 16 weeks, due to normal life activities, this is considered an approximation (i.e. there may be weeks where sessions don't take place &/or weeks where more than 1 session takes place in a week). If participant provides us with permission, we will also video record the sessions. Assessments will be administered at 4 time points: pre-intervention (T1), mid-intervention (T2), post-intervention (T3), & at 3-months post-intervention (T4). They will provide their feedback about MCGT & the measures. PI will review the open trial sessions to help refine the MCGT manual & treatment integrity forms. Sessions for Step 1 participants in Part 1 will be held at the MSK Counseling Center. Sessions for Step 2 participants in Part 1 will be conducted via videoconferencing.
Behavioral: Meaning-Centered Grief Therapy (MCGT)
MCGT is a manualized, one-on-one intervention that uses psychoeducation, experiential exercises, and homework focusing on themes related to meaning, identity, purpose, and legacy. Post-intervention qualitative exit interviews will assess acceptability of the MCGT intervention (see Appendix I). Participants randomized to MCGT will provide their feedback about MCGT and the measures (n = 33).
Behavioral: questionnaires assessments
Experimental: MCGT or Supportive Psychotherapy
Part 2: Pilot RCT. Will randomize 66 parents to 16 weekly 1-hour (approx) sessions of MCGT or SP delivered via videoconferencing. Again, sessions will be audio recorded. If the participant provides us with permission, we also video record the sessions. We will examine aspects of study implementation & therapy process, including a) recruitment progress, b) implementation of the intervention, c) administration of the assessments, & d) retention. We will also examine acceptability, defined as measures of satisfaction at T3. Psychosocial outcomes will be assessed with self-report measures at 4 time points: pre-intervention (T1), mid-intervention (T2), post-intervention (T3), & at 3-months post-intervention (T4). Post-intervention qualitative exit interviews will assess acceptability of the intervention. Post-intervention qualitative exit interviews will assess acceptability of the MCGT intervention .
Behavioral: Meaning-Centered Grief Therapy (MCGT)
MCGT is a manualized, one-on-one intervention that uses psychoeducation, experiential exercises, and homework focusing on themes related to meaning, identity, purpose, and legacy. Post-intervention qualitative exit interviews will assess acceptability of the MCGT intervention (see Appendix I). Participants randomized to MCGT will provide their feedback about MCGT and the measures (n = 33).
Behavioral: Supportive Psychotherapy (SP)
"SP is the comparison condition in this study and is a standardized, manualized intervention developed by the MSKCC Psychiatry Service and utilized in our completed and ongoing RCTs of Meaning-Centered Psychotherapy."
Behavioral: questionnaires assessments

Detailed Description:

There are two parts to this study. Adapting and refining the MCGT intervention manual will be accomplished primarily in Part 1, building upon a preparatory project to obtain feedback on the MCGT intervention manual and materials.

Step 1 of Part 1 will involve a brief open trial of MCGT delivered in person at an MSKCC location with individual parents (n=5) to further refine the treatment through active participant feedback and identify ways to improve therapeutic alliance to maximize the impact of delivery via videoconferencing. Parents may also invite a support provider to join them for Session 9 (support provider n = 5). Support providers will not be evaluated as research participants.

Step 2 of Part 1 will be another brief open trial (n=5) delivering MCGT via video conferencing in order to iron out any logistical challenges prior to the pilot randomized controlled trial (RCT). The investigators hope to use videoconferencing in order to ultimately improve parents' access to supportive services. Participants will be able to complete sessions wherever they have both privacy and access to a computer and the internet. Parents may also invite a support provider to join them for Session 9 (support provider n = 5). Support providers will not be evaluated as research participants.

All Part 1 participants will be assessed pre-intervention (T1), mid-intervention (T2), post-intervention (T3), and at 3-months post-intervention (T4). A qualitative exit interview will also be conducted post-intervention. This interview will be audio recorded. Video recording of the exit interview will be optional. Throughout both steps, parent testimonials that address barriers to accessing mental health services will be obtained to assist in Part 2 outreach and recruitment.

Part 1 will be conducted with parents experiencing elevated PGD symptoms as measured by the PG-13, a 13-item self-report scale evaluating the proposed diagnostic criteria of Prolonged Grief Disorder, including symptom severity, duration, and impairment. For this study, PG-13 scores ≥ 34 will be considered indicative of elevated PGD symptoms.

Part 2 will be used to obtain information about the feasibility, tolerability, acceptability, and effect size estimates of MCGT (delivered via video conferencing) to assist in planning a larger, efficacy RCT. These goals will be accomplished by undertaking a parallel-arm RCT comparing the refined MCGT to a standardized supportive psychotherapy (SP), both one-on-one interventions delivered via videoconferencing, which numerous studies show is as efficacious as in-person delivery.15-17 Parents (n=66) with PG-13 scores ≥ 34 will be randomized to receive MCGT or SP to compare their relative feasibility, acceptability, tolerability, and preliminary effects. As in Part 1, participants will be assessed pre-intervention (T1), mid-intervention (T2), post-intervention (T3), and at 3-months post-intervention (T4). All psychotherapy sessions for Part 1 will need to be completed before Part 2 begins. The investigators expect that they will be able to begin Part 2 of the protocol (during which recruits 66 parents) approximately 3 months after the final parent is enrolled in Part 1, Step 2. Approximately 66 parents (individuals) will complete the intervention in Part 2.Parents randomized to MCGT may also invite a support provider to join them for Session 9 (support provider n = 33). Support providers will not be evaluated as research participants.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Loss of a child who had been diagnosed with cancer between 6 months and 6 years ago as reported in the child's medical record or by parent report
  • Loss of a child 39 years old or younger as reported in the child's medical record or by parent report
  • Biological or adoptive parent or stepparent as reported in the child's medical record or by parent report
  • Parent must be age 18 or over as reported by parent
  • In the judgment of investigators/consenting professionals, able to comprehend English to complete study assessments
  • Score of 34 or greater ( ≥ 34) on the PG-13 at screening
  • Residing in New York, New Jersey, Connecticut, or Pennsylvania for P1S1; Residing in New York for P1S2; residing in New York or New Jersey or ability to complete sessions in New York or New Jersey for Part 2, as reported in the child's medical record or by parent report.

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
  • Must reside in New York or New Jersey or ability to complete sessions in New York or New Jersey

Exclusion Criteria:

  • Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude completion of the assessment measures, interview or 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
  • Another parent or primary caregiver of the child has been enrolled in the study
  • For the Part 2 RCT, participated in Part 1, Step 1 or 2.

Support Provider Exclusion Criteria:

  • Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude completion of the assessment measures, interview or 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02153619

Contacts
Contact: Wendy Lichtenthal, PhD 646-888-4812
Contact: William Breitbart, MD 646-888-0020

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Corrine Sweeny    646-888-0129      
Contact: Polly Korbel    646-888-0129      
Principal Investigator: Wendy Lichtenthal, PhD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
University of Memphis
University of Hawaii
Adelphi University
Weill Medical College of Cornell University
Investigators
Principal Investigator: Wendy Lichtenthal, PhD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02153619     History of Changes
Other Study ID Numbers: 14-102 
Study First Received: May 22, 2014
Last Updated: August 22, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center:
Grief
bereavement
questionnaires
therapy sessions
14-102

Additional relevant MeSH terms:
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 30, 2016