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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 15, 2014
Last verified: September 2014
  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 a Parent 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 [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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

  • psychological outcome data [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    in prolonged grief symptoms, assessed with the PG-13 summary score.


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. All participants (n = 5 for Step 1 and n = 5 for Step 2) will receive 16 one-hour weekly sessions MCGT, and all therapy sessions will be audio recorded. If the participant provides us with permission, we will also video record the sessions. The main assessments for this study will be administered at four time points: pre-intervention (T1), mid-intervention (T2), post-intervention (T3), and at a 3-month follow-up (T4). Participants will provide their feedback about MCGT and the measures. The PI will review the open trial sessions to help refine the MCGT manual and treatment integrity forms. Sessions for Step 1 participants in Part 1 will be held at the MSKCC Counseling Center. Sessions for Step 2 participants in Part 1 will be conducted via videoconferencing. Explicit instructions, training, and technical support for videoconferencing will be provided by our trained therapists.
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.
Behavioral: questionnaires assessments
Experimental: MCGT or Supportive Psychotherapy
Part 2: Pilot RCT. We will randomize 66 parents to 16 weekly one-hour sessions of MCGT or SP delivered via videoconferencing. Again, all sessions will be audio recorded. If the participant provides us with permission, we will also video record the sessions. We will examine aspects of study implementation and therapy process, including a) recruitment progress, b) implementation of the intervention, c) administration of the assessments, and d) retention. We will also examine acceptability, defined as measures of satisfaction at T3. Psychosocial outcomes will be assessed with self-report measures at four timepoints: pre-intervention (T1), mid-intervention (T2), post-intervention (T3), and at a 3-month follow-up (T4).
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.
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.

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.

Step 1 will need to be completed before Step 2 begins. All Part 1 participants will be assessed pre-intervention (T1), mid-intervention (T2), post-intervention (T3), and at a 3-month follow-up (T4). 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 > or = to 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 a 3-month follow-up (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 enrolled in Part 1, Step 2 completes the intervention. Approximately 66 parents (individuals) will complete the intervention in Part 2.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Loss of a child to cancer between 6 months and 6 years ago
  • Loss of a child 25 years old or younger
  • 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
  • Score of 34 or greater (> or = to 34) on the PG-13 at screening
  • Residing in New York, New Jersey, Connecticut, or Pennsylvania for P1S1; Residing in New York State for P1S2 and Part 2.

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
  • 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.
  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:
No publications provided

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: September 15, 2014
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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014