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Easing Psychosocial Burden for Informal Caregivers

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ClinicalTrials.gov Identifier: NCT03454295
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE February 14, 2018
First Posted Date  ICMJE March 5, 2018
Last Update Posted Date January 13, 2020
Actual Study Start Date  ICMJE February 12, 2018
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
  • Feasibility of Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) delivered to caregivers of participants with GBM [ Time Frame: 1 year ]
    Feasibility will be measured by our ability to recruit our target sample of 60 ICs within the 1-year enrollment period. Our feasibility target for completion of follow-up assessments if 80% at T2 and 60% at T3, based on typical assessment completion rates in other psychosocial intervention studies conducted at our institution.
  • Acceptability of Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) delivered to caregivers of participants with GBM [ Time Frame: 1 year ]
    Acceptability will be informed by the MCP-C completion rate and Phase 2 semi-structured interviews (deemed acceptable if at least 40% complete all psychotherapy sessions).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Easing Psychosocial Burden for Informal Caregivers
Official Title  ICMJE Improving Palliative Care of Caregivers of Patients With Glioblastoma
Brief Summary The overall goal of this study is to determine the best time to offer Meaning-Centered Psychotherapy (MCP), an intervention that has proven to be helpful in improving spiritual well-being and decreasing existential distress among patients with advanced cancer, to caregivers. (MCP has also been shown to be an appropriate method of attending to the palliative or comfort care needs of caregivers of patients with cancer. Studies show that the psychological burden associated with caring for a patient with advanced cancer is often greater than that experienced by the patients themselves.) The investigators would also like to find out about caregivers initial impressions of MCP-C, Meaning-Centered Psychotherapy for Cancer Caregivers, so that the intervention can be adjusted to meet the unique needs of caregivers of patients with Glioblastoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • Behavioral: Focus Group
    Participants will be asked to reflect on their caregiving experience and specifically, when the receipt of a supportive intervention that addresses existential distress would have been most appropriate and well received.
  • Behavioral: Meaning-Centered Psychotherapy for Cancer Caregivers / MCP-C
    MCP-C is structured as a 7-session (1-hour weekly or biweekly sessions) individual intervention that utilizes a mixture of didactics, discussion and experiential exercises that focus around particular themes related to meaning and cancer caregiving
  • Behavioral: Enhanced Usual Care / EUC
    The "enhancement" to usual care in this study involves the inclusion of screening and targeted referral components as suggested by Reynolds et al. [79]. Research study assistants conducting the screening and providing feedback and referrals will be trained in the NCCN guidelines for distress management and will discuss the screening results and associated recommendations with the study PI (NCCN) [63]. As of November, 2017, ICs of patients seen in the Neurology Service at MSKCC are not consistently screened for distress and offered targeted referrals. Participants randomized to EUC will receive feedback about their level of distress (based on the Distress Thermometer administered at screening) after randomization. Within a week of randomization, and post-baseline, the study RSA will send EUC participants appropriate targeted referrals based on levels of distress and problem areas endorsed.
Study Arms  ICMJE
  • Experimental: Part I
    Focus group (Part 1) of four to ten GBM ICs bereaved at least one year to help determine our recruitment strategy. Participants will be asked to reflect on their caregiving experience and specifically, when the receipt of a supportive intervention that addresses existential distress would have been most appropriate and well received. Should consensus among participants be reached (e.g., if the majority report that being approached at time of their loved one's cancer recurrence would have been the optimal time for enrollment), we will target our enrollment timeline to this point (and this timeline will be reflected in amended inclusion criteria). If no consensus is reached, the study staff will enroll ICs at all points in the caregiving trajectory and revisit the appropriateness of various points of contact during the Part 2 individual interviews.
    Intervention: Behavioral: Focus Group
  • Experimental: Part II
    In Part 2, we will recruit 60 ICs of patients with GBM who will be randomized to receive either MCP-C or EUC. MCP-C will be delivered individually over 7 1-hour-long sessions within 7 - 14 weeks.
    Interventions:
    • Behavioral: Meaning-Centered Psychotherapy for Cancer Caregivers / MCP-C
    • Behavioral: Enhanced Usual Care / EUC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 2, 2018)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Part I Focus group GBM informal caregivers (ICs):

  • English-speaking as English proficiency screener and in the best judgment of the consenting professional. This is due to the focus groups being managed in English and the use of certain validated questionnaires only being available in English.
  • Age > 18
  • IC to an MSKCC patient with GBM who died a year or more ago

Part II Randomized Intervention of GBM ICs:

  • English-speaking as per English proficiency screener and in the best judgment of the consenting professional
  • Current ICs to a patient with GBM
  • Age ≥ 18
  • Score of > 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the caregiving role per self-report

Exclusion Criteria:

  • In the judgment of the consenting professional, clinician or PI and/or as per medical record, severe psychopathology or cognitive impairment likely to interfere with the participation or completion of the protocol or ability to provide meaningful information
  • Another family member of caregiver to the same patients is currently enrolled in the study
  • Ultimately, if interested, all caregivers who decline participation or are ineligible for the study for any reason, including because another caregives of the patient is currently enrolled in the study, will be offered referrals to the MSKCC Counseling Center and to local mental health providers
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Allison Applebaum, PhD 646-888-0034 ApplebaA@mskcc.org
Contact: Eli Diamond, MD 212-610-0243 diamone1@mskcc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03454295
Other Study ID Numbers  ICMJE 18-075
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Allison Applebaum, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP