Easing Psychosocial Burden for Informal Caregivers

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ClinicalTrials.gov Identifier: NCT03454295

Recruitment Status : Active, not recruiting

First Posted : March 5, 2018

Last Update Posted : December 16, 2021

Sponsor:

Information provided by (Responsible Party):

Memorial Sloan Kettering Cancer Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Glioblastoma	Behavioral: Focus Group Behavioral: Meaning-Centered Psychotherapy for Cancer Caregivers / MCP-C Behavioral: Enhanced Usual Care / EUC	Early Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	64 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Improving Palliative Care of Caregivers of Patients With Glioblastoma
Actual Study Start Date :	February 12, 2018
Estimated Primary Completion Date :	August 2022
Estimated Study Completion Date :	August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Genetic and Rare Diseases Information Center resources: Glioblastoma Glioma Neuroepithelioma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.	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.
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.	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.

Arm

Intervention/treatment

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.

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.

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.

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.

Outcome Measures

Primary Outcome Measures :

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).

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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 caregiver of the patient is currently enrolled in the study, will be offered referrals to the MSKCC Counseling Center and to local mental health providers

Contacts and Locations

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): NCT03454295

Locations

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United States, New York
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, United States, 11725
Memoral Sloan Kettering Westchester (Consent only)
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

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Principal Investigator:	Allison Applebaum, PhD	Memorial Sloan Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center This link exits the ClinicalTrials.gov site

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Responsible Party:	Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT03454295
Other Study ID Numbers:	18-075
First Posted:	March 5, 2018 Key Record Dates
Last Update Posted:	December 16, 2021
Last Verified:	December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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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:


Cancer Caregivers Caregiver Caregivers Memorial Sloan Kettering Cancer Center 18-075

Additional relevant MeSH terms:

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Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors	Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue

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