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NCT Number: NCT03454295

Easing Psychosocial Burden for Informal Caregivers

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Memorial Sloan Kettering Commack (Consent only), Commack, New York, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focus Group

Behavioral

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.

Meaning-Centered Psychotherapy for Cancer Caregivers / MCP-C

Behavioral

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

Enhanced Usual Care / EUC

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Improving Palliative Care of Caregivers of Patients With Glioblastoma

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Mar 5, 2018
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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