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Easing Psychosocial Burden for Informal Caregivers

NCT03454295 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-04-01

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Allison Applebaum, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-12
Primary Completion
2024-03-26
Completion
2024-03-26

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03454295 on ClinicalTrials.gov