Easing Psychosocial Burden for Informal Caregivers

NCT ID: NCT03454295

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-12
• Study Completion Date: 2024-03-26

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.

Conditions

Glioblastoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Focus Group

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Meaning-Centered Psychotherapy for Cancer Caregivers / MCP-C

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allison Applebaum, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

18-075

Identifier Type: -

Identifier Source: org_study_id