NCT03735498

Brief Summary

This research study is evaluating a psychological intervention for caregivers of loved ones with malignant gliomas.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

February 8, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

September 29, 2022

Completed
Last Updated

November 13, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

October 31, 2018

Results QC Date

July 12, 2022

Last Update Submit

October 17, 2024

Conditions

Malignant Glioma

Keywords

Malignant Gliomas

Outcome Measures

Primary Outcomes (2)

  • Feasibility of Caregiver Enrollment in the Intervention: Percentage of Eligible Caregivers Who Agree to Participate in the Study of This Intervention

    The investigators will report the percentage of eligible caregivers who agree to participate in the study of this intervention. The intervention will be deemed feasible if at least 70% (+/- 18%) of eligible caregivers are enrolled in the study.

    2 years

  • Feasibility of Caregiver Participation in a Population-specific Psychological Intervention: Percentage of Eligible Caregivers Who Participate in Each Session

    The investigators will report the percentage of eligible caregivers who participate in each session. Participation will be considered feasible if at least 70% of enrolled participants complete ≥50% of the sessions.

    2 years

Study Arms (1)

Psychological Intervention

EXPERIMENTAL

* Qualitative interview will be conducted * 7-item Generalized Anxiety Disorder measure will be completed by participants via mail correspondence or online * A psychoeducational component to address preparedness, manage expectations, and develop caregiving skills * A psychosocial component focusing on coping strategies, mindfulness, and facilitating acceptance while living with uncertainty * A self-care component to promote caregiver health and well-being

Other: Psychological Intervention

Interventions

Psychological InterventionOTHER

Promote effective coping and reduce caregiving burden

Psychological Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18
  • Identified by a patient with a malignant glioma (WHO Grade III or IV glioma) as the patient's primary caregiver
  • The patient is receiving care at the MGH Cancer Center
  • The patient was diagnosed with a malignant glioma within the past 6 months
  • Able to speak and read in English
  • Generalized Anxiety Disorder 7-item (GAD-7) score ≥5
  • Participants may or may not be pregnant.

You may not qualify if:

  • Deemed inappropriate for the study by the patient's clinician or the study PI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

MeSH Terms

Conditions

Glioma

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Deborah Forst
Organization
Massachusetts General Hospital
dforst@partners.org
617-724-8770

Study Officials

  • Deborah A. Forst, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 8, 2018

Study Start

February 8, 2019

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

November 13, 2024

Results First Posted

September 29, 2022

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)