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Malignant GliomaNCT04109209

Psychological Intervention For Brain Tumor Caregivers

A study testing Psychosocial Intervention Group in people with Malignant Glioma and Anxiety, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is testing a supportive psychosocial intervention for caregivers of people who have malignant brain tumors such as gliomas or other high-grade primary brain tumors. This study was designed because caregivers of patients with malignant brain tumors often experience physical and psychological burdens caring… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Malignant Glioma, Anxiety, Caregiver Burden
What is being tested?
Psychosocial Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
9 Oct 2019to 13 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18
  • Identified by study staff, a clinician, self, or a patient with a malignant brain tumor as the patient's primary caregiver
  • The patient is receiving care at the MGH Cancer Center
  • The patient was diagnosed with a malignant brain tumor 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.

Who cannot join

  • Deemed inappropriate for the study by the patient's clinician or the study PI
  • Participated in the pilot study of this caregiver intervention (DF/HCC 18-426)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: NeuroCARE: Psychological Intervention for Caregivers of Patients With Malignant Gliomas (RCT)

This study is testing a supportive psychosocial intervention for caregivers of people who have malignant brain tumors such as gliomas or other high-grade primary brain tumors. This study was designed because caregivers of patients with malignant brain tumors often experience physical and psychological burdens caring for their loved ones.

The purpose of this study is to find out whether a program offering psychological support can help caregivers learn effective coping methods during their loved one's treatment and make the experience of being a caregiver more manageable.

Read the detailed description

This study will be a prospective, randomized controlled trial to assess the efficacy of a caregiver-directed intervention designed to improve anxiety in caregivers of patients with malignant brain tumors, in comparison with caregivers who receive usual care.

The aim of this study is to test the efficacy of this intervention in reducing distress in caregivers of patients with malignant brain tumors, in comparison with usual care. The study will be conducted in 120 caregivers.

Being tested
Psychosocial Intervention Group, Usual Care Group
Keywords
Malignant Glioma, Caregiver Anxiety, Caregiver Burden, Psychological distress, Brain Tumor
Medical subject headings
Glioma, Anxiety Disorders, Caregiver Burden, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychosocial Intervention GroupBehavioural

    The intervention will consist of six one-on-one sessions (45 minutes each). Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks

  • Usual Care GroupBehavioural

    Caregivers randomized to the usual care arm will be referred to the brain tumor clinic social worker or other appropriate cancer center resources upon request from the caregiver, patient or clinician

    •Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks

Study groups in NCT04109209
Study groupRoleWhat they receive
Usual Care GroupActive comparator* 60 Participants will be randomized to receive usual care for caregivers of patients with malignant brain tumors * Caregivers randomized to the usual care arm will be referred to the brain tumor clinic social worker or other appropriate cancer center resources upon request from the caregiver, patient or clinician * Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks
Receives: Behavioral: Usual Care Group
Psychosocial Intervention GroupExperimental* 60 Participants of caregivers of patients with malignant brain tumors will be randomized into the psychosocial intervention arm * Caregivers assigned to the intervention arm will receive usual care and the psychosocial intervention. The intervention entails six one-on-one sessions with an interventionist (psychologist or social worker) * Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks
Receives: Behavioral: Psychosocial Intervention Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety symptoms

    We will compare anxiety symptoms using the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS-A) between the intervention and usual care group. The HADS-A is a 7-item subscale with scores ranging from 0 to 21, with higher scores indicating higher levels of anxiety.

    Measured: 11 weeks

Secondary outcomes (7)

  1. Anxiety symptoms longitudinally

    We will compare anxiety symptoms using the Anxiety subscale of the hospital anxiety and depression scale (HADS-A) between the two groups longitudinally. HADS-A is the 7-item anxiety subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating higher levels of anxiety.

    Measured: Up to 16 weeks

  2. Self-Efficacy

    Comparison of the effect of the intervention on caregiver self-efficacy (CASE) between study groups . The Lewis Cancer Self-Efficacy Scale (CASE) is a 17-item scale that measures caregivers' confidence in managing the impact of their loved one's illness from. Score range from 0 to 170. Higher scores indicate higher self-efficacy.

    Measured: Up to 16 weeks

  3. Coping skills

    We will compare coping skills between study arms using the Measure of Current Status Part A (MOCS-A). The MOCS-A assesses caregivers' self-perceived status on coping skills targeted by the intervention. Total MOCS-A scores range from 0-52 with higher scores indicating better self-perceived coping skills.

    Measured: Up to 16 weeks

  4. Quality of life using the Caregiver quality of life oncology questionnaire

    Comparison of caregiver quality of life (CarGOQoL) between study groups. The CareGiver Oncology QoL questionnaire (CarGOQoL) is a 29-item, well-validated instrument specific to caregivers for patients with cancer, used to measure family caregiver QoL in multiple domains. Overall scores range from 0 to 100, with higher scores corresponding to higher quality of life.

    Measured: Up to 16 weeks

  5. Caregiver burden

    Comparison of caregiver burden (CRA) between study groups.

    • Caregiving burden will be measured using the Caregiver Reaction Assessment (CRA), a 24-item scale measuring caregiving burden with score range of 24-120. Higher scores indicate higher caregiving burden.

    Measured: Up to 16 weeks

  6. Depression symptoms

    Comparison of the effect of the intervention on depression symptoms (HADS-D) between study groups. HADS-D is the 7-item depression subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating higher levels of depression.

    Measured: Up to 16 weeks

  7. PTSD symptoms

    Comparison of post-traumatic stress disorder (PTSD) symptoms between study groups . PTSD symptoms will be measured using the PCL-5, a 20-item questionnaire with scores ranging from 0-80; higher scores indicate more severe PTSD symptoms.

    Measured: Up to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2019
  2. Study start9 Oct 2019
  3. Primary completion13 Sep 2022
  4. Study completion13 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04109209
Sponsor's protocol ID
19-250
Status last verified
Dec 2024
First submitted
26 Sep 2019
Last updated
5 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Publications

  • Forst DA, Podgurski AF, Strander SM, Whitman JD, Datta S, Pintro K, Horick NK, Willis KD, Sannes TS, Greer JA, El-Jawahri A, Jacobs JM, Temel JS. NeuroCARE: A Randomized Controlled Trial of a Psychological Intervention for Caregivers of Patients With Primary Malignant Brain Tumors. J Clin Oncol. 2024 Dec 20;42(36):4252-4262. doi: 10.1200/JCO.24.00065. Epub 2024 Sep 16.

    PubMed 39284103

  • Forst DA, Rhee JY, Mesa MM, Podgurski AF, Strander SM, Datta S, Kaslow-Zieve E, Horick NK, Greer JA, El-Jawahri A, Sannes TS, Temel JS, Jacobs J. Study protocol for NeuroCARE: a randomised controlled trial of a psychological intervention for caregivers of patients with primary malignant brain tumours. BMJ Open. 2023 Sep 7;13(9):e069410. doi: 10.1136/bmjopen-2022-069410.

    PubMed 37678946

Questions about this trial

What is this clinical trial studying?

A study testing Psychosocial Intervention Group in people with Malignant Glioma and Anxiety, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety symptoms (time frame: 11 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04109209, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.

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