CompletedNot Applicable

CALM: Managing Distress in Malignant Brain Cancer

United States60 participantsStarted 2023-11-10

Plain-language summary

The purpose of this study is to test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM), compared to treatment as usual (TAU) in those with malignant brain cancer diagnoses.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Self-reported diagnosis of brain metastasis (bMET) or a malignant primary brain tumor (PBT; specifically grade III or IV and CNS diffuse large B cell lymphomas)\* * At least 2-weeks post-surgical resection or biopsy of the brain (if applicable) * Score \> 20 on the TICS * Reported elevated depression (PHQ-9 score ≥ 10) OR death anxiety symptoms (DADDS score ≥ 15) * Ability to read, speak, and understand English * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Major communication difficulties which would prohibit the psychotherapeutic interaction * Inability to meet with the interventionist via an electronic device for telehealth intervention sessions * Inability to understand and provide informed consent * Prisoners * Medical, psychological, or social condition that, in the opinion of the principal investigator, may increase the participant's risk of adverse events and/or prohibit the individual's participation in the intervention.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assess the feasibility of the CALM intervention- Screening Rate

Timeframe: Day 0

Assess the feasibility of the CALM intervention- Consent Rate

Timeframe: Day 0

Assess the feasibility of the CALM intervention- Intervention Retention Rate

Timeframe: 3 months

Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate

Timeframe: 3 months

Assess the feasibility of the CALM intervention- Follow-up Questionnaire Completion Rate

Timeframe: 6 months

Assess the acceptability of the CALM intervention- Participant Satisfaction

Timeframe: 4 months

Assess the acceptability of the CALM intervention- Participant Recommendation Ratings

Timeframe: 4 months

Trial details

NCT IDNCT06180460

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Brain Tumor trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Assess the feasibility of the CALM intervention- Screening Rate

Timeframe: Day 0

Assess the feasibility of the CALM intervention- Consent Rate

Timeframe: Day 0

Assess the feasibility of the CALM intervention- Intervention Retention Rate

Timeframe: 3 months

Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate

Timeframe: 3 months

Assess the feasibility of the CALM intervention- Follow-up Questionnaire Completion Rate

Timeframe: 6 months

Assess the acceptability of the CALM intervention- Participant Satisfaction

Timeframe: 4 months

Assess the acceptability of the CALM intervention- Participant Recommendation Ratings

Timeframe: 4 months