Brain Cancer, Brain Metastases, Brain Tumor, Metastatic Breast Cancer, Metastatic Colon Cancer, Metastatic Kidney Cancer, Metastatic Lung Cancer, Metastatic Melanoma
Conditions
Keywords
Service Members, Veterans
Brief 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.
Interventions
BEHAVIORALCALM
The CALM intervention is a supportive-expressive therapy that is administered by CALM trained clinicians in a particular style.
BEHAVIORALTreatment as usual
Treatment as usual includes a list of local / national resources (e.g., psychologist, social worker, or other mental health providers) if an individual chooses to seek treatment for the distress they are experiencing.
Sponsors
United States Department of Defense
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the feasibility of the CALM intervention- Screening Rate | Day 0 | Percent of interested individuals who undergo screening |
| Assess the feasibility of the CALM intervention- Consent Rate | Day 0 | Percent of eligible individuals who consent to the trial |
| Assess the feasibility of the CALM intervention- Intervention Retention Rate | 3 months | Percent of consented individuals who complete the CALM intervention |
| Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate | 3 months | Percent of consented individuals who complete post-intervention questionnaires |
| Assess the feasibility of the CALM intervention- Follow-up Questionnaire Completion Rate | 6 months | Percent of consented individuals who complete follow-up questionnaires |
| Assess the acceptability of the CALM intervention- Participant Satisfaction | 4 months | Satisfaction ratings from participants during exit interview (e.g., Rate your overall benefit on a scale of 1-5). |
| Assess the acceptability of the CALM intervention- Participant Recommendation Ratings | 4 months | Percent of participants who would recommendation CALM to others will be assessed during the exit interview (e.g., Would you recommend this program to others?) |
Countries
United States
Outcome results
None listed