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Remote CALM therapy for participants with newly or recurrent PCNST

The CALM intervention is a brief, individualized psychotherapeutic intervention established to meet an unmet need to address psychological distress and promote well-being in advanced cancer patients.

CALM Therapy

Terri S Armstrong, C.R.N.P.

Background:

Psychological distress affects many people diagnosed with a primarym central nervous system tumor (CNST). Distress can include negative feelings such as anger, fear, or sadness. Researchers want to see if a type of therapy called CALM can help. It promotes well-being in people who have cancer that cannot be cured.

Objective:

To find out if the CALM therapy can help people with a CNST suffering from distress.

Eligibility:

English-speaking adults ages 18 and older who have a CNST and are taking part in NIH protocol #16C0151.

Design:

This study will not take place in person. It will be done by smartphone, computer, or tablet.

Participants will fill out 7 surveys. The surveys will take 40 to 60 minutes to complete. They are all electronic. They will ask about physical and emotional symptoms, depression, feelings about death and dying, feelings about close relationships, and general well-being.

Participants will be assigned to a CALM therapist. They will have 3 to 6 individual therapy sessions in 6 months. Each session will last 45 to 60 minutes. Sessions may be audio recorded. If needed, participants may have extra sessions.

CALM includes symptom management and discussions of meaning, purpose, and mortality.

Participants may have a family member take part in at least one CALM session with them.

After the third CALM session, participants will be asked questions about CALM.

After 3 and 6 months, participants will complete the 7 surveys again.

Participation will last about 6 months.

Background:

* Psychological distress is an emotional state experienced by primary central nervous system tumor (PCNST) patients throughout the illness trajectory. It can often be under identified in this patient population.
* Limited therapeutic interventions in managing distress symptoms can allow symptoms to linger without tailored mechanisms to manage the emotional challenges experienced with a tumor diagnosis. Individualized therapy in advanced cancer patients is a preferred method over pharmacological interventions when managing psychological distress, but more evidence-based research is needed to address the benefits.
* The CALM intervention is a brief, individualized psychotherapeutic intervention established to meet an unmet need to address psychological distress and promote well-being in advanced cancer patients. Previous studies implementing the CALM intervention have focused on metastatic and advanced cancer patients and have reported positive effects. Implementing the CALM intervention in a sample of PCNST patients will be one of the first studies to identify the preliminary effectiveness.

Objective:

-To demonstrate the effects of the CALM intervention in reduction of depressive symptoms using the PROMIS-Depression scale in PCNST participants, from baseline to 6 months.

Eligibility:

* Adult participants greater than or equal to 18 years of age with a PCNST diagnosis who are undergoing standard of care or experimental treatment.
* The ability of the subject to speak English
* Subjects who have a life expectancy of at least 3 months from time of study entry to allow for participation in the 3 required sessions.
* The ability of the subject to understand and willing to sign a written informed consent document as determined by the assessment of the clinical team.

Design:

* A total of 100 participants will be enrolled
* Neuro-Oncology participants being seen in the clinical center or receiving telehealth services will be screened to participate. Participants will be assigned a CALM therapist and all sessions will be completed remotely.

Data from standardized measures will be collected at 3 timepoints (Baseline, 3 months, 6 months) and qualitative interviews will be completed after the 3rd CALM session for a select number of participants until data saturation is reached (estimated to be 15-30).

-Approximate time for sessions is 45-60 minutes.

Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Brain Tumor

Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Central Nervous System Tumor

.All IPD recorded in the medical record will be shared with intramural investigators upon request.

To demonstrate the effects of the CALM intervention in reduction of depressive symptoms using the PROMIS-Depression scale in PCNST participants, from baseline to 6 months.

To demonstrate the short-term effects of the CALM intervention in reduction of depressive symptoms using the PROMIS-Depression scale in PCNST participants from baseline to 3 months.

To determine the effects of the CALM intervention on death anxiety at both 3 and 6 months, compared to baseline.

To describe the feasibility of implementing CALM remotely in a PCNST population, including eligibility, accrual, compliance, adverse effects, study completion, and participant satisfaction with the intervention.

National Cancer Institute (NCI)

Brain Diseases

Central Nervous System Diseases

Inform CALM adaptations for caregivers of patients with brain cancer.

The CALM intervention includes 3 to 6 individual therapy Zoom teletherapy sessions, each approximately 50-60 minutes in length biweekly, delivered over 3 months. Participants (caregivers) will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints:

Within one week before initiating the CALM intervention therapy (baseline) and immediately after the program (post-intervention)

In addition, after each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components.

Lastly, participants will complete an exit interview immediately following the end of the intervention.

Ashlee R Loughan, PhD

To conduct a mixed-method Phase Ia Define Trial of caregivers' participation in CALM therapy with post-session surveys and individual exit interviews in order to evaluate suitability and adapt the CALM intervention to the needs of caregivers in neuro-oncology.

Exploring caregivers' experiences of CALM intervention will inform more effective, targeted, supportive care for this traditionally underserved group in need of emotional support. We will use the data from this study to adapt the CALM intervention to the specific needs of caregivers in neuro-oncology

This study has been designed in accordance with the NIH Science of Behavior Change ORBIT model for developing behavioral interventions and represents a Phase Ia Define Trial.

Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers

Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers (AIM 2)

Utilizing post-session surveys, determine caregiver satisfaction (5-point Likert Scale) with 1) topic applicability; 2) perceived benefit of session; 3) comfort with interventionist(s); 4) overall satisfaction and 5) likelihood of recommending the program to others. Higher scores represent greater caregiver satisfaction with the CALM intervention.

Caregivers will be asked a number of open-ended questions about their recommendations to CALM during a semi-structured exit interview. Exit interviews will be audio recorded and transcribed verbatim. A co- investigator and a second independent coder will separately review each transcript to identify common themes and develop a coding framework of free responses. All results will be reviewed for agreement and comparison to the raw data, and discrepancies will be resolved through discussion with the PI until reliability is reached (Kappa\>.80).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Brain Tumor	NCT04852302	Depression	CALM Therapy	18 Years -	National Institutes of Health Clinical Center (CC)
Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers	NCT05590273	Caregivers Neuro-Oncology Brain Cancer	CALM Therapy	18 Years -	Virginia Commonwealth University

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