CaregiversAIM 2NCT05590273
Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers
A study testing CALM Therapy in people with Caregivers and Neuro-Oncology, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregivers, Neuro-Oncology, Brain Cancer
- What is being tested?
- CALM Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2022to 28 Mar 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caregiver participants must be the caregiver of a brain cancer patient who is currently enrolled in DoD CA200896 (IRBHM20022755)
- Fluent in English
- Willing and able to attend a minimum of 3 CALM sessions via telehealth
- A caregiver is defined as the primary person who provides ongoing support to the brain cancer patient; it is not necessary that the caregiver lives with the patient or is related
- Patient participants must have enrolled in the linked HM20022755 study
Who cannot join
- Person does not consider themselves to be a caregiver of the patient
- Caregiver does not have a loved one (patient diagnosed with brain cancer) enrolled in DoDCA200896 (IRB HM20022755)
- Caregiver does not speak English
- Caregiver is unable to provide consent
- Caregiver does not have access to telehealth
- Caregiver is under the age of 18
- Professional caregivers who received financial compensation for their services are ineligible
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers (AIM 2)
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.
Read the detailed description
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
- Conditions
- Caregivers, Neuro-Oncology, Brain Cancer
- Being tested
- CALM Therapy
- Keywords
- CALM
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CALM TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Proof-of-concept trial | Experimental | Inform CALM adaptations for caregivers of patients with brain cancer. Receives: Behavioral: CALM Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate suitability of the CALM intervention to the needs of caregivers in neuro-oncology by measuring caregiver satisfaction.
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.
Measured: 3 months
Evaluate suitability of the CALM intervention to the needs of caregivers in neuro-oncology by measuring caregivers' recommendations to the content and format of the intervention during an exit-interview.
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start3 Nov 2022
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Why it stopped: Insufficient caregiver participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiversStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Foundation
- Responsible party
- Sponsor
- Investigators
- Ashlee R Loughan, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590273
- Sponsor's protocol ID
- MCC-22-19366
- Other IDs
- HM20024428
- Acronym
- AIM 2
- Status last verified
- Apr 2023
- First submitted
- 18 Oct 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers (AIM 2)
- ClinicalTrials.gov ID
- NCT05590273
- Acronym / sponsor ID
- AIM 2 / MCC-22-19366
- Conditions
- Caregivers, Neuro-Oncology, Brain Cancer
- Keywords
- CALM
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient caregiver participation
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- American Psychological Foundation
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Proof-of-concept trial | Experimental | Behavioral: CALM TherapyInform CALM adaptations for caregivers of patients with brain cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Caregiver participants must be the caregiver of a brain cancer patient who is currently enrolled in DoD CA200896 (IRBHM20022755)
- Fluent in English
- Willing and able to attend a minimum of 3 CALM sessions via telehealth
- A caregiver is defined as the primary person who provides ongoing support to the brain cancer patient; it is not necessary that the caregiver lives with the patient or is related
- Patient participants must have enrolled in the linked HM20022755 study
Key exclusion criteria (7 listed)
- Person does not consider themselves to be a caregiver of the patient
- Caregiver does not have a loved one (patient diagnosed with brain cancer) enrolled in DoDCA200896 (IRB HM20022755)
- Caregiver does not speak English
- Caregiver is unable to provide consent
- Caregiver does not have access to telehealth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CALM TherapyThe 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. | Behavioural | Proof-of-concept trial |
Primary outcome
Evaluate suitability of the CALM intervention to the needs of caregivers in neuro-oncology by measuring caregiver satisfaction.
Time frame: 3 months
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.
Evaluate suitability of the CALM intervention to the needs of caregivers in neuro-oncology by measuring caregivers' recommendations to the content and format of the intervention during an exit-interview.
Time frame: 3 months
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).
Results and safety
The study was stopped early (reason given: Insufficient caregiver participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashlee R Loughan, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CALM Therapy in people with Caregivers and Neuro-Oncology, run by Virginia Commonwealth University 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 3 May 2023. 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 was stopped early (reason given: Insufficient caregiver participation). Results are not available in the source record.
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?
Evaluate suitability of the CALM intervention to the needs of caregivers in neuro-oncology by measuring caregiver satisfaction. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2023.