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| ID | Type | Description | Link |
|---|---|---|---|
| HM20020308 | Other Identifier | Virginia Commonwealth University |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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The purpose of this study is to pilot test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM). Researchers hope to better understand the potential benefits of this intervention on brain tumor patients' mood and quality of life. This may lead to improvements in doctor's understanding of how to enhance brain tumor patient's wellbeing and overall functioning.
In this study, participants will be asked to do the following things:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy | Experimental | psychotherapeutic intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Managing Cancer and Living Meaningfully (CALM) Therapy | Behavioral | 6 sessions of individualized CALM therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment for CALM | Number of potential participants consented and enrolled | 1 day |
| Completion of CALM Sessions | Number of participants completing CALM sessions | 3 months |
| Post-session Assessment Completion | Number of participants completing post-session surveys | 4 months |
| Follow-up Assessment Completion | Number of participants that completed a follow-up survey | 6 months |
| Satisfaction With CALM Sessions | Average rating of CALM session satisfaction score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all satisfied and 5 being very much satisfied. Higher scores indicate greater satisfaction. | Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12 |
| Helpfulness of CALM Sessions | Average rating of CALM session helpfulness score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all helpful and 5 being very much helpful. Higher scores indicate greater helpfulness. | Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12 |
| Relevance of CALM |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashlee Loughan, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35437687 | Derived | Loughan AR, Willis KD, Braun SE, Rodin G, Lanoye A, Davies AE, Svikis D, Mazzeo S, Malkin M, Thacker L. Managing cancer and living meaningfully (CALM) in adults with malignant glioma: a proof-of-concept phase IIa trial. J Neurooncol. 2022 May;157(3):447-456. doi: 10.1007/s11060-022-03988-8. Epub 2022 Apr 18. |
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Individual level data will not be shared other researchers. Access to all data will be limited to study personnel.
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| ID | Title | Description |
|---|---|---|
| FG000 | Therapy | psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Therapy | psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment for CALM | Number of potential participants consented and enrolled | Posted | Count of Participants | Participants | 1 day |
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6 months
Adverse events and Serious adverse events were not collected for this trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Therapy | psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ashlee Loughan | Virginia Commonwealth University | 804-828-4178 | ashlee.loughan@vcuhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2020 | Aug 15, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 19, 2020 | May 13, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Average rating of CALM session relevance score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all relevant and 5 being very much relevant. Higher scores indicate greater helpfulness.
| Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12 |
| Utility of CALM | Average rating of CALM session utility score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all useful and 5 being very much useful. Higher scores indicate greater helpfulness. | Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12 |
| Intervention Satisfaction | Mean rating of intervention satisfaction score (average score across all participants who completed the CALM intervention - one timepoint). Rating option is a range from 1 to 5 with 1 being not at all satisfied and 5 being very much satisfied. Higher scores indicate greater satisfaction. | 3 month - one timepoint |
| Number of Participants Likely to Recommend the Program to Others | Rating of the likelihood of recommending the program to others. | 3 month timepoint |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Completion of CALM Sessions | Number of participants completing CALM sessions | Posted | Count of Participants | Participants | 3 months |
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| Primary | Post-session Assessment Completion | Number of participants completing post-session surveys | Posted | Count of Participants | Participants | 4 months |
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| Primary | Follow-up Assessment Completion | Number of participants that completed a follow-up survey | Posted | Count of Participants | Participants | 6 months |
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| Primary | Satisfaction With CALM Sessions | Average rating of CALM session satisfaction score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all satisfied and 5 being very much satisfied. Higher scores indicate greater satisfaction. | Of the 12 intervention initiators | Posted | Mean | Full Range | units on a scale | Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12 |
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| Primary | Helpfulness of CALM Sessions | Average rating of CALM session helpfulness score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all helpful and 5 being very much helpful. Higher scores indicate greater helpfulness. | Of the 12 intervention initiators | Posted | Mean | Full Range | score on a scale | Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12 |
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| Primary | Relevance of CALM | Average rating of CALM session relevance score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all relevant and 5 being very much relevant. Higher scores indicate greater helpfulness. | Of the 12 trial initiators | Posted | Mean | Full Range | score on a scale | Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12 |
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| Primary | Utility of CALM | Average rating of CALM session utility score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all useful and 5 being very much useful. Higher scores indicate greater helpfulness. | of the 12 trial initiators | Posted | Mean | Full Range | score on a scale | Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12 |
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| Primary | Intervention Satisfaction | Mean rating of intervention satisfaction score (average score across all participants who completed the CALM intervention - one timepoint). Rating option is a range from 1 to 5 with 1 being not at all satisfied and 5 being very much satisfied. Higher scores indicate greater satisfaction. | of the 9 intervention completers | Posted | Mean | Full Range | score on a scale | 3 month - one timepoint |
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| Primary | Number of Participants Likely to Recommend the Program to Others | Rating of the likelihood of recommending the program to others. | of the 9 intervention completers | Posted | Count of Participants | Participants | 3 month timepoint |
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| 0 |
| 9 |
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| 0 |
| 0 |
| 0 |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |