An interventional study of Managing Cancer and Living Meaningfully (CALM) Therapy in Mood and Cancer Brain, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Supportive care
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:
Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
psychotherapeutic intervention
Behavioral: Managing Cancer and Living Meaningfully (CALM) Therapy
6 sessions of individualized CALM therapy
Recruitment for CALM
Number of potential participants consented and enrolled
Time frame: 1 day
Completion of CALM Sessions
Number of participants completing CALM sessions
Time frame: 3 months
Post-session Assessment Completion
Number of participants completing post-session surveys
Time frame: 4 months
Follow-up Assessment Completion
Number of participants that completed a follow-up survey
Time frame: 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.
Time frame: 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.
Time frame: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 month - one timepoint
Number of Participants Likely to Recommend the Program to Others
Rating of the likelihood of recommending the program to others.
Time frame: 3 month timepoint
| Milestone | Therapy |
|---|---|
| Started | 14 |
| Completed | 9 |
| Not completed | 5 |
| Withdrew: Physician decision | 3 |
| Withdrew: Withdrawal by subject | 2 |
Number of potential participants consented and enrolled
| Participants | Therapy |
|---|---|
| Consented | 14 |
| Enrolled | 14 |
| Started intervention | 12 |
Number of participants completing CALM sessions
| Participants | Therapy |
|---|---|
| Completion of CALM Sessions | 9 |
Number of participants completing post-session surveys
| Participants | Therapy |
|---|---|
| Post-session Assessment Completion | 10 |
Number of participants that completed a follow-up survey
| Participants | Therapy |
|---|---|
| Follow-up Assessment Completion | 4 |
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.
| units on a scale | Therapy |
|---|---|
| Satisfaction With CALM Sessions | 4.6 (3 to 5) |
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.
| score on a scale | Therapy |
|---|---|
| Helpfulness of CALM Sessions | 4.6 (3 to 5) |
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.
| score on a scale | Therapy |
|---|---|
| Relevance of CALM | 4.6 (2 to 5) |
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.
| score on a scale | Therapy |
|---|---|
| Utility of CALM | 4.5 (3 to 5) |
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.
| score on a scale | Therapy |
|---|---|
| Intervention Satisfaction | 4.5 (3 to 5) |
Rating of the likelihood of recommending the program to others.
| Participants | Therapy |
|---|---|
| Will Recommend | 9 |
| Will not Recommend | 0 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Therapy | 0/9 (0%) | — | — |
| Age, Categorical(Participants) | Therapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 5 |
| Sex: Female, Male(Participants) | Therapy |
|---|---|
| Female | 11 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Therapy |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 14 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Therapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 13 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Therapy |
|---|---|
| United States | 14 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual level data will not be shared other researchers. Access to all data will be limited to study personnel.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Virginia Commonwealth University