Cancer Brain, Mood
Conditions
Brief summary
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.
Detailed description
In this study, participants will be asked to do the following things: 1. Complete \ 15-minute online surveys before the program, immediately after the program (4 months), and at follow-up (6 months). . Questions will ask about mood, anxiety, death distress, quality of social relationships, and satisfaction with life. 2. Meet with an interventionist six times (biweekly) for individual sessions via Zoom, lasting 50-60 minutes each. Sessions will be audio-recorded to ensure all participants receive the same information. Participants will be asked to only use first names. 3. Complete weekly \ 5 minute online surveys after each session on satisfaction with the program. 4. Complete an exit interview by telephone approximately 1 month after the 6-session intervention. This exit interview will last approximately 15-30 minutes.
Interventions
BEHAVIORALManaging Cancer and Living Meaningfully (CALM) Therapy
6 sessions of individualized CALM therapy
Sponsors
American Cancer Society, Inc.
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* have a confirmed malignant brain cancer diagnosis via histopathology * be a minimum of 2 weeks post-surgical resection or biopsy (if applicable) * be primarily English speaking * be age 18-89 * obtain \>20 on the Telephone Interview for Cognitive Status (TICS) * have current elevated depression or death anxiety symptoms * have a reliable internet connection to participate in the Zoom therapy sessions
Exclusion criteria
* Major communication difficulties as determined by the research team which would prohibit psychotherapeutic interaction * inability to meet with interventionist via an electronic device for telehealth intervention sessions * inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment for CALM | 1 day | Number of potential participants consented and enrolled |
| Completion of CALM Sessions | 3 months | Number of participants completing CALM sessions |
| Post-session Assessment Completion | 4 months | Number of participants completing post-session surveys |
| Follow-up Assessment Completion | 6 months | Number of participants that completed a follow-up survey |
| Satisfaction With CALM Sessions | Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12 | 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. |
| Helpfulness of CALM Sessions | Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12 | 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. |
| Relevance of CALM | Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12 | 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. |
| Utility of CALM | Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12 | 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. |
| Intervention Satisfaction | 3 month - one timepoint | 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. |
| Number of Participants Likely to Recommend the Program to Others | 3 month timepoint | Rating of the likelihood of recommending the program to others. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Therapy psychotherapeutic intervention
Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Completion of CALM Sessions
Number of participants completing CALM sessions
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Therapy | Completion of CALM Sessions | 9 Participants |
Primary
Follow-up Assessment Completion
Number of participants that completed a follow-up survey
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Therapy | Follow-up Assessment Completion | 4 Participants |
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.
Time frame: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Population: Of the 12 intervention initiators
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Therapy | Helpfulness of CALM Sessions | 4.6 score on a scale |
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.
Time frame: 3 month - one timepoint
Population: of the 9 intervention completers
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Therapy | Intervention Satisfaction | 4.5 score on a scale |
Primary
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
Population: of the 9 intervention completers
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Therapy | Number of Participants Likely to Recommend the Program to Others | Will Recommend | 9 Participants |
| Therapy | Number of Participants Likely to Recommend the Program to Others | Will not Recommend | 0 Participants |
Primary
Post-session Assessment Completion
Number of participants completing post-session surveys
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Therapy | Post-session Assessment Completion | 10 Participants |
Primary
Recruitment for CALM
Number of potential participants consented and enrolled
Time frame: 1 day
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Therapy | Recruitment for CALM | Consented | 14 Participants |
| Therapy | Recruitment for CALM | Enrolled | 14 Participants |
| Therapy | Recruitment for CALM | Started intervention | 12 Participants |
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.
Time frame: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Population: Of the 12 trial initiators
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Therapy | Relevance of CALM | 4.6 score on a scale |
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.
Time frame: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Population: Of the 12 intervention initiators
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Therapy | Satisfaction With CALM Sessions | 4.6 units on a scale |
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.
Time frame: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Population: of the 12 trial initiators
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Therapy | Utility of CALM | 4.5 score on a scale |