Managing Distress in Malignant Brain Cancer
Study Details
Study Description
Brief Summary
To identify potential adaptations of the managing cancer and living meaningfully (CALM) intervention that will be required for service members, Veterans, their beneficiaries, and civilian cancer metastasis to the brain (bMET) populations.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The first study is a single-arm, mixed-methods, Phase IIa, proof-of-concept trial to inform CALM adaptations for service members (SMs), Veterans, their beneficiaries, and civilians with bMET. Upon completion of the Phase IIa trial, a 2-year multi-arm randomized Phase IIb Pilot Trial will be conducted.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Proof-of-concept trial Inform CALM adaptations for SMs, Veterans, their beneficiaries, and civilians with cancer metastasis to the brain (bMET) |
Behavioral: CALM Intervention
The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants 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
Within one week after its completion,
3 months after the CALM intervention is complete
After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components
|
| Experimental: Primary Brain Tumor (PBT) CALM Intervention CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone. |
Behavioral: CALM Intervention
The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants 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
Within one week after its completion,
3 months after the CALM intervention is complete
After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components
|
| Active Comparator: Primary Brain Tumor (PBT) Treatment as Usual (TUC) Control Survey Administration. Participants will be asked to complete self-report surveys of behavioral and psychological variables. |
Behavioral: Survey Administration
Participants will be asked to complete self-report surveys of behavioral and psychological variables at the following timepoints:
Within one week before initiating the treatment as usual
Within one week after its completion,
3 months after the treatment as usual is complete
|
| Experimental: Cancer Metastasis to the Brain (bMET) CALM Intervention CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone. |
Behavioral: CALM Intervention
The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants 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
Within one week after its completion,
3 months after the CALM intervention is complete
After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components
|
| Active Comparator: bMET TUC Control Survey Administration. Participants will be asked to complete self-report surveys of behavioral and psychological variables. |
Behavioral: Survey Administration
Participants will be asked to complete self-report surveys of behavioral and psychological variables at the following timepoints:
Within one week before initiating the treatment as usual
Within one week after its completion,
3 months after the treatment as usual is complete
|
Outcome Measures
Primary Outcome Measures
- Assess the need for adaptations to the CALM intervention by conducting exit interviews and performing thematic analysis on interview data in proof of concept project. [4 Months]
Exit interviews will be audio recorded and transcribed verbatim via Dragon Software. 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).
- Assess the need for adaptations to the CALM intervention by conducting exit interviews and performing thematic analysis on interview data in the pilot trial. [4 Months]
Exit interviews will be audio recorded and transcribed verbatim via Dragon Software. 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).
- Feasibility of CALM intervention in the Proof of Concept project as measured by the rates of participant screening, eligibility, and consent. [12 months]
Determine how many patients consent to screening after referral to the program, how many patients are eligible for the program after being screened, and how many consent/enroll in the program if eligible.
- Feasibility of CALM intervention in the Pilot Trial as measured by the rates of participant screening. [12 months]
Determine how many patients consent to screening after referral to the program.
- Feasibility of CALM intervention in the Pilot Trial as measured by the rates of participant eligibility [12 Months]
Determine how many patients consent to screening after referral to the program, how many patients are eligible for the program after being screened
- Feasibility of CALM intervention in the Pilot Trial as measured by the rates of participant consent. [12 Months]
Determine how many patients consent to screening after referral to the program, how many consent to enroll in the program if eligible.
- Feasibility of CALM intervention in the Proof of Concept project as measured by attendance at CALM sessions [3 Months]
Percent of sessions attended
- Feasibility of CALM intervention in the Pilot trial as measured by attendance at CALM sessions for participants in the CALM Intervention arms. [3 Months]
Percent of sessions attended
- Feasibility of CALM intervention in the Proof of Concept project as measured by the rates of post-session assessment completion [3 Months]
Percent of post-session surveys completed by participants immediately after the intervention
- Feasibility of CALM intervention in the Pilot Trial as measured by the rates of post-session assessment completion for participants in the CALM Intervention arms. [3 Months]
Percent of post-session surveys completed by participants immediately after the intervention
- Feasibility of CALM intervention in the Proof of Concept project as measured by follow-up assessment completion [6 Months]
Percent of follow-up surveys completed by participants three months after the intervention
- Feasibility of CALM intervention in the Pilot Trial as measured by follow-up assessment completion [6 Months]
Percent of follow-up surveys completed by participants three months after the intervention
- Satisfaction with intervention (acceptability) in the Proof of concept project as measured by participant responses to researcher-developed questions (e.g., How satisfied were you with the program overall?) measured on a 5-point Likert scale [7 Months]
Acceptability will be assessed by participant satisfaction. After each intervention session, participants will be sent a link for a brief post-session satisfaction survey via secure email link. In this survey, participants will rate 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.
- Satisfaction with intervention (acceptability) in the pilot trial as measured by participant responses to researcher-developed questions (e.g., How satisfied were you with the program overall?) measured on a 5-point Likert scale [7 Months]
Acceptability will be assessed by participant satisfaction. After each intervention session, participants will be sent a link for a brief post-session satisfaction survey via secure email link. In this survey, participants will rate 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.
Secondary Outcome Measures
- Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in depression as measured by Patient Health Questionnaire - 9 Item (PHQ9) in the Proof of Concept project. [6 months]
Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report inventory measures depressive symptoms. Derived from the validated full Patient Health Questionnaire, the PHQ-9 asks participants to rate frequency of their depressive symptoms over the previous two weeks using a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). Total scores (summing all items) range from 0-27. Guidelines for score interpretation suggest: 0-5 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and >20 severe depression.
- Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in suicidal ideation as measured by Patient Health Questionnaire - 9 Item (PHQ9) in the Proof of Concept project. [6 months]
Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report inventory measures depressive symptoms. Derived from the validated full Patient Health Questionnaire, the PHQ-9 asks participants to rate frequency of their depressive symptoms over the previous two weeks using a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). Total scores (summing all items) range from 0-27. Guidelines for score interpretation suggest: 0-5 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and >20 severe depression. The ninth item asks the participant to rate the frequency of the following: "Thoughts that you would be better off dead or of hurting yourself in some way" over the previous two weeks using a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day).
- Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in depression as measured by Patient Health Questionnaire - 9 Item (PHQ9) in the Pilot Trial. [6 months]
Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report inventory measures depressive symptoms. Derived from the validated full Patient Health Questionnaire, the PHQ-9 asks participants to rate frequency of their depressive symptoms over the previous two weeks using a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). Total scores (summing all items) range from 0-27. Guidelines for score interpretation suggest: 0-5 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and >20 severe depression.
- Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in suicidal ideation as measured by Patient Health Questionnaire - 9 Item (PHQ9) in the Pilot Trial. [6 months]
Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report inventory measures depressive symptoms. Derived from the validated full Patient Health Questionnaire, the PHQ-9 asks participants to rate frequency of their depressive symptoms over the previous two weeks using a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). Total scores (summing all items) range from 0-27. Guidelines for score interpretation suggest: 0-5 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and >20 severe depression. The ninth item asks the participant to rate the frequency of the following: "Thoughts that you would be better off dead or of hurting yourself in some way" over the previous two weeks using a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day).
- Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in generalized anxiety as measured by the Generalized Anxiety Disorder - 7 Item (GAD7) in the proof of concept project. [6 months]
The GAD-7 assesses generalized anxiety symptoms within a two week period. Participants rate how often they experienced various anxiety symptoms for seven items using a 4-point Likert scale: 0 (not at all) to 3 (nearly every day). Scores are summed (range 0-21), with 0-4 indicating minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.
- Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in generalized anxiety as measured by the Generalized Anxiety Disorder - 7 Item (GAD7) in the Pilot Trial [6 months]
The GAD-7 assesses generalized anxiety symptoms within a two week period. Participants rate how often they experienced various anxiety symptoms for seven items using a 4-point Likert scale: 0 (not at all) to 3 (nearly every day). Scores are summed (range 0-21), with 0-4 indicating minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.
- Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in death distress as measured by The Death and Dying Distress Scale (DADDS) in the proof of concept project. [6 months]
Death and Dying Distress Scale (DADDS). The DADDS is a validated measure of death anxiety in patients with advanced cancer. The 15-item scale includes items about distress related to the dying process, running out of time, and the impact of one's death on loved ones. The items are scored on a six-point Likert scale: 0 (not distressed) to 5 (extreme distress). Moderate death anxiety is defined by Death and Dying Distress Scale scores between 25 and 46, and severe death anxiety is defined as scores >47.
- Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in death distress as measured by The Death and Dying Distress Scale (DADDS) in the pilot trial. [6 months]
Death and Dying Distress Scale (DADDS).80 The DADDS is a validated measure of death anxiety in patients with advanced cancer.80 The 15-item scale includes items about distress related to the dying process, running out of time, and the impact of one's death on loved ones. The items are scored on a six-point Likert scale: 0 (not distressed) to 5 (extreme distress). Moderate death anxiety is defined by Death and Dying Distress Scale scores between 25 and 46, and severe death anxiety is defined as scores >47.
- Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in attachment as measured by Experiences in Close Relationships Inventory (ECR-M-16) in the proof of concept project. [6 months]
Experience in Close Relationships Inventory (ECR-M16). The ECR-M16 is a modified version of the 36- item ECR which has been validated for measuring attachment orientations to close others in patients with advanced cancer. It comprises 16 items in two subscales (attachment anxiety and avoidance). Respondents are asked to rate each item on a scale of 1-7: 1 (completely disagree) to 7 (completely agree).
- Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in attachment as measured by Experiences in Close Relationships Inventory (ECR-M-16) in the pilot trial [Post-randomization, 3, and 6 months after first assessment]
Experience in Close Relationships Inventory (ECR-M16). The ECR-M16 is a modified version of the 36- item ECR which has been validated for measuring attachment orientations to close others in patients with advanced cancer. It comprises 16 items in two subscales (attachment anxiety and avoidance). Respondents are asked to rate each item on a scale of 1-7: 1 (completely disagree) to 7 (completely agree).
- Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in posttraumatic stress as measured by the PTSD Checklist for DSM-5 (PCL-5) in the proof of concept project [6 months]
PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item assessment of PTSD symptoms which are concordant with the DSM-5 diagnostic items. Reponses are answered on a 5-point Likert scale (0 = Not at all, 1= A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely). Item scores are summed to yield a total score ranging from 0 to 80.
- Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in posttraumatic stress as measured by the PTSD Checklist for DSM-5 (PCL-5) in the pilot trial [6 months]
PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item assessment of PTSD symptoms which are concordant with the DSM-5 diagnostic items. Reponses are answered on a 5-point Likert scale (0 = Not at all, 1= A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely). Item scores are summed to yield a total score ranging from 0 to 80.
- Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in substance use as measured by the Tobacco, Alcohol, Prescription medication and other Substance Use (TAPS) in the proof of concept project. [6 months]
The TAPS tool includes a screener and a brief assessment. The TAPS-1 is a screener adapted from the National Institute on Drug Use quick screen with 4 items assessing frequency of use of tobacco, alcohol, prescription medication, and illicit substances (e.g., marijuana, cocaine).Any response other than "never" on the TAPS-1 indicates a positive screen, which leads to administration of the TAPS-2. The TAPS-2 is a brief assessment adapted from the Alcohol, Smoking, and Substance Involvement Screening Tool (ASSIST)-Lite104 including 3-4 yes/no questions for each class of substances assessing level of use, dependence, and concern from others. Cut-off for problematic substance use is 1+ and for substance use disorder is 2+.
- Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in substance use as measured by the Tobacco, Alcohol, Prescription medication and other Substance Use (TAPS) in the pilot trial [6 months]
The TAPS tool includes a screener and a brief assessment. The TAPS-1 is a screener adapted from the National Institute on Drug Use quick screen with 4 items assessing frequency of use of tobacco, alcohol, prescription medication, and illicit substances (e.g., marijuana, cocaine).Any response other than "never" on the TAPS-1 indicates a positive screen, which leads to administration of the TAPS-2. The TAPS-2 is a brief assessment adapted from the Alcohol, Smoking, and Substance Involvement Screening Tool (ASSIST)-Lite104 including 3-4 yes/no questions for each class of substances assessing level of use, dependence, and concern from others. Cut-off for problematic substance use is 1+ and for substance use disorder is 2+.
- Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in clinical evaluation as measured by the Clinical Evaluation Questionnaire (CEQ) in the proof of concept project. [6 months]
Clinical Evaluation Questionnaire (CEQ). The CEQ is a 7-item measure that was developed by the CALM team at Princess Margaret Cancer Centre to assess the extent to which individuals feel emotionally supported by clinical services in the domains relevant to CALM therapy. The CEQ refers to the patients' experience of CALM therapy.
- Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in clinical evaluation as measured by the Clinical Evaluation Questionnaire (CEQ) in the pilot trial [6 months]
Clinical Evaluation Questionnaire (CEQ). The CEQ is a 7-item measure that was developed by the CALM team at Princess Margaret Cancer Centre to assess the extent to which individuals feel emotionally supported by clinical services in the domains relevant to CALM therapy. For intervention participants, the CEQ refers to the patients' experience of CALM therapy. For TUC control participants, the CEQ refers to the patient's interactions with the health care team at their treating facility. The CEQ is assessed only at 3 and 6 months.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
At least 2 weeks post-surgical resection or biopsy (if applicable)
-
No evidence of major cognitive impairment
-
Report elevated depression (Patient Health Questionnaire-9 (PHQ-9) score ≥ 10) OR death anxiety symptoms (Death and Dying Distress Scale (DADDS) score ≥ 15)
-
Ability to read, speak, and understand English
-
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
-
Major communication difficulties, which would prohibit psychotherapeutic interaction
-
Inability to meet with interventionist via an electronic device for telehealth intervention sessions
-
Inability to understand and provide informed consent
-
Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant's risk
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
- United States Department of Defense
Investigators
- Principal Investigator: Ashlee Loughan, PhD, Virginia Commonwealth University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MCC-21-18040