Group Cognitive Behavior Sessions (CBCSM) to Decrease Distress in Cancer Patients
Study Details
Study Description
Brief Summary
This clinical trial tests how well cognitive behavioral cancer stress management (CBCSM) group sessions work to decrease psychological distress in cancer patients. CBCSM teaches patients how to recognize and reduce the impacts of cancer associated stress on the biological, psychological, and social life domains.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVE:
- To reduce psychological stress.
SECONDARY OBJECTIVES:
- To increase post-traumatic growth (PTG). II. To increase patient self-efficacy in utilizing therapy skills. III. To estimate patient acceptability and feasibility of conducting CBCSM within the clinical setting.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients participate in five CBCSM group sessions on study. Patients complete questionnaires throughout the trial.
GROUP II: Patients complete questionnaires throughout the trial.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group I (CBCSM) Patients participate in five CBCSM group sessions on study. Patients complete questionnaires throughout the trial. |
Behavioral: Cognitive Behavior Therapy
Participate in CBCSM group sessions
Other Names:
Other: Questionnaire Administration
Complete questionnaires
|
| Active Comparator: Group II (no CBCSM) Patients complete questionnaires throughout the trial. |
Other: Questionnaire Administration
Complete questionnaires
|
Outcome Measures
Primary Outcome Measures
- Change in post-traumatic stress (PTS) score [At baseline, 1, 3, 6, and 12 months]
Utilizing linear regression, intervention group membership (cognitive behavioral cancer stress management [Cognitive Behavioral Cancer Stress Management (CBCSM)] cases vs. control group) will be entered as the independent variable. PTS-change scores (post-intervention score - pre-intervention score) will be entered as the dependent variable. Covariates significantly associated with PTS score in univariate analyses and baseline PTS will be entered into the regression equation. P-values < .05 are significant.
Secondary Outcome Measures
- Change in post-traumatic growth (PTG) score [At baseline, 1, 3, 6, and 12 months]
Will examine predicted reductions in PTG associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Scores will be measured using the Patient-Reported Outcomes Measurement System (PROMIS®)-Psychosocial Impact Scale-Positive .
- Change in self-efficacy score [At baseline, 1, 3, 6, and 12 months]
Will examine predicted increase in self-efficacy associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Scores will be assessed using the Measure of Current Status-Part A (MOCS-A).
- Patient acceptability and satisfaction [Baseline to 12 months]
Will be assessed by simple percentage, based on scores from an Institute for Healthcare Improvement 10-point Likert scale (0-10, "Would you recommend this program to your friends and family?" A score ≥7 indicates high individual satisfaction.
- Patient attendance and feasibility [Baseline to 12 months]
Will be assessed by simple percentage. Attendance and feasibility will be determined by the number of patients attending ≥3 sessions out of five.
- Anxiety [At baseline, 1, 3, 6, and 12 months]
Will examine predicted reductions in anxiety symptoms associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Anxiety will be measured using General Anxiety Disorder-7 (GAD-7) symptom scores.
- Depression [At baseline, 1, 3, 6, and 12 months]
Will examine predicted reductions in depression symptoms associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Level of depression will be determined using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-8 (no suicidality item, item # 9) will be administered in research surveys in order to reduce need for clinical monitoring personnel. Note that all patients will have a suicidality assessment by a licensed mental health provider when care is initiated as standard of care as part of their evaluation in the Behavioral Medicine Program, and treatment will be recommended for all patients who meet clinical criteria for depression and/or suicidality. Follow-up care is continually available for all participants.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Eligible for the cognitive behavioral cancer stress management (CBCSM) clinical service
-
Cancer diagnosis with predicted survival > 1 year
-
Cancer treatment within past 1 year or treatment planning in progress
-
Age >= 18-years
-
Moderate distress screen, indicated by Impact of Event Scale-Revised (IES-R) score >= 14 or clinical judgment
-
Written informed research consent
Exclusion Criteria:
- Inability to actively participate in and learn from group therapy (e.g., psychotic symptoms, neurological condition, personality pathology) as determined by clinical judgment in clinical consultation (Individual therapy or alternative group therapy will be offered)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Shawna L. Ehlers, Ph.D., L.P., Mayo Clinic in Rochester
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 17-000947
- NCI-2023-00250
- 17-000947