A Non-Randomized Translational Trial of Cognitive Behavioral Cancer Stress Management (CBCSM) and Its Effects on Cancer Distress
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hematopoietic and Lymphoid System Neoplasm
- Sponsor
- Mayo Clinic
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Change in post-traumatic stress (PTS) score
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
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.
Detailed Description
PRIMARY OBJECTIVE: I. To reduce psychological stress. SECONDARY OBJECTIVES: I. 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. IV. To estimate differences of conducting CBCSM virtually during the Public Health Emergency (PHE) versus in person pre-PHE. V. To estimate differences of conducting CBCSM post PHE virtually with limitation to Minnesota patients only. VI. To explore the difference using the same therapy in patients with advanced, metastatic disease in a individual setting versus patients without the advanced, metastatic disease in a group 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 and during follow-up at 1, 3, 6, and 12 months. GROUP II: Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.
Investigators
Shawna L. Ehlers, Ph.D., L.P.
Principal Investigator
Mayo Clinic
Eligibility 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)
Outcomes
Primary Outcomes
Change in post-traumatic stress (PTS) score
Time Frame: At baseline, 1, 3, 6, and 12 months
Each item on the PTS is rated on a 5-point scale (0=Not at all; 1=A little bit; 2=Moderately; 3=Quite a bit, and 4=Extremely). The total score can range from 0 to 36 with higher scores indicating greater severity of posttraumatic stress disorder.
Secondary Outcomes
- Change in post-traumatic growth (PTG) score(At baseline, 1, 3, 6, and 12 months)
- Change in self-efficacy score(At baseline, 1, 3, 6, and 12 months)
- Patient acceptability and satisfaction(Baseline to 12 months)
- Patient attendance and feasibility(Baseline to 12 months)
- Anxiety(At baseline, 1, 3, 6, and 12 months)
- Depression(At baseline, 1, 3, 6, and 12 months)