About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Cognitive Behavior Therapy
BehavioralParticipate in CBCSM group sessions
Questionnaire Administration
Other interventionComplete questionnaires
Treatment groups
Trial outcomes
Primary outcomes
Change in post-traumatic stress (PTS) score
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
PTG will be assessed using the Patient-Reported Outcomes Measurement System (PROMIS®)-Psychosocial Impact Scale-Positive. The PROMIS assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain.
Change in self-efficacy score
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), which measures participants' current self-perceived status on several skills: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, express anger effectively and appropriately, and choose appropriate coping responses as needed. Ratings are made on a scale from I cannot do this at all (0) to I can do this extremely well (4).
Patient acceptability and satisfaction
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
Will be assessed by simple percentage. Attendance and feasibility will be determined by the number of patients attending ≥3 sessions out of five.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.