Group sessions to help cancer patients manage stress
A Non-Randomized Translational Trial of Cognitive Behavioral Cancer Stress Management (CBCSM) and Its Effects on Cancer Distress
This study is testing if group sessions that teach cancer patients how to manage stress can help them feel better mentally and cope with their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06015932 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of cognitive behavioral cancer stress management (CBCSM) group sessions in reducing psychological distress among cancer patients. Participants will be assigned to either a group receiving CBCSM or a control group, with both groups completing questionnaires at various follow-up intervals. The study aims to enhance post-traumatic growth, improve self-efficacy in therapy skills, and assess the feasibility of CBCSM in clinical settings, including virtual formats. It also explores differences in outcomes based on disease stage and treatment settings.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a cancer diagnosis and moderate distress who are eligible for CBCSM services.
Not a fit: Patients with severe psychological conditions that prevent participation in group therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce psychological distress and improve quality of life for cancer patients.
How similar studies have performed: Previous studies have shown that cognitive behavioral therapies can effectively reduce distress in cancer patients, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Shawna L. Ehlers, Ph.D., L.P. — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.