Recruiting

CBCSM

Sponsor:

Mayo Clinic

Code:

NCT06015932

Conditions

Hematopoietic and Lymphoid System Neoplasm

Malignant Solid Neoplasm

Metastatic Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavior Therapy

Questionnaire Administration

Study Details

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.

Conditions

Hematopoietic and Lymphoid System Neoplasm

Malignant Solid Neoplasm

Metastatic Malignant Solid Neoplasm

Study ID

NCT06015932

Start date

Dec 20, 2017

Status verified date

Jun, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group I (CBCSM)

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.

active comparator: Group II (no CBCSM)

Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.

Interventions

Cognitive Behavior Therapy

Participate in CBCSM group sessions

Questionnaire Administration

Complete questionnaires

Primary outcome measure

  • Change in post-traumatic stress (PTS) score [ Time Frame: At baseline, 1, 3, 6, and 12 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Deanna Hofschulte

507-255-2972Hofschulte.Deanna@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Deanna Hofschulte

507-255-2972Hofschulte.Deanna@mayo.edu

Principal Investigator:

Shawna L. Ehlers, Ph.D., L.P.

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-09.