Group Cognitive Behavior Sessions (CBCSM) to Decrease Distress in Cancer Patients

A Non-Randomized Translational Trial of Cognitive Behavioral Cancer Stress Management (CBCSM) and Its Effects on Cancer Distress

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm; Metastatic Malignant Solid Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Cognitive Behavior Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
• Study Contact Backup: Name: Deanna Hofschulte; Phone Number: 507-255-2972; Email: Hofschulte.Deanna@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Contact: Deanna Hofschulte; Phone Number: 507-255-2972; Email: Hofschulte.Deanna@mayo.edu
      • Principal Investigator: Shawna L. Ehlers, Ph.D., L.P.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Questionnaire Administration; Complete questionnaires; Behavioral: Cognitive Behavior Therapy; Participate in CBCSM group sessions; Other Names: CT; CBT; cognitive therapy
Active Comparator: Group II (no CBCSM); Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.	Other: Questionnaire Administration; Complete questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline, 1, 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 12 months
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.	Baseline to 12 months
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.	At baseline, 1, 3, 6, and 12 months
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).	At baseline, 1, 3, 6, and 12 months
Anxiety	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, an 8-question survey. Seven questions are answered on a 0-3 scale where 0=Not at all and 3=Nearly every day. The final question is answered on a 4-point scale from Not Difficult at All to Extremely Difficult.	At baseline, 1, 3, 6, and 12 months
Depression	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-8 (PHQ-8). The PHQ-8 is an 8-item questionnaire answered on a scale of 0-3 where 0=Not at all and 3=Nearly every day.	At baseline, 1, 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Shawna L. Ehlers, Ph.D., L.P., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2017
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 17-000947 (Other Identifier: Mayo Clinic); NCI-2023-00250 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No