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

Mayo Clinic

Status: Enrolling

Conditions: Metastatic Malignant Solid Neoplasm; Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm

Treatments: Other: Questionnaire Administration; Behavioral: Cognitive Behavior Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06015932

NCI-2023-00250 (Registry Identifier)

17-000947 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Group I (CBCSM)

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavior Therapy

Other: Questionnaire Administration

Group II (no CBCSM)

Active Comparator group

Description:

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

Treatment:

Other: Questionnaire Administration