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NCT06015932 | RECRUITING | Hematopoietic and Lymphoid System Neoplasm

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

Mayo Clinic

Information provided by (Responsible Party):

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

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.

Condition or disease

Hematopoietic and Lymphoid System Neoplasm

Malignant Solid Neoplasm

Metastatic Malignant Solid Neoplasm

Intervention/treatment

Cognitive Behavior Therapy

Questionnaire Administration

Phase

NA

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
Estimated Enrollment : 400 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : A Non-Randomized Translational Trial of Cognitive Behavioral Cancer Stress Management (CBCSM) and Its Effects on Cancer Distress
Actual Study Start Date : 2017-12-20
Estimated Primary Completion Date : 2029-12
Estimated Study Completion Date : 2029-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
Group Cognitive Behavior Sessions (CBCSM) to Decrease Distress in Cancer Patients

Location Details

NCT06015932

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How to Participate

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Locations

RECRUITING

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905