Clinical trial NCT06015932: Group Cognitive Behavior Sessions (CBCSM) to Decrease Distress in Cancer Patients
Official title: A Non-Randomized Translational Trial of Cognitive Behavioral Cancer Stress Management (CBCSM) and Its Effects on Cancer Distress
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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)

Primary outcomes:
measure: Change in post-traumatic stress (PTS) score
timeFrame: At baseline, 1, 3, 6, and 12 months
Secondary outcomes:
measure: Change in post-traumatic growth (PTG) score
timeFrame: At baseline, 1, 3, 6, and 12 months
measure: Change in self-efficacy score
timeFrame: At baseline, 1, 3, 6, and 12 months
measure: Patient acceptability and satisfaction
timeFrame: Baseline to 12 months
measure: Patient attendance and feasibility
timeFrame: Baseline to 12 months
measure: Anxiety
timeFrame: At baseline, 1, 3, 6, and 12 months
measure: Depression
timeFrame: At baseline, 1, 3, 6, and 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Shawna L. Ehlers, Ph.D., L.P.
role: PRINCIPAL_INVESTIGATOR
References: