Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT06015932
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2023-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Group Cognitive Behavior Sessions (CBCSM) to Decrease Distress in Cancer Patients
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
A Non-Randomized Translational Trial of Cognitive Behavioral Cancer Stress Management (CBCSM) and Its Effects on Cancer Distress
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: