Trials / Recruiting
RecruitingNCT06015932
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Hematopoietic and Lymphoid System Neoplasm
- Malignant Solid Neoplasm
- Metastatic Malignant Solid Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Cognitive Behavior Therapy | Participate in CBCSM group sessions |
| OTHER | Questionnaire Administration | Complete questionnaires |
Timeline
- Start date
- 2017-12-20
- Primary completion
- 2029-12-01
- Completion
- 2029-12-01
- First posted
- 2023-08-29
- Last updated
- 2025-07-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06015932. Inclusion in this directory is not an endorsement.