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Trial Title:
Group Cognitive Behavior Sessions (CBCSM) to Decrease Distress in Cancer Patients
NCT ID:
NCT06015932
Condition:
Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Cognitive Behavior Therapy
Description:
Participate in CBCSM group sessions
Arm group label:
Group I (CBCSM)
Other name:
CBT
Other name:
cognitive therapy
Other name:
CT
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Complete questionnaires
Arm group label:
Group I (CBCSM)
Arm group label:
Group II (no CBCSM)
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.
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Deanna Hofschulte
Phone:
507-255-2972
Email:
Hofschulte.Deanna@mayo.edu
Investigator:
Last name:
Shawna L. Ehlers, Ph.D., L.P.
Email:
Principal Investigator
Start date:
December 20, 2017
Completion date:
December 2029
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06015932
https://www.mayo.edu/research/clinical-trials
