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

Malignant Solid Neoplasm Clinical Trial

Official title:

A Non-Randomized Translational Trial of Cognitive Behavioral Cancer Stress Management (CBCSM) and Its Effects on Cancer Distress

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06015932
• Other study ID #: 17-000947
• Secondary ID: NCI-2023-0025017
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2017
• Est. completion date: December 2029

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

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.

GROUP II: Patients complete questionnaires throughout the trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2029
• Est. primary completion date: December 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Behavioral:
• Cognitive Behavior Therapy
Participate in CBCSM group sessions

Other:
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in post-traumatic stress (PTS) score	Utilizing linear regression, intervention group membership (cognitive behavioral cancer stress management [Cognitive Behavioral Cancer Stress Management (CBCSM)] cases vs. control group) will be entered as the independent variable. PTS-change scores (post-intervention score - pre-intervention score) will be entered as the dependent variable. Covariates significantly associated with PTS score in univariate analyses and baseline PTS will be entered into the regression equation. P-values < .05 are significant.	At baseline, 1, 3, 6, and 12 months
Secondary	Change in post-traumatic growth (PTG) score	Will examine predicted reductions in PTG associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Scores will be measured using the Patient-Reported Outcomes Measurement System (PROMIS®)-Psychosocial Impact Scale-Positive .	At baseline, 1, 3, 6, and 12 months
Secondary	Change in self-efficacy score	Will examine predicted increase in self-efficacy associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Scores will be assessed using the Measure of Current Status-Part A (MOCS-A).	At baseline, 1, 3, 6, and 12 months
Secondary	Patient acceptability and satisfaction	Will be assessed by simple percentage, based on scores from an Institute for Healthcare Improvement 10-point Likert scale (0-10, "Would you recommend this program to your friends and family?" A score =7 indicates high individual satisfaction.	Baseline to 12 months
Secondary	Patient attendance and feasibility	Will be assessed by simple percentage. Attendance and feasibility will be determined by the number of patients attending =3 sessions out of five.	Baseline to 12 months
Secondary	Anxiety	Will examine predicted reductions in anxiety symptoms associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Anxiety will be measured using General Anxiety Disorder-7 (GAD-7) symptom scores.	At baseline, 1, 3, 6, and 12 months
Secondary	Depression	Will examine predicted reductions in depression symptoms associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Level of depression will be determined using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-8 (no suicidality item, item # 9) will be administered in research surveys in order to reduce need for clinical monitoring personnel. Note that all patients will have a suicidality assessment by a licensed mental health provider when care is initiated as standard of care as part of their evaluation in the Behavioral Medicine Program, and treatment will be recommended for all patients who meet clinical criteria for depression and/or suicidality. Follow-up care is continually available for all participants.	At baseline, 1, 3, 6, and 12 months

External Links

•   Mayo Clinic Clinical Trials