Menu
Recruiting NCT06015932

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

No phase Interventional Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive Behavior Therapy, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Cognitive Behavior Therapy
    Participate in CBCSM group sessions
  • Other Questionnaire Administration
    Complete questionnaires

Primary outcome measures

  • Change in post-traumatic stress (PTS) score [Time frame: At baseline, 1, 3, 6, and 12 months]
Secondary outcome measures (6)
  • Change in post-traumatic growth (PTG) score [Time frame: At baseline, 1, 3, 6, and 12 months]
  • Change in self-efficacy score [Time frame: At baseline, 1, 3, 6, and 12 months]
  • Patient acceptability and satisfaction [Time frame: Baseline to 12 months]
  • Patient attendance and feasibility [Time frame: Baseline to 12 months]
  • Anxiety [Time frame: At baseline, 1, 3, 6, and 12 months]
  • Depression [Time frame: At baseline, 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06015932 · 17-000947

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗