Clinical trial · Interventional
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
NCT06015932CI-TRIAL-00114050recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ALIAS | 0.90 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Metastatic Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavior Therapy | Behavioral | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (CBCSM)
- description
- 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.
- interventionNames
- Behavioral: Cognitive Behavior Therapy
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Group II (no CBCSM)
- description
- Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.
- interventionNames
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Change in post-traumatic stress (PTS) score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.