Current status and perspectives of psychological & behavioral interventional clinical trials (PBCTs) for cancer-related distress: A systematic scoping review of ClinicalTrials.gov.

BACKGROUND

Cancer is one of the chronic diseases that has a debilitating effect on the mental health of patients as well as their caregivers. Psychological and behavioral interventions are used to alleviate distress symptoms. The present study aimed to review registered clinical trials on psychological and behavioral interventions used to treat cancer-related distress.

METHODS

The current study employs the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for guideline. All interventional clinical trials registered at ClinicalTrials.gov for cancer-related distress were searched as of March 31, 2025. Boolean operators "AND/OR" were used to refine the search. The initial search yielded 341 results, which were reduced to 83 by applying a methodological filter, and only 36 trials fulfilled the inclusion criteria. Only registered trials that use psychological and behavioral interventions to alleviate cancer distress conducted with the adult population were included in the study.

RESULTS

As of September 30, 2025, 36 clinical trials in the ClinicalTrials.gov registry fulfilled inclusion criteria. All registered trials were analyzed qualitatively and quantitatively. Of 36 trials, almost 63.9% have been completed. 75% of studies utilize parallel randomized trials, where 50% of registered trials use Open-label masking. 27.8% of trials utilize the psychoeducational approach to deal cancer-related distress. 61.1% interventions were delivered individually within a clinical setting (66.7%). Moreover, the study identified 6 themes: managing distress, using innovative techniques, personalized care, culturally sensitive approaches, integrated care, and optimizing healing mechanisms.

CONCLUSION

The progress of inclusive and flexible therapies must continue to advance if psychosocial support is to be completely incorporated into cancer treatment. Patients' overall well-being can be improved by increasing accessibility and efficacy through interdisciplinary teamwork and culturally sensitive techniques. The findings support improving the psychological well-being of cancer patients and caregivers through policy reforms and research priorities.