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Clinical Trials/NCT02070250
NCT02070250
Completed
Not Applicable

Examination of a Stress Management Intervention for Cancer Patients as Delivered by Community Mental Health Professionals

Ohio State University Comprehensive Cancer Center15 sites in 1 country158 target enrollmentNovember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mood
Sponsor
Ohio State University Comprehensive Cancer Center
Enrollment
158
Locations
15
Primary Endpoint
Change from baseline to post-intensive intervention assessment in cancer-specific stress on the 20-item Impact of Events Scale (IES)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Psychological interventions for cancer patients have been tested and found to reduce stress and improve quality of life. These interventions have been tested at academic medical centers but have not been available for use by community mental health professionals. One such intervention is the Biobehavioral Intervention (BBI), developed by Professor Barbara L. Andersen and colleagues at Ohio State (OSU). Current funding has enabled the investigators to train mental health professionals from across the country to deliver the BBI at their institution. Recently diagnosed cancer patients who are participating in the BBI group at these institutions may participate in a research study completing self report measures asking about psychological and behavioral outcomes (for example, mood, stress, diet and physical activity). The investigators hypothesize that individuals participating in the intervention will report improvements in outcomes, such as reduced stress and improved mood, reduced symptoms of the disease and treatment, etc., after completing the intervention and continue to report these improvements up to 6 months after the group ends. OSU will coordinate this data collection project but information about participating sites is listed in http://clinicaltrials.gov.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
September 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Barbara Andersen

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

Inclusion Criteria

  • Recent initial diagnosis of cancer without metastatic disease
  • Able to speak/read English

Exclusion Criteria

  • Those with concurrent diagnoses of
  • Organic brain syndrome
  • Mental retardation
  • non-English speaking
  • Significant sensory deficit
  • Severe mental illness (e.g., schizophrenia, psychotic disorder)

Outcomes

Primary Outcomes

Change from baseline to post-intensive intervention assessment in cancer-specific stress on the 20-item Impact of Events Scale (IES)

Time Frame: Baseline, up to 18 weeks

The intensive intervention length can vary by location from 4 to 18 weeks.

Change from baseline to post-intensive intervention assessment in mood on the 65-item Profile of Mood States (POMS)

Time Frame: Baseline, up to 18 weeks

The intensive intervention length can vary by location from 4 to 18 weeks.

Secondary Outcomes

  • Change from baseline to post-intensive intervention assessment in social support using the 20 item Perceived Social Support from Your Family Scale (PSS-Fa)(Baseline, up to 18 weeks)
  • Change from baseline to post-intensive intervention assessment in diet on the 23-item Food Habits Questionnaire (FHQ)(Baseline, up to 18 weeks)
  • Change from baseline to post-intensive intervention assessment in physical activity on the 3-item Physical Activity Rating Scale (PAR)(Baseline, up to 18 weeks)
  • Change from baseline to post-intensive intervention assessment in sexual health on the 4-item Your Sexual Life questionnaire(Baseline, up to 18 weeks)

Study Sites (15)

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