Examination of a Stress Management Intervention for Cancer Patients as Delivered by Community Mental Health Professionals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- 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)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
From Cancer to Health (C2H-D)
Individuals participating in the From Cancer to Health (C2H-D) Stress Management Psychological Intervention
Intervention: From Cancer to Health (C2H-D) (Behavioral)
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)
Investigators
Barbara Andersen
Principal Investigator
Ohio State University Comprehensive Cancer Center