Stress Management for Cancer Patients: How Well Does it Work? (C2H-D)

Not Applicable

Completed

• Conditions: Mood; Stress, Psychological

• Registration Number: NCT02070250
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-02-20
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-25
• Status Verified: 2021-09
• Primary Completion: 2021-09
• Study Completion: 2021-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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
• Dementia
• Mental retardation
• non-English speaking
• Significant sensory deficit
• Severe mental illness (e.g., schizophrenia, psychotic disorder)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline to post-intensive intervention assessment in cancer-specific stress on the 20-item Impact of Events Scale (IES)	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)	Baseline, up to 18 weeks	The intensive intervention length can vary by location from 4 to 18 weeks.

Secondary Outcome Measures

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

Trial Locations

Locations (15)

Cancer Center of East Alabama Medical Center; 🇺🇸 Auburn, Alabama, United States

UC Davis Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States

Providence Saint John's Health Center; 🇺🇸 Santa Monica, California, United States

Tahoe Forest Cancer Center; 🇺🇸 Truckee, California, United States

Wellness House; 🇺🇸 Hinsdale, Illinois, United States

Cancer Wellness Center; 🇺🇸 Northbrook, Illinois, United States

IU Health Ball Memorial Hospital; 🇺🇸 Muncie, Indiana, United States

Genesis Health Center; 🇺🇸 Davenport, Iowa, United States

Unity Point Health/Gilda's Club Quad Cities; 🇺🇸 Davenport, Iowa, United States

University of Kentucky Markey Cancer Center; 🇺🇸 Lexington, Kentucky, United States

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