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

Stress, Psychological Clinical Trial

— C2H-D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070250
• Other study ID #: OSU-13127
• Secondary ID: R25CA163197
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: September 2021

Study information

• Verified date: September 2021
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Mood
• Stress, Psychological

Intervention

Behavioral:
• From Cancer to Health (C2H-D)
From Cancer to Health gives people with cancer the information and tools they need to manage their stress to improve their health throughout the cancer journey. Each institution involved in this study will implement the core techniques of the C2H-D Intervention but may alter the format somewhat to meet their patient population needs (e.g., shorten hourly 18 week intervention into 2-hour 9 week intervention).

Locations

Country	Name	City	State
United States	Cancer Center of East Alabama Medical Center	Auburn	Alabama
United States	Seton UT Southwestern	Austin	Texas
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	OSU Stephanie Spielman Comprehensive Breast Center	Columbus	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Genesis Health Center	Davenport	Iowa
United States	Unity Point Health/Gilda's Club Quad Cities	Davenport	Iowa
United States	Wellness House	Hinsdale	Illinois
United States	University of Kentucky Markey Cancer Center	Lexington	Kentucky
United States	IU Health Ball Memorial Hospital	Muncie	Indiana
United States	Cancer Wellness Center	Northbrook	Illinois
United States	Baylor Regional Medical Center at Plano, Texas	Plano	Texas
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

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ashmore JA, Ditterich KW, Conley CC, Wright MR, Howland PS, Huggins KL, Cooreman J, Andrews PS, Nicholas DR, Roberts L, Hewitt L, Scales JN, Delap JK, Gray CA, Tyler LA, Collins C, Whiting CM, Brothers BM, Ryba MM, Andersen BL. Evaluating the effectiveness and implementation of evidence-based treatment: A multisite hybrid design. Am Psychol. 2019 May-Jun;74(4):459-473. doi: 10.1037/amp0000309. Epub 2018 Jul 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline to post-intensive intervention assessment in pain using the 13-item Brief Pain Questionnaire (BPQ)	The intensive intervention length can vary by location from 4 to 18 weeks.	Baseline, up to 18 weeks
Other	Change from baseline to post-intensive intervention assessment in fatigue using the 7-item Fatigue Severity Index (FSI)	The intensive intervention length can vary by location from 4 to 18 weeks.	Baseline, up to 18 weeks
Other	Change from baseline to post-intensive intervention assessment in sleep using the 24-item Pittsburgh Sleep Quality Index (PSQI)	The intensive intervention length can vary by location from 4 to 18 weeks.	Baseline, up to 18 weeks
Primary	Change from baseline to post-intensive intervention assessment in mood on the 65-item Profile of Mood States (POMS)	The intensive intervention length can vary by location from 4 to 18 weeks.	Baseline, up to 18 weeks
Primary	Change from baseline to post-intensive intervention assessment in cancer-specific stress on the 20-item Impact of Events Scale (IES)	The intensive intervention length can vary by location from 4 to 18 weeks.	Baseline, up to 18 weeks
Secondary	Change from baseline to post-intensive intervention assessment in social support using the 20 item Perceived Social Support from Your Family Scale (PSS-Fa)	The intensive intervention length can vary by location from 4 to 18 weeks.	Baseline, up to 18 weeks
Secondary	Change from baseline to post-intensive intervention assessment in physical activity on the 3-item Physical Activity Rating Scale (PAR)	The intensive intervention length can vary by location from 4 to 18 weeks.	Baseline, up to 18 weeks
Secondary	Change from baseline to post-intensive intervention assessment in diet on the 23-item Food Habits Questionnaire (FHQ)	The intensive intervention length can vary by location from 4 to 18 weeks.	Baseline, up to 18 weeks
Secondary	Change from baseline to post-intensive intervention assessment in sexual health on the 4-item Your Sexual Life questionnaire	The intensive intervention length can vary by location from 4 to 18 weeks.	Baseline, up to 18 weeks