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

NCT ID: NCT02070250

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2021-09-30

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.

Conditions

Mood; Stress, Psychological

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

From Cancer to Health (C2H-D)

Individuals participating in the From Cancer to Health (C2H-D) Stress Management Psychological Intervention

Group Type: EXPERIMENTAL

From Cancer to Health (C2H-D)

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

C2H; Biobehavioral Intervention; BBI; Stress management

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Barbara Andersen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara L Andersen, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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

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

Seton UT Southwestern

Austin, Texas, United States

Baylor Regional Medical Center at Plano, Texas

Plano, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30024215 (View on PubMed)

Other Identifiers

R25CA163197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OSU-13127

Identifier Type: -

Identifier Source: org_study_id