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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Andersen, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02070250
First received: February 20, 2014
Last updated: July 13, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
Mood
Stress, Psychological
Behavioral: From Cancer to Health (C2H-D)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Examination of a Stress Management Intervention for Cancer Patients as Delivered by Community Mental Health Professionals

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The intensive intervention length can vary by location from 4 to 18 weeks.

  • 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 ] [ Designated as safety issue: No ]
    The intensive intervention length can vary by location from 4 to 18 weeks.


Secondary Outcome Measures:
  • Change from baseline to post-intensive intervention assessment in social support using the 20 item Perceived Social Support from Your Family Scale (PSS-Fa) [ Time Frame: Baseline, up to 18 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, up to 18 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, up to 18 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, up to 18 weeks ] [ Designated as safety issue: No ]
    The intensive intervention length can vary by location from 4 to 18 weeks.


Other Outcome Measures:
  • Change from baseline to post-intensive intervention assessment in pain using the 13-item Brief Pain Questionnaire (BPQ) [ Time Frame: Baseline, up to 18 weeks ] [ Designated as safety issue: No ]
    The intensive intervention length can vary by location from 4 to 18 weeks.

  • Change from baseline to post-intensive intervention assessment in fatigue using the 7-item Fatigue Severity Index (FSI) [ Time Frame: Baseline, up to 18 weeks ] [ Designated as safety issue: No ]
    The intensive intervention length can vary by location from 4 to 18 weeks.

  • Change from baseline to post-intensive intervention assessment in sleep using the 24-item Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, up to 18 weeks ] [ Designated as safety issue: No ]
    The intensive intervention length can vary by location from 4 to 18 weeks.


Estimated Enrollment: 120
Study Start Date: November 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: From Cancer to Health (C2H-D)
Individuals participating in the From Cancer to Health (C2H-D) Stress Management 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).
Other Names:
  • C2H
  • Biobehavioral Intervention
  • BBI
  • Stress management

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Dementia
  • Mental retardation
  • non-English speaking
  • Significant sensory deficit
  • Severe mental illness (e.g., schizophrenia, psychotic disorder)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02070250

Locations
United States, Alabama
Cancer Center of East Alabama Medical Center
Auburn, Alabama, United States, 36830
United States, California
Tahoe Forest Cancer Center
Truckee, California, United States, 96161
United States, Illinois
Cancer Wellness Center
Northbrook, Illinois, United States, 60062
United States, Indiana
IU Health Ball Memorial Hospital
Muncie, Indiana, United States, 47303
United States, Ohio
OSU Stephanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States, 43210
United States, Texas
Seton UT Southwestern
Austin, Texas, United States, 78705
Baylor Regional Medical Center at Plano, Texas
Plano, Texas, United States, 75093
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Barbara L Andersen, PhD Ohio State University
  More Information

Additional Information:
Responsible Party: Barbara Andersen, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02070250     History of Changes
Other Study ID Numbers: OSU-13127  R25CA163197 
Study First Received: February 20, 2014
Last Updated: July 13, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Stress management
Coping skills
Recently diagnosed cancer patients
Intervention, Psychological

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 26, 2016