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

September 10, 2021 updated by: Barbara Andersen, Ohio State University Comprehensive Cancer Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Auburn, Alabama, United States, 36830
        • Cancer Center of East Alabama Medical Center
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Comprehensive Cancer Center
      • Santa Monica, California, United States, 90404
        • Providence Saint John's Health Center
      • Truckee, California, United States, 96161
        • Tahoe Forest Cancer Center
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Wellness House
      • Northbrook, Illinois, United States, 60062
        • Cancer Wellness Center
    • Indiana
      • Muncie, Indiana, United States, 47303
        • IU Health Ball Memorial Hospital
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Genesis Health Center
      • Davenport, Iowa, United States, 52803
        • Unity Point Health/Gilda's Club Quad Cities
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Markey Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Ohio
      • Columbus, Ohio, United States, 43210
        • OSU Stephanie Spielman Comprehensive Breast Center
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
    • Texas
      • Austin, Texas, United States, 78705
        • Seton UT Southwestern
      • Plano, Texas, United States, 75093
        • Baylor Regional Medical Center at Plano, Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Stress management
  • C2H
  • Biobehavioral Intervention
  • BBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, up 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
The intensive intervention length can vary by location from 4 to 18 weeks.
Baseline, up to 18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The intensive intervention length can vary by location from 4 to 18 weeks.
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)
Time Frame: Baseline, up to 18 weeks
The intensive intervention length can vary by location from 4 to 18 weeks.
Baseline, up 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
The intensive intervention length can vary by location from 4 to 18 weeks.
Baseline, up 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
The intensive intervention length can vary by location from 4 to 18 weeks.
Baseline, up to 18 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The intensive intervention length can vary by location from 4 to 18 weeks.
Baseline, up 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
The intensive intervention length can vary by location from 4 to 18 weeks.
Baseline, up 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
The intensive intervention length can vary by location from 4 to 18 weeks.
Baseline, up to 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Barbara L Andersen, PhD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

February 20, 2014

First Submitted That Met QC Criteria

February 24, 2014

First Posted (Estimate)

February 25, 2014

Study Record Updates

Last Update Posted (Actual)

September 17, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-13127
  • R25CA163197 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress, Psychological

Clinical Trials on From Cancer to Health (C2H-D)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe