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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University Comprehensive Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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