Stress Management for Cancer Patients: How Well Does it Work? (C2H-D) (C2H-D)
Primary Purpose
Mood, Stress, Psychological
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
From Cancer to Health (C2H-D)
Sponsored by
About this trial
This is an interventional supportive care trial for Mood focused on measuring Stress management, Coping skills, Recently diagnosed cancer patients, Intervention, Psychological
Eligibility 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)
Sites / Locations
- Cancer Center of East Alabama Medical Center
- UC Davis Comprehensive Cancer Center
- Providence Saint John's Health Center
- Tahoe Forest Cancer Center
- Wellness House
- Cancer Wellness Center
- IU Health Ball Memorial Hospital
- Genesis Health Center
- Unity Point Health/Gilda's Club Quad Cities
- University of Kentucky Markey Cancer Center
- Dana-Farber Cancer Institute
- OSU Stephanie Spielman Comprehensive Breast Center
- Geisinger Medical Center
- Seton UT Southwestern
- Baylor Regional Medical Center at Plano, Texas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
From Cancer to Health (C2H-D)
Arm Description
Individuals participating in the From Cancer to Health (C2H-D) Stress Management Psychological Intervention
Outcomes
Primary Outcome Measures
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.
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.
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)
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)
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)
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
The intensive intervention length can vary by location from 4 to 18 weeks.
Full Information
NCT ID
NCT02070250
First Posted
February 20, 2014
Last Updated
September 10, 2021
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02070250
Brief Title
Stress Management for Cancer Patients: How Well Does it Work? (C2H-D)
Acronym
C2H-D
Official Title
Examination of a Stress Management Intervention for Cancer Patients as Delivered by Community Mental Health Professionals
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2021 (Actual)
Study Completion Date
September 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood, Stress, Psychological
Keywords
Stress management, Coping skills, Recently diagnosed cancer patients, Intervention, Psychological
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
From Cancer to Health (C2H-D)
Arm Type
Experimental
Arm Description
Individuals participating in the From Cancer to Health (C2H-D) Stress Management Psychological Intervention
Intervention Type
Behavioral
Intervention Name(s)
From Cancer to Health (C2H-D)
Other Intervention Name(s)
C2H, Biobehavioral Intervention, BBI, Stress management
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from baseline to post-intensive intervention assessment in mood on the 65-item Profile of Mood States (POMS)
Description
The intensive intervention length can vary by location from 4 to 18 weeks.
Time Frame
Baseline, up to 18 weeks
Title
Change from baseline to post-intensive intervention assessment in cancer-specific stress on the 20-item Impact of Events Scale (IES)
Description
The intensive intervention length can vary by location from 4 to 18 weeks.
Time Frame
Baseline, up to 18 weeks
Secondary Outcome Measure Information:
Title
Change from baseline to post-intensive intervention assessment in social support using the 20 item Perceived Social Support from Your Family Scale (PSS-Fa)
Description
The intensive intervention length can vary by location from 4 to 18 weeks.
Time Frame
Baseline, up to 18 weeks
Title
Change from baseline to post-intensive intervention assessment in physical activity on the 3-item Physical Activity Rating Scale (PAR)
Description
The intensive intervention length can vary by location from 4 to 18 weeks.
Time Frame
Baseline, up to 18 weeks
Title
Change from baseline to post-intensive intervention assessment in diet on the 23-item Food Habits Questionnaire (FHQ)
Description
The intensive intervention length can vary by location from 4 to 18 weeks.
Time Frame
Baseline, up to 18 weeks
Title
Change from baseline to post-intensive intervention assessment in sexual health on the 4-item Your Sexual Life questionnaire
Description
The intensive intervention length can vary by location from 4 to 18 weeks.
Time Frame
Baseline, up to 18 weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline to post-intensive intervention assessment in pain using the 13-item Brief Pain Questionnaire (BPQ)
Description
The intensive intervention length can vary by location from 4 to 18 weeks.
Time Frame
Baseline, up to 18 weeks
Title
Change from baseline to post-intensive intervention assessment in fatigue using the 7-item Fatigue Severity Index (FSI)
Description
The intensive intervention length can vary by location from 4 to 18 weeks.
Time Frame
Baseline, up to 18 weeks
Title
Change from baseline to post-intensive intervention assessment in sleep using the 24-item Pittsburgh Sleep Quality Index (PSQI)
Description
The intensive intervention length can vary by location from 4 to 18 weeks.
Time Frame
Baseline, up to 18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara L Andersen, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center of East Alabama Medical Center
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36830
Country
United States
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Providence Saint John's Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Tahoe Forest Cancer Center
City
Truckee
State/Province
California
ZIP/Postal Code
96161
Country
United States
Facility Name
Wellness House
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Cancer Wellness Center
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
IU Health Ball Memorial Hospital
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
Genesis Health Center
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Unity Point Health/Gilda's Club Quad Cities
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
University of Kentucky Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
OSU Stephanie Spielman Comprehensive Breast Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Seton UT Southwestern
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Baylor Regional Medical Center at Plano, Texas
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30024215
Citation
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.
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Stress Management for Cancer Patients: How Well Does it Work? (C2H-D)
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