MoodC2H-DNCT02070250
Stress Management for Cancer Patients: How Well Does it Work? (C2H-D)
A study testing From Cancer to Health (C2H-D) in people with Mood and Stress, Psychological, run by Ohio State University Comprehensive Cancer Center at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Mood, Stress, Psychological
- What is being tested?
- From Cancer to Health (C2H-D)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 15 sitesUnited States
- Study dates
- Nov 2013to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent initial diagnosis of cancer without metastatic disease
- Able to speak/read English
Who cannot join
- Organic brain syndrome
- Dementia
- Mental retardation
- non-English speaking
- Significant sensory deficit
- Severe mental illness (e.g., schizophrenia, psychotic disorder)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Cancer Center of East Alabama Medical Center
Auburn, Alabama, 36830
Seton UT Southwestern
Austin, Texas, 78705
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
OSU Stephanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43210
Geisinger Medical Center
Danville, Pennsylvania, 17822
Genesis Health Center
Davenport, Iowa, 52803
Unity Point Health/Gilda's Club Quad Cities
Davenport, Iowa, 52803
Wellness House
Hinsdale, Illinois, 60521
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536
IU Health Ball Memorial Hospital
Muncie, Indiana, 47303
Cancer Wellness Center
Northbrook, Illinois, 60062
Baylor Regional Medical Center at Plano, Texas
Plano, Texas, 75093
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
Providence Saint John's Health Center
Santa Monica, California, 90404
Tahoe Forest Cancer Center
Truckee, California, 96161
About this study
Official title: 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.
- Conditions
- Mood, Stress, Psychological
- Being tested
- From Cancer to Health (C2H-D)
- Keywords
- Stress management, Coping skills, Recently diagnosed cancer patients, Intervention, Psychological
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
From Cancer to Health (C2H-D)Behavioural
Also called C2H, Biobehavioral Intervention, BBI, Stress management
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).
| Study group | Role | What they receive |
|---|---|---|
| From Cancer to Health (C2H-D) | Experimental | Individuals participating in the From Cancer to Health (C2H-D) Stress Management Psychological Intervention Receives: Behavioral: From Cancer to Health (C2H-D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The intensive intervention length can vary by location from 4 to 18 weeks.
Measured: Baseline, up to 18 weeks
Secondary outcomes (4)
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.
Measured: 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)
The intensive intervention length can vary by location from 4 to 18 weeks.
Measured: Baseline, up 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.
Measured: Baseline, up 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.
Measured: Baseline, up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionSep 2021
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MoodStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Barbara Andersen, Ohio State University Comprehensive Cancer Center
- Investigators
- Barbara L Andersen, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070250
- Sponsor's protocol ID
- OSU-13127
- Other IDs
- R25CA163197
- Acronym
- C2H-D
- Status last verified
- Sep 2021
- First submitted
- 20 Feb 2014
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30024215
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of a Stress Management Intervention for Cancer Patients as Delivered by Community Mental Health Professionals
- ClinicalTrials.gov ID
- NCT02070250
- Acronym / sponsor ID
- C2H-D / OSU-13127
- Conditions
- Mood, Stress, Psychological
- Keywords
- Stress management, Coping skills, Recently diagnosed cancer patients, Intervention, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2013
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| From Cancer to Health (C2H-D) | Experimental | Behavioral: From Cancer to Health (C2H-D)Individuals participating in the From Cancer to Health (C2H-D) Stress Management Psychological Intervention |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recent initial diagnosis of cancer without metastatic disease
- Able to speak/read English
Key exclusion criteria (6 listed)
- Organic brain syndrome
- Dementia
- Mental retardation
- non-English speaking
- Significant sensory deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| From Cancer to Health (C2H-D)Also: C2H, Biobehavioral Intervention, BBI, Stress managementFrom 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). | Behavioural | From Cancer to Health (C2H-D) |
Primary outcome
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.
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.
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Background: PubMed 30024215Ashmore 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara L Andersen, PhD principal investigator
Ohio State University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing From Cancer to Health (C2H-D) in people with Mood and Stress, Psychological, run by Ohio State University Comprehensive Cancer Center at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02070250, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.