Breast Cancer Stage IINCT03578627
Stress and Immunity Breast Cancer Project
A study testing BioBehavioral Intervention in people with Breast Cancer Stage II and Breast Cancer Stage III, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
An investigative study of the effectiveness of the BioBehavioral Intervention on Stage II/III breast cancer patients. A total of 231 patients were split between an assessment-only control group and an experimental group receiving the Intervention and assessment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Stage II, Breast Cancer Stage III
- What is being tested?
- BioBehavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 1994to 31 May 2000
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage II or III breast cancer diagnosis prior to adjuvant therapy
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Psychological/Immunity Studies With Women With Cancer Previously
An investigative study of the effectiveness of the BioBehavioral Intervention on Stage II/III breast cancer patients. A total of 231 patients were split between an assessment-only control group and an experimental group receiving the Intervention and assessment. The goal of the Intervention is to use psychological, behavioral, and biologic methods with the primary goal of reducing cancer recurrence.
- Conditions
- Breast Cancer Stage II, Breast Cancer Stage III
- Being tested
- BioBehavioral Intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioBehavioral InterventionBehavioural
Psychological (stress and quality of life), behavioral (health behaviors and compliance), and biologic (neuroendocrine and immune) factors, and pathways by which health outcomes (e.g. disease endpoints-recurrence, disease free interval) might be affected.
| Study group | Role | What they receive |
|---|---|---|
| Assessment-only | No intervention | Not described |
| Intervention | Experimental | Not described Receives: Behavioral: BioBehavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence event
Diagnosis of pathologically confirmed breast cancer recurrence
Measured: Ten years
Recurrence time
Time from the day of initial stage II or III breast cancer diagnosis to day of pathology confirmed breast cancer recurrence
Measured: Ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 May 1994
- Primary completion31 May 2000
- Study completion31 May 2000
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 Breast Cancer Stage IIStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Andersen, Ohio State University Comprehensive Cancer Center
- Investigators
- Barbara Andersen, Principal investigator, The Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578627
- Sponsor's protocol ID
- 1992C0350
- Status last verified
- Jul 2018
- First submitted
- 19 Jun 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Conley CC, Andersen BL. Lemons to lemonade: Effects of a biobehavioral intervention for cancer patients on later life changes. Health Psychol. 2019 Mar;38(3):206-216. doi: 10.1037/hea0000717.
PubMed 30762400
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological/Immunity Studies With Women With Cancer Previously
- ClinicalTrials.gov ID
- NCT03578627
- Acronym / sponsor ID
- 1992C0350
- Conditions
- Breast Cancer Stage II, Breast Cancer Stage III
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 May 1994 (actual)
- Primary completion
- 31 May 2000 (actual)
- Study completion
- 31 May 2000 (actual)
- First posted
- 6 Jul 2018 (actual)
- 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.
An investigative study of the effectiveness of the BioBehavioral Intervention on Stage II/III breast cancer patients. A total of 231 patients were split between an assessment-only control group and an experimental group receiving the Intervention and assessment. The goal of the Intervention is to use psychological, behavioral, and biologic methods with the primary goal of reducing cancer recurrence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assessment-only | No intervention | – |
| Intervention | Experimental | Behavioral: BioBehavioral Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stage II or III breast cancer diagnosis prior to adjuvant therapy
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| BioBehavioral InterventionPsychological (stress and quality of life), behavioral (health behaviors and compliance), and biologic (neuroendocrine and immune) factors, and pathways by which health outcomes (e.g. disease endpoints-recurrence, disease free interval) might be affected. | Behavioural | Intervention |
Primary outcome
Recurrence event
Time frame: Ten years
Diagnosis of pathologically confirmed breast cancer recurrence
Recurrence time
Time frame: Ten years
Time from the day of initial stage II or III breast cancer diagnosis to day of pathology confirmed breast cancer recurrence
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 6 Jul 2018.
- Derived from this study: PubMed 30762400Conley CC, Andersen BL. Lemons to lemonade: Effects of a biobehavioral intervention for cancer patients on later life changes. Health Psychol. 2019 Mar;38(3):206-216. doi: 10.1037/hea0000717.
- The JameslineLink provided by the sponsor.
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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 Andersen principal investigator
The Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioBehavioral Intervention in people with Breast Cancer Stage II and Breast Cancer Stage III, run by Ohio State University Comprehensive Cancer Center at 1 site 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 1 inclusion and 1 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 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Recurrence event (time frame: Ten years). 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 NCT03578627, 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 6 Jul 2018.