Anxiety DisorderNCT01764789
Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer
A study testing questionnaire administration, quality-of-life assessment and psychosocial assessment and care in people with Anxiety Disorder and Depression, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies stress reduction in improving quality of life in patients with recurrent gynecologic or breast cancer. Participating in a stress reduction program may help improve quality of life in patients with gynecologic or breast cancer. Read more about this study
- Who is it for?
- Ages 21 to 85 years, women only
- Conditions the study is for
- Anxiety Disorder, Depression, Fatigue
- What is being tested?
- questionnaire administration, quality-of-life assessment and psychosocial assessment and care
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jan 2012
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of recurrent breast or gynecologic cancer (any site) with any disease-free interval; second primary cancers do not meet this criterion
- English speaking
- Able and willing to give informed consent
- To be considered for the blood and saliva collection, women must fulfill the following secondary criteria:
- Diagnosis of recurrent breast or ovarian cancer with any disease-free interval
Who cannot join
- Residence > 70 miles from research site
- Subnormal intellectual potential (diagnosis of mental retardation)
- Progressive neurological or chronic, progressive, debilitating condition (e.g., dementia)
- Non-ambulatory
- Life expectancy less than 160 days, per the treating oncologist
- Current suicide risk sufficient to preclude treatment on an outpatient basis
- Chronic inflammatory or autoimmune disorder (e.g., rheumatoid arthritis, lupus)
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: A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence
This pilot clinical trial studies stress reduction in improving quality of life in patients with recurrent gynecologic or breast cancer. Participating in a stress reduction program may help improve quality of life in patients with gynecologic or breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To refine the intervention. II. Test the acceptability, feasibility, and clinical appropriateness of the intervention.
III. To provide a preliminary test of its efficacy.
OUTLINE:
Patients participate in a multi-component intervention based on cognitive and behavioral principles comprising mindfulness-based stress reduction (MBSR), an intervention to promote hopefulness, and a problem solving approach which navigates around obstacles or generates alternatives when goals become blocked. Additional topics may be covered as indicated by clinical need and patients goals. Biobehavioral components include addressing social and disease-specific quality of life, and pain education. Intensive treatment sessions continue weekly for 16 weeks followed by 2 biweekly and 2 monthly maintenance sessions.
After completion of study treatment, patients are followed up at 28 weeks.
- Conditions
- Anxiety Disorder, Depression, Fatigue, Leydig Cell Tumor, Ovarian Sarcoma, Ovarian Stromal Cancer
- Being tested
- questionnaire administration, quality-of-life assessment, psychosocial assessment and care, behavioral intervention, cognitive intervention
- Keywords
- psychological intervention, breast cancer, gynecologic cancer
- Medical subject headings
- Anxiety Disorders, Depression, Fatigue, Leydig Cell Tumor, Pain, Peritoneal Neoplasms, Pseudomyxoma Peritonei, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment, Ancillary studies
Patients will participate in a quality life assessment.
psychosocial assessment and careProcedure or surgery
Also called psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessment
Participate in multi-component biobehavioral intervention
behavioral interventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral Therapy
Participate in multi-component biobehavioral intervention
cognitive interventionOther
A multi-component intervention based on cognitive and behavioral principles will be used. It combines effective intervention strategies selected for their relevance to patients with recurrent cancer.
educational interventionOther
Also called intervention, educational
Participate in multi-component biobehavioral intervention
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (psychosocial intervention) | Experimental | Patients participate in a multi-component intervention based on cognitive and behavioral principles comprising MBSR, an intervention to promote hopefulness, and a problem solving approach which navigates around obstacles or generates alternatives when goals become blocked. Additional topics may be covered as indicated by clinical need and patients goals. Biobehavioral components include addressing social and disease-specific quality of life, and pain education. Intensive treatment sessions continue weekly for 16 weeks followed by 2 biweekly and 2 monthly maintenance sessions. Receives: Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: psychosocial assessment and care; Behavioral: behavioral intervention; Other: cognitive intervention; Other: educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life(QoL)
Quality of life as assessed by Short Form (SF)-36
Measured: up to 28 weeks
Secondary outcomes (7)
Mood as assessed by the Profile of Mood States (POMS)
Measured: Up to 28 weeks
Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D)
Measured: Up to 28 weeks
Stress as assessed by the Impact of Event Scale (IES)
Measured: Up to 28 weeks
Pain as assessed by the Brief Pain Inventory (BPI)
Measured: Up to 28 weeks
Fatigue as assessed by the Fatigue Severity Index (FSI)
Measured: Up to 28 weeks
Diurnal cortisol slope
Study participants will also collect saliva samples at home 4 times a day for 3 days. Saliva samples will be collected at the baseline, mid-treatment, post-treatment and 3-month follow-up assessments. These samples will be used to measure cortisol.
Measured: Up to 28 weeks
Inflammation
Blood samples will be used to measure levels of inflammatory markers. Blood draws will be coordinated with the participants' regularly scheduled blood draws to minimize discomfort.
Measured: Up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startOct 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies 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
- 39 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 Andersen, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764789
- Sponsor's protocol ID
- OSU-10026
- Other IDs
- NCI-2012-01177, R21CA135005
- Status last verified
- Oct 2015
- First submitted
- 8 Jan 2013
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence
- ClinicalTrials.gov ID
- NCT01764789
- Acronym / sponsor ID
- OSU-10026
- Conditions
- Anxiety Disorder, Depression, Fatigue, Leydig Cell Tumor, Ovarian Sarcoma, Ovarian Stromal Cancer
- Keywords
- psychological intervention, breast cancer, gynecologic cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Jan 2013 (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.
This pilot clinical trial studies stress reduction in improving quality of life in patients with recurrent gynecologic or breast cancer. Participating in a stress reduction program may help improve quality of life in patients with gynecologic or breast cancer.
Detailed description
PRIMARY OBJECTIVES:
- To refine the intervention. II. Test the acceptability, feasibility, and clinical appropriateness of the intervention.
III. To provide a preliminary test of its efficacy.
OUTLINE:
Patients participate in a multi-component intervention based on cognitive and behavioral principles comprising mindfulness-based stress reduction (MBSR), an intervention to promote hopefulness, and a problem solving approach which navigates around obstacles or generates alternatives when goals become blocked. Additional topics may be covered as indicated by clinical need and patients goals. Biobehavioral components include addressing social and disease-specific quality of life, and pain education. Intensive treatment sessions continue weekly for 16 weeks followed by 2 biweekly and 2 monthly maintenance sessions.
After completion of study treatment, patients are followed up at 28 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (psychosocial intervention) | Experimental | Other: questionnaire administration, Procedure: quality-of-life assessment, Procedure: psychosocial assessment and care, Behavioral: behavioral intervention, Other: cognitive intervention, Other: educational interventionPatients participate in a multi-component intervention based on cognitive and behavioral principles comprising MBSR, an intervention to promote hopefulness, and a problem solving approach which navigates around obstacles or generates alternatives when goals become blocked. Additional topics may be covered as indicated by clinical need and patients goals. Biobehavioral components include addressing social and disease-specific quality of life, and pain education. Intensive treatment sessions continue weekly for 16 weeks followed by 2 biweekly and 2 monthly maintenance sessions. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of recurrent breast or gynecologic cancer (any site) with any disease-free interval; second primary cancers do not meet this criterion
- English speaking
- Able and willing to give informed consent
- To be considered for the blood and saliva collection, women must fulfill the following secondary criteria:
Key exclusion criteria (7 listed)
- Residence > 70 miles from research site
- Subnormal intellectual potential (diagnosis of mental retardation)
- Progressive neurological or chronic, progressive, debilitating condition (e.g., dementia)
- Non-ambulatory
- Life expectancy less than 160 days, per the treating oncologist
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 |
|---|---|---|
| questionnaire administrationAncillary studies | Other | Supportive care (psychosocial intervention) |
| quality-of-life assessmentAlso: quality of life assessment, Ancillary studiesPatients will participate in a quality life assessment. | Procedure or surgery | Supportive care (psychosocial intervention) |
| psychosocial assessment and careAlso: psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessmentParticipate in multi-component biobehavioral intervention | Procedure or surgery | Supportive care (psychosocial intervention) |
| behavioral interventionAlso: Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral TherapyParticipate in multi-component biobehavioral intervention | Behavioural | Supportive care (psychosocial intervention) |
| cognitive interventionA multi-component intervention based on cognitive and behavioral principles will be used. It combines effective intervention strategies selected for their relevance to patients with recurrent cancer. | Other | Supportive care (psychosocial intervention) |
| educational interventionAlso: intervention, educationalParticipate in multi-component biobehavioral intervention | Other | Supportive care (psychosocial intervention) |
Primary outcome
Quality of life(QoL)
Time frame: up to 28 weeks
Quality of life as assessed by Short Form (SF)-36
7 secondary outcomes
Mood as assessed by the Profile of Mood States (POMS)
Time frame: Up to 28 weeks
Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D)
Time frame: Up to 28 weeks
Stress as assessed by the Impact of Event Scale (IES)
Time frame: Up to 28 weeks
Pain as assessed by the Brief Pain Inventory (BPI)
Time frame: Up to 28 weeks
Fatigue as assessed by the Fatigue Severity Index (FSI)
Time frame: Up to 28 weeks
Diurnal cortisol slope
Time frame: Up to 28 weeks
Inflammation
Time frame: Up to 28 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 9 Oct 2015.
- 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, PhD principal investigator
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 questionnaire administration, quality-of-life assessment and psychosocial assessment and care in people with Anxiety Disorder and Depression, 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 5 inclusion and 7 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 9 Oct 2015. 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?
Quality of life(QoL) (time frame: up to 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2015.