NeoplasmsPhase 2NCT02454036
Biobehavioral Intervention in Gynecologic Oncology Patients
A Phase 2 study testing BBI intervention in people with Neoplasms and Ovarian Neoplasms, run by Rachel Miller at 1 site in United States.
Trial summary
Baseline self-report outcome measures will be completed and additional assessments will occur mid-treatment , post-treatment , 3 months following completion of all sessions, and 6 months following completion of all sessions. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Neoplasms, Ovarian Neoplasms, Uterine Neoplasms
- What is being tested?
- BBI intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 18 May 2017
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females
- Stage I-IV gynecologic cancer (including ovarian, uterine, cervical, vulvar, or vaginal cancer)
- Undergoing active treatment or in remission and undergoing active surveillance; age ≥21 and ≤80
- Able to speak/read English.
Who cannot join
- Concurrent diagnosis of organic brain syndrome, dementia, mental retardation
- Non-English speaking, or significant sensory deficit
- Major mental illness (e.g., schizophrenia, psychotic disorder).
Trial locations and contacts
1 site in 1 country.
United States1 site
Markey Cancer Center, University of Kentucky
Lexington, Kentucky, 40536
About this study
Official title: Psychological Changes in Cancer Patients Receiving a Biobehavioral Intervention: A Program Evaluation
Baseline self-report outcome measures will be completed and additional assessments will occur mid-treatment , post-treatment , 3 months following completion of all sessions, and 6 months following completion of all sessions. Patients and therapists will complete the evaluation measures in private (at home, in an office).
At the University of Kentucky Markey Cancer Center, BBI treatment is offered in group and individual formats. The course of individual treatment varies and group treatment consists of 10 1.5-hour weekly sessions in the "intensive" phase, followed by 2 1.5-hour bi-weekly maintenance sessions. Individual treatment is one-on-one. In group treatment, there are typically 6-12 patients per group and 1 or 2 therapists. The intervention helps patients to learn adaptive coping strategies and how to apply them to daily stressors. Additional content discusses use of seeking information, enhancing social support, enhancing body esteem and intimacy, and maintaining positive changes.
- Conditions
- Neoplasms, Ovarian Neoplasms, Uterine Neoplasms, Vulva
- Being tested
- BBI intervention
- Medical subject headings
- Neoplasms, Ovarian Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBI interventionBehavioural
Also called Biobehavioral Intervention
Psychological intervention designed to reduce stress and enhance quality of life
| Study group | Role | What they receive |
|---|---|---|
| BBI Intervention | Experimental | Biobehavioral Intervention Receives: Behavioral: BBI intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional distress as measured by Profile of Mood States score
Measured: Up to 6 months following completion of treatment
Cancer specific traumatic stress as measured the by Impact of Events Scale score
Measured: Up to 6 months following completion of treatment
Social support as measured by the Perceived Social Support from Family score
Measured: Up to 6 months following completion of treatment
Physical activity as measured by the Godin-Shepard Leisure-Time Physical Activity Questionnaire score
Measured: Up to 6 months following completion of treatment
Dietary habits as measured by the Food Habits Questionnaire
Measured: Up to 6 months following completion of treatment
Sexual functioning as measured by the Sexual Experience Scale score
Measured: Up to 6 months following completion of treatment
Pain as measured by the Brief Pain Questionnaire score
Measured: Up to 6 months following completion of treatment
Fatigue as measured by the Fatigue Severity Index score
Measured: Up to 6 months following completion of treatment
Sleep as measured by the Pittsburg Sleep Quality Index
Measured: Up to 6 months following completion of treatment
Secondary outcomes (2)
Patient-reported evaluation of the BBI as measured by the Evaluation of Topics score
Measured: Up to 6 months following completion of treatment
Therapist-reported fidelity/Usage of BBI as measured through logs
Measured: Up to 6 months following completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startJun 2015
- Primary completion18 May 2017
- Study completion18 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rachel Miller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rachel Miller, University of Kentucky
- Investigators
- Rachel Miller, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454036
- Sponsor's protocol ID
- 14-GYN-02-MCC
- Other IDs
- R25CA163197
- Status last verified
- Dec 2017
- First submitted
- 21 May 2015
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Changes in Cancer Patients Receiving a Biobehavioral Intervention: A Program Evaluation
- ClinicalTrials.gov ID
- NCT02454036
- Acronym / sponsor ID
- 14-GYN-02-MCC
- Conditions
- Neoplasms, Ovarian Neoplasms, Uterine Neoplasms, Vulva
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Rachel MillerUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 18 May 2017 (actual)
- Study completion
- 18 May 2017 (actual)
- First posted
- 27 May 2015 (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.
Baseline self-report outcome measures will be completed and additional assessments will occur mid-treatment , post-treatment , 3 months following completion of all sessions, and 6 months following completion of all sessions. Patients and therapists will complete the evaluation measures in private (at home, in an office).
At the University of Kentucky Markey Cancer Center, BBI treatment is offered in group and individual formats. The course of individual treatment varies and group treatment consists of 10 1.5-hour weekly sessions in the "intensive" phase, followed by 2 1.5-hour bi-weekly maintenance sessions. Individual treatment is one-on-one. In group treatment, there are typically 6-12 patients per group and 1 or 2 therapists. The intervention helps patients to learn adaptive coping strategies and how to apply them to daily stressors. Additional content discusses use of seeking information, enhancing social support, enhancing body esteem and intimacy, and maintaining positive changes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BBI Intervention | Experimental | Behavioral: BBI interventionBiobehavioral Intervention |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females
- Stage I-IV gynecologic cancer (including ovarian, uterine, cervical, vulvar, or vaginal cancer)
- Undergoing active treatment or in remission and undergoing active surveillance; age ≥21 and ≤80
- Able to speak/read English.
Key exclusion criteria (3 listed)
- Concurrent diagnosis of organic brain syndrome, dementia, mental retardation
- Non-English speaking, or significant sensory deficit
- Major mental illness (e.g., schizophrenia, psychotic disorder).
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 |
|---|---|---|
| BBI interventionAlso: Biobehavioral InterventionPsychological intervention designed to reduce stress and enhance quality of life | Behavioural | BBI Intervention |
Primary outcome
Emotional distress as measured by Profile of Mood States score
Time frame: Up to 6 months following completion of treatment
Cancer specific traumatic stress as measured the by Impact of Events Scale score
Time frame: Up to 6 months following completion of treatment
Social support as measured by the Perceived Social Support from Family score
Time frame: Up to 6 months following completion of treatment
Physical activity as measured by the Godin-Shepard Leisure-Time Physical Activity Questionnaire score
Time frame: Up to 6 months following completion of treatment
Dietary habits as measured by the Food Habits Questionnaire
Time frame: Up to 6 months following completion of treatment
Sexual functioning as measured by the Sexual Experience Scale score
Time frame: Up to 6 months following completion of treatment
Pain as measured by the Brief Pain Questionnaire score
Time frame: Up to 6 months following completion of treatment
Fatigue as measured by the Fatigue Severity Index score
Time frame: Up to 6 months following completion of treatment
Sleep as measured by the Pittsburg Sleep Quality Index
Time frame: Up to 6 months following completion of treatment
2 secondary outcomes
Patient-reported evaluation of the BBI as measured by the Evaluation of Topics score
Time frame: Up to 6 months following completion of treatment
Therapist-reported fidelity/Usage of BBI as measured through logs
Time frame: Up to 6 months following completion of treatment
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 Dec 2017.
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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.
Rachel Miller, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BBI intervention in people with Neoplasms and Ovarian Neoplasms, run by Rachel Miller 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 4 inclusion and 3 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 Dec 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Emotional distress as measured by Profile of Mood States score (time frame: Up to 6 months following completion of treatment). The study lists 9 primary outcomes in all. 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 6 Dec 2017.