AnxietyPEACENCT05285306
Surveillance Pelvic Examination Anxiety: Brief Coping Skills Intervention
A study testing PEACE Program in people with Anxiety, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to test the feasibility and acceptability of a brief coping skills training program addressing anxiety and pain related to surveillance pelvic examinations for female gynecologic cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- PEACE Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to 2 Sep 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female sex
- diagnosis of stage I-IV cervical or endometrial cancer
- 18 years of age or older
- able to speak/read English
- able to give informed consent
- completed cancer treatments within 2-24 months prior to enrollment, and recommended to undergo surveillance pelvic examination at three month intervals
- able to commit to three 45-60 minute visits within the study period
- able to participate in the intervention via the telemedicine modality (e.g., phone or video)
Who cannot join
- unable to provide informed consent
- major untreated or uncontrolled mental illness
- hearing impairment that impedes telephone or video calls
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Developing and Pilot Testing a Brief Intervention to Reduce Anxiety During Pelvic Examinations Among Female Cancer Survivors (Pelvic Examination and Anxiety Coping Skills for Empowerment: PEACE)
The purpose of this study is to test the feasibility and acceptability of a brief coping skills training program addressing anxiety and pain related to surveillance pelvic examinations for female gynecologic cancer survivors.
Read the detailed description
The investigators have developed and manualized a coping skills training intervention for female gynecologic cancer patients that aims to reduce anxiety related to surveillance pelvic examinations (Pelvic Examination and Anxiety Coping Skills for Empowerment: PEACE). The investigators propose a proof-of concept pilot study to evaluate the acceptability and feasibility of the coping skills intervention. The study will be conducted by Duke University. Participants (N=16) will receive the 3-session telemedicine coping skills intervention. Participants will complete assessments at baseline, post-intervention (within 2 weeks before their next scheduled pelvic examination), and post pelvic examination (2-3 months after the baseline assessment). Study aims are: Aim 1) Assess intervention acceptability and feasibility through quantitative measurement and qualitative feedback from semi-structured interviews, and Aim 2) Graphically depict patterns of change in outcome variables and intervention targets.
- Conditions
- Anxiety
- Being tested
- PEACE Program
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEACE ProgramBehavioural
Also called Pelvic Exam and Anxiety Coping Skills for Empowerment
This pilot will consist of 3 individual telemedicine sessions to teach cognitive behavioral coping skills and provide education related to gynecologic cancer surveillance and psychological distress.
| Study group | Role | What they receive |
|---|---|---|
| PEACE Program | Experimental | 3 sessions of tailored coping skills related to pelvic examinations Receives: Behavioral: PEACE Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention acceptability will be assessed using an adapted version of the Satisfaction with Therapy and Therapist Scale (STTS-R)
The adapted STTS-R consists of 18 items that assess satisfaction with the therapist and the intervention on a 5-point Likert-type scale from 1 (strongly disagree) to 5 (strongly agree).
Measured: post pelvic examination (approximately 2-3 months after baseline)
Change in intervention acceptability will be assessed using an adapted version of the Satisfaction with Therapy and Therapist Scale (STTS-R)
Change in intervention acceptability from immediately after completion of the 3 sessions (post intervention assessment) to after trying to implement the coping skills during their next pelvic examination (post pelvic exam assessment), using the STTS-R. The adapted STTS-R consists of 18 items that assess satisfaction with the therapist and the intervention on a 5-point Likert-type scale from 1 (strongly disagree) to 5 (strongly agree).
Measured: post-intervention (within 2 weeks of their next pelvic examination), post pelvic examination (approximately 2-3 months after baseline)
Intervention feasibility as measured by percentage of recruited participants who enrolled
Enrollment logs will capture the number of participants who were recruited and among them, the number that enrolled in the study.
Measured: post pelvic examination (approximately 2-3 months after baseline)
Intervention feasibility as measured by attrition
Retention logs will capture the number of participants who did not complete the study protocol (rate of attrition)
Measured: post pelvic examination (approximately 2-3 months after baseline)
Intervention feasibility as measured by survey completion
Retention logs will capture the number of participants who completed all assessments
Measured: post pelvic examination (approximately 2-3 months after baseline)
Intervention feasibility as measured by home practice completion
Interventionist logs completed at the conclusion of each session will capture the level of home practice completion
Measured: post-intervention (within 2 weeks of their next pelvic examination)
Intervention feasibility as measured by participant engagement
Interventionist logs completed at the conclusion of each session will capture the level of participant engagement with a 1 item question rated from 1 (not at all engaged) to 4 (highly engaged).
Measured: post-intervention (within 2 weeks of their next pelvic examination)
Intervention feasibility as measured by interventionist fidelity
Fidelity rating forms will be used to measure the level of fidelity to session content for one third of the sessions for the protocol. Each component of the session will be rated from 0 (not covered at all) to 3 (thoroughly covered the topic)
Measured: post-intervention (within 2 weeks of their next pelvic examination)
Secondary outcomes (2)
Change in anxiety related to examination as measured by the The State Anxiety Scale of the State-Trait Anxiety Inventory
The State Anxiety Scale of the STAI is comprised of 20 items on a 5-point Likert scale, which range from 1 (not at all) through 4 (very much).
Measured: baseline, post-intervention (within 2 weeks of their next pelvic examination), post pelvic examination (approximately 2-3 months after baseline)
Change in pain during examination as measured by numeric scales
Numeric scales will be used to assess the average pain during examination, worst pain during examination, and lowest pain during examination, ranging from 0 (no pain) to 10 (pain as bad as you could imagine). The three pain intensity ratings will be averaged to create a total score for pain.
Measured: baseline, post pelvic examination (approximately 2-3 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start21 Mar 2022
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Shelby, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285306
- Sponsor's protocol ID
- PRO00107843
- Acronym
- PEACE
- Status last verified
- Nov 2021
- First submitted
- 7 Mar 2022
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Pilot Testing a Brief Intervention to Reduce Anxiety During Pelvic Examinations Among Female Cancer Survivors (Pelvic Examination and Anxiety Coping Skills for Empowerment: PEACE)
- ClinicalTrials.gov ID
- NCT05285306
- Acronym / sponsor ID
- PEACE / PRO00107843
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 17 Mar 2022 (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.
The purpose of this study is to test the feasibility and acceptability of a brief coping skills training program addressing anxiety and pain related to surveillance pelvic examinations for female gynecologic cancer survivors.
Detailed description
The investigators have developed and manualized a coping skills training intervention for female gynecologic cancer patients that aims to reduce anxiety related to surveillance pelvic examinations (Pelvic Examination and Anxiety Coping Skills for Empowerment: PEACE). The investigators propose a proof-of concept pilot study to evaluate the acceptability and feasibility of the coping skills intervention. The study will be conducted by Duke University. Participants (N=16) will receive the 3-session telemedicine coping skills intervention. Participants will complete assessments at baseline, post-intervention (within 2 weeks before their next scheduled pelvic examination), and post pelvic examination (2-3 months after the baseline assessment). Study aims are: Aim 1) Assess intervention acceptability and feasibility through quantitative measurement and qualitative feedback from semi-structured interviews, and Aim 2) Graphically depict patterns of change in outcome variables and intervention targets.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEACE Program | Experimental | Behavioral: PEACE Program3 sessions of tailored coping skills related to pelvic examinations |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- female sex
- diagnosis of stage I-IV cervical or endometrial cancer
- 18 years of age or older
- able to speak/read English
- able to give informed consent
Key exclusion criteria (3 listed)
- unable to provide informed consent
- major untreated or uncontrolled mental illness
- hearing impairment that impedes telephone or video calls
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 |
|---|---|---|
| PEACE ProgramAlso: Pelvic Exam and Anxiety Coping Skills for EmpowermentThis pilot will consist of 3 individual telemedicine sessions to teach cognitive behavioral coping skills and provide education related to gynecologic cancer surveillance and psychological distress. | Behavioural | PEACE Program |
Primary outcome
Intervention acceptability will be assessed using an adapted version of the Satisfaction with Therapy and Therapist Scale (STTS-R)
Time frame: post pelvic examination (approximately 2-3 months after baseline)
The adapted STTS-R consists of 18 items that assess satisfaction with the therapist and the intervention on a 5-point Likert-type scale from 1 (strongly disagree) to 5 (strongly agree).
Change in intervention acceptability will be assessed using an adapted version of the Satisfaction with Therapy and Therapist Scale (STTS-R)
Time frame: post-intervention (within 2 weeks of their next pelvic examination), post pelvic examination (approximately 2-3 months after baseline)
Change in intervention acceptability from immediately after completion of the 3 sessions (post intervention assessment) to after trying to implement the coping skills during their next pelvic examination (post pelvic exam assessment), using the STTS-R. The adapted STTS-R consists of 18 items that assess satisfaction with the therapist and the intervention on a 5-point Likert-type scale from 1 (strongly disagree) to 5 (strongly agree).
Intervention feasibility as measured by percentage of recruited participants who enrolled
Time frame: post pelvic examination (approximately 2-3 months after baseline)
Enrollment logs will capture the number of participants who were recruited and among them, the number that enrolled in the study.
Intervention feasibility as measured by attrition
Time frame: post pelvic examination (approximately 2-3 months after baseline)
Retention logs will capture the number of participants who did not complete the study protocol (rate of attrition)
Intervention feasibility as measured by survey completion
Time frame: post pelvic examination (approximately 2-3 months after baseline)
Retention logs will capture the number of participants who completed all assessments
Intervention feasibility as measured by home practice completion
Time frame: post-intervention (within 2 weeks of their next pelvic examination)
Interventionist logs completed at the conclusion of each session will capture the level of home practice completion
Intervention feasibility as measured by participant engagement
Time frame: post-intervention (within 2 weeks of their next pelvic examination)
Interventionist logs completed at the conclusion of each session will capture the level of participant engagement with a 1 item question rated from 1 (not at all engaged) to 4 (highly engaged).
Intervention feasibility as measured by interventionist fidelity
Time frame: post-intervention (within 2 weeks of their next pelvic examination)
Fidelity rating forms will be used to measure the level of fidelity to session content for one third of the sessions for the protocol. Each component of the session will be rated from 0 (not covered at all) to 3 (thoroughly covered the topic)
2 secondary outcomes
Change in anxiety related to examination as measured by the The State Anxiety Scale of the State-Trait Anxiety Inventory
Time frame: baseline, post-intervention (within 2 weeks of their next pelvic examination), post pelvic examination (approximately 2-3 months after baseline)
Change in pain during examination as measured by numeric scales
Time frame: baseline, post pelvic examination (approximately 2-3 months after baseline)
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 11 May 2023.
- Individual participant dataSharing planned: No
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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.
Rebecca Shelby, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEACE Program in people with Anxiety, run by Duke University 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 8 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 11 May 2023. 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?
Intervention acceptability will be assessed using an adapted version of the Satisfaction with Therapy and Therapist Scale (STTS-R) (time frame: post pelvic examination (approximately 2-3 months after baseline)). The study lists 8 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 11 May 2023.