Uterine Cervical NeoplasmsNCT02444195
Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients
A study testing Guided Imagery With Audio Media in people with Uterine Cervical Neoplasms and Uterine Neoplasms, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of self-administered perioperative guided imagery to reduce perioperative distress in gynecologic oncology patients undergoing surgical management for a presumed cancer diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Neoplasms, Uterine Neoplasms, Ovarian Neoplasms
- What is being tested?
- Guided Imagery With Audio Media
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 1 May 2016
- 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
- Undergoing surgical management for a suspected diagnosis of Gynecologic Malignancy (Endometrial, Ovarian, Vulvar, Vaginal, Primary Peritoneal, Fallopian Tube)
- Age 18 or greater
- Receiving care at University of Michigan Comprehensive Cancer Center Gynecologic Oncology Clinic or at St. Joseph Mercy Hospital, Alexander Cancer Care Center
- Able to understand and read English
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Patients must have working telephone, mobile or land line
Who cannot join
- Severe hearing impairment that limits the ability to use audio-based guided imagery modules
- Current documented alcohol abuse or illicit drug substance abuse
- Planned outpatient surgery
- Patients currently participating in a meditation practice for more than 1 hour per week prior to preoperative visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Self-Administered Guided Imagery in the Perioperative Period to Reduce Postoperative Distress in Gynecologic Oncology Patients: A Randomized Control Trial
The purpose of this study is to evaluate the effectiveness of self-administered perioperative guided imagery to reduce perioperative distress in gynecologic oncology patients undergoing surgical management for a presumed cancer diagnosis.
- Conditions
- Uterine Cervical Neoplasms, Uterine Neoplasms, Ovarian Neoplasms, Urogenital Neoplasms, Fallopian Tube Neoplasms
- Being tested
- Guided Imagery With Audio Media
- Keywords
- gynecologic cancer, guided imagery, postoperative distress, perioperative distress
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Neoplasms, Ovarian Neoplasms, Urogenital Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Imagery With Audio MediaBehavioural
Subjects assigned to the experimental arm will be asked to participate in meditation daily using the audio media provided for the 7 days prior to surgery, in the preoperative holding area, for the 7 days following surgery, and are encouraged to engage in affirmations module use at least weekly in the 6-8 week postoperative period.
| Study group | Role | What they receive |
|---|---|---|
| Guided Imagery | Experimental | Guided Imagery With Audio Media Receives: Behavioral: Guided Imagery With Audio Media |
| Routine Postoperative Care | No intervention | Subjects will receive routine pre-operative, intra-operative, post-operative, chemotherapy, and radiation care as dictated by pathologic diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of distress in the immediate postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.
Measured: postoperative day 1
Level of distress in the delayed postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.
Measured: 6-8 week postoperative exam
Secondary outcomes (8)
Level of distress, measured by questionnaire using the Hospital Anxiety and Depression Scale-total (HADS-T).
Measured: postoperative day 1 and 6-8 week postoperative exam
Level of anxiety and depressions, measured by questionnaire using the Hospital Anxiety and Depression Scale subscale for anxiety (HADS-A) and depression (HADS-D).
Measured: postoperative day 1 and 6-8 week postoperative exam
Level of pain, measured by a 7-item questionnaire using a Likert numerical rating scale for pain
Measured: postoperative day 1 and 6-8 week postoperative exam
Perioperative analgesic use, measured by patient-completed usage log and hospital medical record.
Measured: postoperative day 1 and 6-8 week postoperative exam
Patient satisfaction regarding in hospital perioperative care, measured by a questionnaire adapted from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.
Measured: postoperative day 1 and 6-8 week postoperative exam
Effect of perioperative guided imagery on health care compliance, measured by the General Adherence Scale (GAS) survey.
Measured: 6-8 week postoperative visit
Effect of perioperative guided imagery on health care related locus of control, measured by the Multidimensional Health Locus of Control-form A (MHLC-A) questionnaire.
Measured: postoperative day 1 and 6-8 week postoperative exam
The effect of perioperative guided imagery on hope, measured by the Adult Hope Scale (AHS) questionnaire.
Measured: postoperative day 1 and 6-8 week postoperative exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startApr 2015
- Primary completion1 May 2016
- Study completion1 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandy Michaels, University of Michigan
- Investigators
- Brandy Michaels, MD, Principal investigator, University of MichiganJ. Rebecca Liu, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444195
- Sponsor's protocol ID
- HUM00095520
- Status last verified
- Mar 2017
- First submitted
- 7 May 2015
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Administered Guided Imagery in the Perioperative Period to Reduce Postoperative Distress in Gynecologic Oncology Patients: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02444195
- Acronym / sponsor ID
- HUM00095520
- Conditions
- Uterine Cervical Neoplasms, Uterine Neoplasms, Ovarian Neoplasms, Urogenital Neoplasms, Fallopian Tube Neoplasms
- Keywords
- gynecologic cancer, guided imagery, postoperative distress, perioperative distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 May 2016 (actual)
- First posted
- 14 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.
The purpose of this study is to evaluate the effectiveness of self-administered perioperative guided imagery to reduce perioperative distress in gynecologic oncology patients undergoing surgical management for a presumed cancer diagnosis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery | Experimental | Behavioral: Guided Imagery With Audio MediaGuided Imagery With Audio Media |
| Routine Postoperative Care | No intervention | –Subjects will receive routine pre-operative, intra-operative, post-operative, chemotherapy, and radiation care as dictated by pathologic diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Undergoing surgical management for a suspected diagnosis of Gynecologic Malignancy (Endometrial, Ovarian, Vulvar, Vaginal, Primary Peritoneal, Fallopian Tube)
- Age 18 or greater
- Receiving care at University of Michigan Comprehensive Cancer Center Gynecologic Oncology Clinic or at St. Joseph Mercy Hospital, Alexander Cancer Care Center
- Able to understand and read English
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Key exclusion criteria (4 listed)
- Severe hearing impairment that limits the ability to use audio-based guided imagery modules
- Current documented alcohol abuse or illicit drug substance abuse
- Planned outpatient surgery
- Patients currently participating in a meditation practice for more than 1 hour per week prior to preoperative visit.
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 |
|---|---|---|
| Guided Imagery With Audio MediaSubjects assigned to the experimental arm will be asked to participate in meditation daily using the audio media provided for the 7 days prior to surgery, in the preoperative holding area, for the 7 days following surgery, and are encouraged to engage in affirmations module use at least weekly in the 6-8 week postoperative period. | Behavioural | Guided Imagery |
Primary outcome
Level of distress in the immediate postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.
Time frame: postoperative day 1
Level of distress in the delayed postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.
Time frame: 6-8 week postoperative exam
8 secondary outcomes
Level of distress, measured by questionnaire using the Hospital Anxiety and Depression Scale-total (HADS-T).
Time frame: postoperative day 1 and 6-8 week postoperative exam
Level of anxiety and depressions, measured by questionnaire using the Hospital Anxiety and Depression Scale subscale for anxiety (HADS-A) and depression (HADS-D).
Time frame: postoperative day 1 and 6-8 week postoperative exam
Level of pain, measured by a 7-item questionnaire using a Likert numerical rating scale for pain
Time frame: postoperative day 1 and 6-8 week postoperative exam
Perioperative analgesic use, measured by patient-completed usage log and hospital medical record.
Time frame: postoperative day 1 and 6-8 week postoperative exam
Patient satisfaction regarding in hospital perioperative care, measured by a questionnaire adapted from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.
Time frame: postoperative day 1 and 6-8 week postoperative exam
Effect of perioperative guided imagery on health care compliance, measured by the General Adherence Scale (GAS) survey.
Time frame: 6-8 week postoperative visit
Effect of perioperative guided imagery on health care related locus of control, measured by the Multidimensional Health Locus of Control-form A (MHLC-A) questionnaire.
Time frame: postoperative day 1 and 6-8 week postoperative exam
The effect of perioperative guided imagery on hope, measured by the Adult Hope Scale (AHS) questionnaire.
Time frame: postoperative day 1 and 6-8 week postoperative exam
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 20 Mar 2017.
- 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.
Brandy Michaels, MD principal investigator
University of Michigan
J. Rebecca Liu, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery With Audio Media in people with Uterine Cervical Neoplasms and Uterine Neoplasms, run by University of Michigan 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 6 inclusion and 4 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 20 Mar 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.
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?
Level of distress in the immediate postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument. (time frame: postoperative day 1). 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?
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 20 Mar 2017.