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Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery

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ClinicalTrials.gov Identifier: NCT03681405
Recruitment Status : Not yet recruiting
First Posted : September 24, 2018
Last Update Posted : December 3, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
This trial studies how well two different supportive programs work in supporting optimal recovery in participants undergoing gynecological surgery. Supportive programs use different methods for helping participants cope with the surgical experience including gentle movements, counseling, writing, or relaxation techniques, and may help improve participants' well-being after gynecological surgery.

Condition or disease Intervention/treatment Phase
Ovarian Neoplasm Uterine Neoplasm Other: Informational Intervention Other: Questionnaire Administration Behavioral: Telephone-Based Intervention Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To calculate recruitment, adherence, assessment completion, and retention rates.

SECONDARY OBJECTIVES:

I. Document the frequency of adverse events. II. Assess descriptive data on proposed outcomes (i.e., pain, sleep disturbances, psychological distress) for the next phase of study.) III. Qualitatively assess acceptability to guide future study planning.

OUTLINE: Participants are randomized to 1 of 2 groups.

GRUOP I (MINDFUL MOVEMENT AND BREATHING [eMMB]): Participants receive information about the intervention individually via telephone and video conference on postoperative day 1 or as soon as feasible. Participants also have access to a video or written information before participating in 20 minutes of awareness meditation, gentle movements, and breathing/relaxation techniques daily for 2 weeks.

GROUP II (ATTENTION CONTROL [AC]): Participants receive caring attention from an interventionist via telephone or video conference over 30 minutes on postoperative day 1 or as soon as feasible.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I (eMMB)
Participants receive information about the intervention individually via telephone and video conference on postoperative day 1 or as soon as feasible. Participants also have access to a video or written information before participating in 20 minutes of awareness meditation, gentle movements, and breathing/relaxation techniques daily for 2 weeks.
Other: Informational Intervention
Given information about mindful movement and breathing

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Group II (AC)
Participants receive caring attention from an interventionist via telephone or video conference over 30 minutes on postoperative day 1 or as soon as feasible.
Other: Questionnaire Administration
Ancillary studies

Behavioral: Telephone-Based Intervention
Receive caring attention phone call




Primary Outcome Measures :
  1. Number of participants that were screened and retained in the study [ Time Frame: Up to 5 weeks ]
    Will provide quantitative data to guide future study planning. Will calculate 95% confidence intervals for each of the feasibility measures to determine the range of estimates that are consistent with the data. Will track the number of screened participants, those who are eligible, and the percent who agree to participate. For those not meeting the eligibility criteria, reasons will be summarized. The proportion of participants and corresponding 95% CI for participants who participated in each group will be computed. Will use one-sample tests of binomial proportions to compare the recruitment, adherence, and retention rates to the hypothesized values of 50%, 70% and 70%, respectively.


Secondary Outcome Measures :
  1. Pain intensity per Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Baseline and at week 2 ]

    Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Additional analyses will include fitting mixed analysis of covariance (ANCOVA) models (adjustment for baseline) to model the trajectory of pain by time and group accounting for the repeated measures on a subject.

    The PROMIS assesses pain on a numeric rating scale from 0 (no pain) to 10 (worst imaginable pain)


  2. Pain interference per 9 patient-reported items [ Time Frame: Baseline and at week 2 ]
    Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Additional analyses will include fitting mixed analysis of covariance (ANCOVA) models (adjustment for baseline) to model the trajectory of pain by time and group accounting for the repeated measures on a subject.

  3. Pain interference per PROMIS measure [ Time Frame: Baseline and at week 2 ]
    Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Additional analyses will include fitting mixed analysis of covariance (ANCOVA) models (adjustment for baseline) to model the trajectory of pain by time and group accounting for the repeated measures on a subject.

  4. Sleep disturbances per PROMIS Sleep Disturbance short-form [ Time Frame: Up to 5 weeks ]
    Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Additional analyses will include fitting mixed analysis of covariance (ANCOVA) models (adjustment for baseline) to model the trajectory of pain by time and group accounting for the repeated measures on a subject.

  5. Psychological distress per PROMIS Depression [ Time Frame: Up to 5 weeks ]
    Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Additional analyses will include fitting mixed analysis of covariance (ANCOVA) models (adjustment for baseline) to model the trajectory of pain by time and group accounting for the repeated measures on a subject.

  6. Psychological distress per PROMIS Anxiety [ Time Frame: Up to 5 weeks ]
    Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Additional analyses will include fitting mixed analysis of covariance (ANCOVA) models (adjustment for baseline) to model the trajectory of pain by time and group accounting for the repeated measures on a subject.

  7. Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 5 weeks ]
    Will describe any adverse events reported as frequencies.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for an abdominal gynecological surgery (i.e. uterine, ovarian) to remove a suspected malignancy.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1.
  • Cognitively able to complete assessments as judged by the study team.
  • Able to understand, read and write English.

Exclusion Criteria:

  • Have schizophrenia or any other psychotic disorder.
  • Have a diagnosed sleep disorder including untreated obstructive sleep apnea, periodic limb movement disorder, or restless leg syndrome.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681405


Locations
United States, North Carolina
Wake Forest University Health Sciences Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Stephanie J. Sohl    336-713-5093    ssohl@wakehealth.edu   
Principal Investigator: Stephanie J. Sohl         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephanie Sohl Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03681405     History of Changes
Other Study ID Numbers: IRB00052655
NCI-2018-01801 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 97218 ( Other Identifier: Wake Forest University Health Sciences )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms
Uterine Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Diseases