Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ovarian Neoplasm
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Retained in the Study
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
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. GROUP I (MINDFUL MOVEMENT AND BREATHING \[eMMB\]): Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery. GROUP II (ATTENTION CONTROL \[AC\]): Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.
Investigators
Eligibility 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 =\<
- •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.
Outcomes
Primary Outcomes
Percentage of Participants Retained in the Study
Time Frame: Up to 2 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.
Percentage of Participants That Were Adhered to the Intervention
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.
Secondary Outcomes
- Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0(Up to 4 weeks)
- Change in Psychological Distress Per PROMIS Depression(Baseline, 2 weeks and 4 weeks)
- Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)(Baseline, 2 weeks and 4 weeks)
- Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form(Baseline, 2 weeks and 4 weeks)
- Change in Affective Dimension of Pain(Baseline, 2 weeks and 4 weeks)
- Change in Psychological Distress Per PROMIS Anxiety(Baseline, 2 weeks and 4 weeks)
- Change in Pain Interference Per PROMIS Measure(Baseline, 2 weeks and 4 weeks)