Female Reproductive System Neoplasm, Malignant Female Reproductive System Neoplasm, Malignant Uterine Neoplasm, Ovarian Carcinoma, Ovarian Neoplasm, Suspicious for Malignancy, Uterine Neoplasm
Conditions
Brief summary
This trial determines how well eHealth mindful movement and breathing works to improve outcomes in participants undergoing gynecologic surgery. Supportive therapy, such as eHealth mindful movement and breathing, uses techniques that include gentle movements, breathing, and relaxation techniques which may help participants cope with and improve their surgical experiences.
Detailed description
PRIMARY OBJECTIVES: I. To field-test implementation strategies of the mindful movement and breathing (eMMB) intervention that has been adapted to the eHealth Format. OUTLINE: Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. After completion of study, participants are followed up at 4 weeks from surgery.
Interventions
OTHERQuestionnaire Administration
Receive questionnaire
PROCEDURESupportive Care
Undergo eHealth mindful moving and breathing
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for an abdominal gynecological surgery (i.e. uterine, ovarian) to remove a mass that is suspected to be malignant * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Confident in the Use of EHealth Format | Up to 4 weeks | This is a feasibility study to iteratively refine the eMMB implementation strategies with 10-15 consecutive participants enrolled. Participants will be asked to complete a brief usability questionnaire about their confidence in their ability to complete the intervention. The number of participants will depend on when a consensus is reached on a manual for implementing interventions and will be determined by calculating 95% confidence intervals around all the secondary outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Recruited and Completed All Assessments | Up to 4 weeks | Participants who were recruited and agreed to participate in the Mindful Movement and Breathing (eMMB) sessions and those who completed all assessments will be computed. |
| Number of Participants That Adhered to Study Interventions | Up to 4 weeks | To be determined by comparing participants who were adherent to attending study visits and interventions by an adherence assessment (1) Completion of the videoconference session; (2) any additional contact with the interventionists; (3) use of the self-directed intervention: |
| Number of Participants Reporting Adverse Events | Up to 4 weeks | Adverse events will be reported upon occurrence monthly. Specifically, they will be labeled definitely unrelated, definitely related, probably related, or possibly related to the study intervention. |
| Percentage of Participants Completing 4-week Visits | Up to 4 weeks | To be assessed by calculating the percent of participants who complete the 4-week visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Supportive Care (eMMB) Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible.
Questionnaire Administration: Receive questionnaire
Supportive Care: Undergo eHealth mindful moving and breathing | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Did not wish to complete follow up | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Overwhelmed, didn't want to continue | 1 |
Baseline characteristics
| Characteristic | Supportive Care (eMMB) |
|---|---|
| Age, Continuous | 58.2 Years STANDARD_DEVIATION 14.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
Primary
Number of Participants Confident in the Use of EHealth Format
This is a feasibility study to iteratively refine the eMMB implementation strategies with 10-15 consecutive participants enrolled. Participants will be asked to complete a brief usability questionnaire about their confidence in their ability to complete the intervention. The number of participants will depend on when a consensus is reached on a manual for implementing interventions and will be determined by calculating 95% confidence intervals around all the secondary outcomes.
Time frame: Up to 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Care (eMMB) | Number of Participants Confident in the Use of EHealth Format | 7 Participants |
Secondary
Number of Participants Recruited and Completed All Assessments
Participants who were recruited and agreed to participate in the Mindful Movement and Breathing (eMMB) sessions and those who completed all assessments will be computed.
Time frame: Up to 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Care (eMMB) | Number of Participants Recruited and Completed All Assessments | 5 Participants |
Secondary
Number of Participants Reporting Adverse Events
Adverse events will be reported upon occurrence monthly. Specifically, they will be labeled definitely unrelated, definitely related, probably related, or possibly related to the study intervention.
Time frame: Up to 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Care (eMMB) | Number of Participants Reporting Adverse Events | 1 Participants |
Secondary
Number of Participants That Adhered to Study Interventions
To be determined by comparing participants who were adherent to attending study visits and interventions by an adherence assessment (1) Completion of the videoconference session; (2) any additional contact with the interventionists; (3) use of the self-directed intervention:
Time frame: Up to 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Care (eMMB) | Number of Participants That Adhered to Study Interventions | 7 Participants |
Secondary
Percentage of Participants Completing 4-week Visits
To be assessed by calculating the percent of participants who complete the 4-week visit.
Time frame: Up to 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Care (eMMB) | Percentage of Participants Completing 4-week Visits | 5 Participants |