NCT03681405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 24, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 7, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 24, 2021

Completed
Last Updated

November 8, 2021

Status Verified

November 1, 2021

Enrollment Period

1.3 years

First QC Date

August 31, 2018

Results QC Date

May 6, 2021

Last Update Submit

November 5, 2021

Conditions

Ovarian NeoplasmUterine Neoplasm

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants Retained in the Study

    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.

    Up to 2 weeks

  • Percentage of Participants That Were Adhered to the Intervention

    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.

    Up to 5 weeks

Secondary Outcomes (7)

  • Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)

    Baseline, 2 weeks and 4 weeks

  • Change in Affective Dimension of Pain

    Baseline, 2 weeks and 4 weeks

  • Change in Pain Interference Per PROMIS Measure

    Baseline, 2 weeks and 4 weeks

  • Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form

    Baseline, 2 weeks and 4 weeks

  • Change in Psychological Distress Per PROMIS Depression

    Baseline, 2 weeks and 4 weeks

  • +2 more secondary outcomes

Study Arms (2)

Group I (eMMB)

EXPERIMENTAL

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.

Other: Informational InterventionOther: Questionnaire Administration

Group II (AC)

ACTIVE COMPARATOR

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.

Other: Questionnaire AdministrationBehavioral: Telephone-Based Intervention

Interventions

Informational InterventionOTHER

Given information about mindful movement and breathing

Group I (eMMB)
Questionnaire AdministrationOTHER

Ancillary studies

Group I (eMMB)Group II (AC)
Telephone-Based InterventionBEHAVIORAL

Receive caring attention phone call

Group II (AC)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

  • Sohl SJ, Strahley AE, Tooze JA, Levine BJ, Kelly MG, Wheeler A, Evans S, Danhauer SC. Qualitative results from a randomized pilot study of eHealth Mindful Movement and Breathing to improve gynecologic cancer surgery outcomes. J Psychosoc Oncol. 2024;42(2):223-241. doi: 10.1080/07347332.2023.2236083. Epub 2023 Jul 18.

    PMID: 37462260DERIVED

MeSH Terms

Conditions

Ovarian NeoplasmsUterine Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine Diseases

Results Point of Contact

Title
Meg O'Mara
Organization
Wake Forest Baptist Comprehensive Cancer Center
megreen@wakehealth.edu
336-716-9055

Study Officials

  • Stephanie Sohl

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 24, 2018

Study Start

December 7, 2018

Primary Completion

April 9, 2020

Study Completion

April 9, 2020

Last Updated

November 8, 2021

Results First Posted

June 24, 2021

Record last verified: 2021-11

Locations

US(1)