ACT-Based Nursing Intervention for Ovarian Cancer Patients: A Pilot Study

February 2, 2025 updated by: Yonsei University

Development of ACT (Acceptance and Commitment Therapy)-Based Nurse-led Intervention for Ovarian Cancer Patients

The purpose of this study is to evaluate the feasiblity and effectiveness of an Acceptance and Commitment Therapy (ACT)-based nursing intervention aimed at managing psychological flexibility, distress, anxiety, depression, fear of cancer recurrence/progression, quality of life, and symptoms. Patients will participate in a single online session with a nurse, followed by a daily self-monitoring survey online for one week. Data will be collected at baseline (prior to the ACT session), on day 8 (after one week of self-monitoring), and at 5 weeks. Primary outcome is psychological flexibility.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a preliminary single-group pre-post design aimed at developing and evaluating the feasibility of an ACT-based nursing intervention for distress management in patients with ovarian cancer. A total of 25 ovarian cancer patients who consent to participate will be enrolled in the study. Paticipants will receive a one-time ACT-based nursing intervention lasting approximately 60 minutes.

The researcher will coordinate schedules with participants to deliver the ACT-based nursing intervention using Zoom, a video conferencing platform which minimizes time and location constraints. Before the intervention, the research will ensure that the participants' video conferencing is working properly to minimize potential difficulties during the session.

Following the single-session intervention, the researcher will send a daily Google Form link to participants for seven consecutive days. Participants will be encouraged to access the link and complete self-monitoring surveys to reinforce the key components addressed in the program.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jiyeon Lee, RN, NP, Ph.D
  • Phone Number: 82-2-2228-3255
  • Email: jiyeonest@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • adult (19 ≤ age ≤ 75).
  • ovarian cancer patients with FIGO stage 2-3.
  • Those who have completed first-line chemotherapy for ovarian cancer (excluding maintenance therapy) within the past 2 years.

Exclusion Criteria:

  • Patients with cognitive problems such as dementia or psychiatric problems such as major depression or generalized anxiety, or who are actively receiving treatment for any of these conditions.
  • Patients with history of cancer recurrence.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Experimental group with application of ACT-based nursing intervention
Other: ACT-based nursing intervention
ACT-based nursing intervention is a 1:1 single online session with a nurse, which takes about 60 minutes followed by a daily self-monitoring survey for one week, which encourages patients to practice ACT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline psychological distress on the last day of self-monitoring (Day 8)
Time Frame: Psychological distress will be assessed at baseline and on the last day of self-monitoring (Day 8).
Psychological distress measured by Distress Thermometer.
Psychological distress will be assessed at baseline and on the last day of self-monitoring (Day 8).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline depression
Time Frame: within 3 weeks after the last day of self-monitoring (window: 7 days)
depression measured by the Hospital Anxiety and Depression Scale (HADS).
within 3 weeks after the last day of self-monitoring (window: 7 days)
Change from anxiety
Time Frame: within 3 weeks after the last day of self-monitoring (window: 7 days)
Anxiety by the Hospital Anxiety and Depression Scale (HADS).
within 3 weeks after the last day of self-monitoring (window: 7 days)
Change from fear of cancer recurrence
Time Frame: within 3 weeks after the last day of self-monitoring (window: 7 days)
Fear of cancer recurrence measured by the Fear of Cancer Recurrence Index (FCRI).
within 3 weeks after the last day of self-monitoring (window: 7 days)
Change from psychological flexibility
Time Frame: within 3 weeks after the last day of self-monitoring (window: 7 days)
Psychological flexibility measured by the Acceptance and Action Questionnaire-II (AAQ-II).
within 3 weeks after the last day of self-monitoring (window: 7 days)
Change from quality of life
Time Frame: within 3 weeks after the last day of self-monitoring (window: 7 days)
Quality of life measured by the ECORTC QLQ C-30.
within 3 weeks after the last day of self-monitoring (window: 7 days)
Change from symptoms
Time Frame: within 3 weeks after the last day of self-monitoring (window: 7 days)
Symptoms measured by the EORTC QLQ-OV28.
within 3 weeks after the last day of self-monitoring (window: 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 2, 2025

First Submitted That Met QC Criteria

February 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 2, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2024-1286

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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