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

Not Applicable

Not yet recruiting

• Conditions: Ovarian Neoplasm ; Psychological Distress

• Registration Number: NCT06813001
• Lead Sponsor: Yonsei University

Brief Summary

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.

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 Timeline

• Status Verified: 2025-02
• Study Start: 2025-02
• Study First Submitted: 2025-02-02
• Study First Submitted QC: 2025-02-02
• Last Update Submitted: 2025-02-02
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline depression	within 3 weeks after the last day of self-monitoring (window: 7 days)	depression measured by the Hospital Anxiety and Depression Scale (HADS).
Change from anxiety	within 3 weeks after the last day of self-monitoring (window: 7 days)	Anxiety by the Hospital Anxiety and Depression Scale (HADS).
Change from fear of cancer recurrence	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).
Change from psychological flexibility	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).
Change from quality of life	within 3 weeks after the last day of self-monitoring (window: 7 days)	Quality of life measured by the ECORTC QLQ C-30.
Change from symptoms	within 3 weeks after the last day of self-monitoring (window: 7 days)	Symptoms measured by the EORTC QLQ-OV28.