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

NCT ID: NCT06813001

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2025-06-30

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.

Conditions

Ovarian Neoplasm ; Psychological Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

A

Experimental group with application of ACT-based nursing intervention

Group Type: EXPERIMENTAL

ACT-based nursing intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jiyeon Lee, RN, NP, Ph.D

Role: CONTACT

jiyeonest@yuhs.ac

82-2-2228-3255

Other Identifiers

4-2024-1286

Identifier Type: -

Identifier Source: org_study_id