Clinical trial NCT06813001: ACT-Based Nursing Intervention for Ovarian Cancer Patients: A Pilot Study
Official title: Development of ACT (Acceptance and Commitment Therapy)-Based Nurse-led Intervention for Ovarian Cancer Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ovarian Neoplasm ; Psychological Distress
Keywords: Ovarian Neoplasms
Psychological Distress
Acceptand and Commitment Therapy (ACT)
Nursing intervention
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 25
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change from baseline psychological distress on the last day of self-monitoring (Day 8)
timeFrame: Psychological distress will be assessed at baseline and on the last day of self-monitoring (Day 8).
Secondary outcomes:
measure: Change from baseline depression
timeFrame: within 3 weeks after the last day of self-monitoring (window: 7 days)
measure: Change from anxiety
timeFrame: within 3 weeks after the last day of self-monitoring (window: 7 days)
measure: Change from fear of cancer recurrence
timeFrame: within 3 weeks after the last day of self-monitoring (window: 7 days)
measure: Change from psychological flexibility
timeFrame: within 3 weeks after the last day of self-monitoring (window: 7 days)
measure: Change from quality of life
timeFrame: within 3 weeks after the last day of self-monitoring (window: 7 days)
measure: Change from symptoms
timeFrame: within 3 weeks after the last day of self-monitoring (window: 7 days)
Other outcomes:
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