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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06813001
Enrollment
25
Registered
2025-02-06
Start date
2025-02-28
Completion date
2025-06-30
Last updated
2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Neoplasm ; Psychological Distress

Keywords

Ovarian Neoplasms, Psychological Distress, Acceptand and Commitment Therapy (ACT), Nursing intervention

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.

Interventions

OTHERACT-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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Change from anxietywithin 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 recurrencewithin 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 baseline depressionwithin 3 weeks after the last day of self-monitoring (window: 7 days)depression measured by the Hospital Anxiety and Depression Scale (HADS).
Change from quality of lifewithin 3 weeks after the last day of self-monitoring (window: 7 days)Quality of life measured by the ECORTC QLQ C-30.
Change from symptomswithin 3 weeks after the last day of self-monitoring (window: 7 days)Symptoms measured by the EORTC QLQ-OV28.
Change from psychological flexibilitywithin 3 weeks after the last day of self-monitoring (window: 7 days)Psychological flexibility measured by the Acceptance and Action Questionnaire-II (AAQ-II).

Contacts

Primary ContactJiyeon Lee, RN, NP, Ph.D
jiyeonest@yuhs.ac82-2-2228-3255

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026