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NCT Number: NCT06813001

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

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.

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Key information

Conditions

Ovarian Neoplasm ; Psychological Distress Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

19 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACT-based nursing intervention

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiyeon Lee, RN, NP, Ph.D

CONTACT

[email protected]

82-2-2228-3255

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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