A Blended e-Health Intervention to Improve Fear of Progression in Women With Gynecologic or Breast Cancer

Официальное название

An e-Health Intervention for Fear of Progression in Women With Gynecologic or Breast Cancer

Обзор

This clinical trial studies whether an intervention supported by technology (blended e-health intervention) works to improve fear of progression (FOP) in women with gynecologic or breast cancer. FOP is the fear patients experience from the possibility that their cancer could grow, spread, or get worse. Managing FOP is a leading unmet concern of cancer patients. High levels of FOP are associated with distress, depression, and increased health care costs, despite this, access to resources to address FOP remain limited. The blended e-health intervention in this trial offers remote group sessions along with online sessions to help patients access the information. Session content incorporates values-based goal setting and skills practices to manage unhelpful beliefs about worry and promote helpful coping behaviors. The sessions may help patients recognize unhelpful thoughts and behaviors which reinforce worry. A blended e-health intervention may be an effective way to improve FOP in women with gynecologic or breast cancer.

Подробное описание

PRIMARY OBJECTIVE:

I. To determine the feasibility and acceptability of a blended e-health intervention to manage FOP in patients with stage III or IV gynecologic (GYN) or breast cancer.

SECONDARY (EXPLORATORY) OBJECTIVE:

I. To determine the effects of the intervention on reducing fear of cancer progression (FOP) (primary outcome) and improving secondary outcomes of distress, anxiety, metacognitions, and mindfulness.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients participate in the Mindful Living Program over 6 weeks consisting of group sessions over 60 minutes each during weeks 1, 3, and 6 and online sessions during weeks 2, 4, and 5. Patients also practice skills related to attention training, detached mindfulness, worry postponement, guided imagery, and other mindfulness practices 10-12 minutes daily for 6 days a week. Additionally, patients receive a check-in call over 15-20 minutes at week 3-4 and access to videos as well as a website containing a journal, community forum, and resource library on study.

ARM II: Patients participate in the Navigating Cancer Program over 6 weeks consisting of group sessions over 60 minutes each during weeks 1, 3, and 6 and online sessions during weeks 2, 4, and 5. Patients also receive a check-in call over 15-20 minutes at week 3-4.

After completion of study intervention, patients are followed up at week 12.

Вмешательства

• Другое Best Practice
  Participate in Navigating Cancer Program
• Другое Interview
  Ancillary studies
• Другое Supportive Care
  Participate in Mindful Living Program
• Другое Supportive Care
  Complete skills practice
• Другое Supportive Care
  Receive access to videos and website
• Другое Survey Administration
  Ancillary studies
• Поведенческое Telephone-Based Intervention
  Receive check-in call

Первичные конечные точки

• Recruitment rate (Feasibility of enrollment) [Срок оценки: Up to 18 months]
• Attrition rate (Intervention feasibility) [Срок оценки: Up to 6 weeks]
• Percentage of Attendance/Sessions Completed [Срок оценки: Up to 6 weeks]
• System Usability Scale survey (Acceptability) [Срок оценки: At week 6 (T2)]
• Engagement measures [Срок оценки: Up to 6 weeks]
• Themes From Open-Ended System Usability Scale Responses and Open-Ended Exit Interview Questions [Срок оценки: Up to 14 months]
• Change in fear of progression [Срок оценки: At baseline (T1), 6 weeks (T2), and 12 weeks (T3)]

Вторичные конечные точки (4)

• Change in cancer-specific distress [Срок оценки: At baseline (T1), 6 weeks (T2) and 12 weeks (T3).]
• Change in Anxiety (PROMIS Anxiety 8a): [Срок оценки: At Baseline (T1), 6 weeks (T2) and 12 weeks (T3).]
• Change in metacognitions [Срок оценки: At Baseline (T1), 6 weeks (T2) and 12 weeks (T3).]
• Change in mindfulness [Срок оценки: At Baseline T1, 6 weeks (T2) and 12 weeks (T3)]

Критерии участия

Критерии включения

• Women with stage III or IV GYN (ovarian, endometrial, cervical, vulvar/vaginal) or breast cancer who are at least 2 months from initial diagnosis OR Women with stage I or II endometrial, ovarian, or breast cancer with carcinosarcoma histology OR Women with stage I or II triple negative breast cancer
• Score ≥ 34 on the Fear of Progression Short-Form, indicating dysfunctional levels
• Age 18 or older; able to read and understand English
• Patients can be on active treatment or surveillance. They can be no evidence of disease (NED), recurrent or with progressive disease

Критерии исключения

• Enrolled in hospice
• Ongoing uncontrolled active psychiatric condition that, in the opinion of the investigator, would interfere in the conduct of the study (e.g., mood disorders, psychosis disorders, or substance use), Major depression as assessed by Patient Health Questionnaire-9 (PHQ-9)
• Non-English speaking
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
• Current participation in a mind-body or mindfulness education program within the past six weeks

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• City of Hope Medical Center — Duarte
• City of Hope at Irvine Lennar — Irvine

Идентификаторы

NCT: NCT07741968 · 260057 · NCI-2026-04005 · 260057 · P30CA033572 · R21CA293326

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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