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临床试验/NCT06666218
NCT06666218
暂停
不适用

Helping Ovarian Cancer Patients Cope With Their Disease (HOPE) - Phase 2

Fred Hutchinson Cancer Center1 个研究点 分布在 1 个国家目标入组 60 人2025年2月24日

概览

阶段
不适用
干预措施
Behavioral Intervention
疾病 / 适应症
Recurrent Ovarian Carcinoma
发起方
Fred Hutchinson Cancer Center
入组人数
60
试验地点
1
主要终点
Accrual rates (Aim 1)
状态
暂停
最后更新
3个月前

概览

简要总结

This clinical trial compares the effect of the Helping Ovarian Cancer Patients Cope with Their Disease (HOPE) intervention to usual care for the reduction of hopelessness and helplessness in patients with ovarian cancer that has come back after a period of improvement (recurrent). Patients with recurrent ovarian cancer are at high risk for increased death and poor mental health outcomes, including depression and anxiety. Ovarian cancer is the deadliest of all gynecologic cancers, with a survival rate at five years of only 50%. Most patients are diagnosed with advanced disease and have a high chance of recurrent disease that is incurable, even if upfront treatments are effective. Ovarian cancer's advanced diagnosis, high likelihood of recurrence and death, and rigorous treatment including surgery and other cancer therapies create high levels of distress and reduced quality of life (QOL). Patients with recurrent ovarian cancer report high rates of depression and anxiety and poor QOL. Due to the major distress, reduced QOL, and likelihood of death among this population, improving this patient population's QOL is a priority. Using the HOPE intervention may be effective in reducing hopelessness and helplessness in recurrent ovarian cancer patients.

详细描述

OUTLINE: AIM 1: Patients complete the HOPE intervention workshop virtually or in-person. The workshop consists of 3 sessions, each held once per week and lasting 60 to 90 minutes as well as complete a survey and an interview for HOPE intervention refinement during follow up. AIM 2: Patients are randomized to 1 of 2 groups. GROUP I: Patients complete the HOPE intervention workshop virtually or in-person, with 3 sessions held once per week, each lasting 60 to 90 minutes. GROUP II: Patients receive usual care on study. Patients in both groups complete baselines and follow up assessments 5, 8, and 12 weeks after the randomization event.

注册库
clinicaltrials.gov
开始日期
2025年2月24日
结束日期
2027年1月31日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

责任方
Sponsor

入排标准

入选标准

  • Age 18 years of age or older
  • English speaking
  • Able to provide informed consent
  • Current diagnosis of recurrent epithelial ovarian cancer (regardless of the amount of time since the diagnosis, given the poor prognosis of this illness with a median survival time of less than 2 years)

排除标准

  • Patients with non-invasive gynecologic disease (i.e., dysplasia)

研究组 & 干预措施

Aim 1 (HOPE intervention workshop, survey, interview)

Patients complete the HOPE intervention workshop virtually or in person. The workshop consists of three weekly sessions, each lasting 60 to 90 minutes, along with a survey and an interview for HOPE Intervention refinement during follow up.

干预措施: Behavioral Intervention

Aim 1 (HOPE intervention workshop, survey, interview)

Patients complete the HOPE intervention workshop virtually or in person. The workshop consists of three weekly sessions, each lasting 60 to 90 minutes, along with a survey and an interview for HOPE Intervention refinement during follow up.

干预措施: Electronic Health Record Review

Aim 1 (HOPE intervention workshop, survey, interview)

Patients complete the HOPE intervention workshop virtually or in person. The workshop consists of three weekly sessions, each lasting 60 to 90 minutes, along with a survey and an interview for HOPE Intervention refinement during follow up.

干预措施: Interview

Aim 1 (HOPE intervention workshop, survey, interview)

Patients complete the HOPE intervention workshop virtually or in person. The workshop consists of three weekly sessions, each lasting 60 to 90 minutes, along with a survey and an interview for HOPE Intervention refinement during follow up.

干预措施: Survey Administration

Aim 2, Group I (HOPE intervention workshop)

Patients complete the HOPE intervention workshop either virtually or in person, with three weekly sessions, each lasting 60 to 90 minutes.

干预措施: Behavioral Intervention

Aim 2, Group I (HOPE intervention workshop)

Patients complete the HOPE intervention workshop either virtually or in person, with three weekly sessions, each lasting 60 to 90 minutes.

干预措施: Electronic Health Record Review

Aim 2, Group I (HOPE intervention workshop)

Patients complete the HOPE intervention workshop either virtually or in person, with three weekly sessions, each lasting 60 to 90 minutes.

干预措施: Survey Administration

Aim 2, Group II (usual care)

Patients receive usual care on study.

干预措施: Electronic Health Record Review

Aim 2, Group II (usual care)

Patients receive usual care on study.

干预措施: Survey Administration

结局指标

主要结局

Accrual rates (Aim 1)

时间窗: At the time of enrollment

Feasibility will be assessed by accrual rates. Feasibility cutoffs will include \>= 50% of eligible patients will enroll in the study.

Fidelity rates (Aim 1)

时间窗: Up to 28 days

Feasibility will be assessed by fidelity rates. Feasibility cutoffs will include \>= 75% of HOPE workshop sessions delivered with fidelity.

Rates of intervention completion (Aim 1)

时间窗: Up to 28 days

Feasibility will be assessed by rates of intervention completion (all three sessions of Helping Ovarian Cancer Patients Cope with Their Disease \[HOPE\]). Feasibility cutoffs will include 70% of enrolled patients will complete all workshop sessions.

Acceptability of the HOPE intervention (Aim 1)

时间窗: Up to 28 days

Acceptability will be assessed by the Theoretical Framework of Acceptability (TFA) questionnaire, which is an 8-item questionnaire assessing acceptability of healthcare interventions across seven constructions: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness and self-efficacy. The eighth item is a general acceptability item. Items are rated on a 5-point Likert scale (e.g., 1 = strongly dislike, 5 = strongly like) and a mean is computed across all seven constructs and a single outcome is examined for the general item. Scores on the TFA questionnaire will be calculated using the total mean score of seven TFA items. A single-item score will be used for the remaining eighth item, which is a general item assessing acceptability. In this study, will use a cutoff of \>= 70% agreeing (or rating as confident, liking, acceptable) as being acceptable for use.

Overall satisfaction (Aim 1)

时间窗: Up to 28 days

Satisfaction will be assessed by using three items assessing overall satisfaction (How satisfied are you? How likely are you to recommend to someone? How likely would you participate in this workshop knowing what it is like now?). A cutoff score of \>= 7 (out of 10) will be used as a cutoff for each satisfaction item.

Change in hopelessness/helplessness (Aim 2)

时间窗: Baseline to 12 weeks post-randomization

Hopelessness/helplessness will be measured by the helplessness/hopelessness subscale of the Mental Adjustment to Cancer (MAC) scale. The MAC scale is a widely used, 40-item scale that assesses patients' psychological responses to cancer. Items are given as statements (e.g., "I feel that life is hopeless") and patients report their agreement using a 4-point Likert-scale (1 = definitely does not apply to me, 2 = does not apply to me, 3 = applies to me, 4 = definitely applies to me).

次要结局

  • Accrual rates (Aim 2)(At the time of enrollment)
  • Rates of intervention completion (Aim 2)(Up to 35 days)
  • Acceptability of the HOPE intervention (Aim 2)(5-weeks post-randomization)
  • Change in distress (Aim 2)(Baseline to 5 weeks post-randomization)
  • Change in quality of life (QOL) (Aim 2)(Baseline to 5 weeks post-randomization)
  • Change in self-efficacy for treatment decision-making (Aim 2)(Baseline to 5 weeks post-randomization)
  • Change in readiness for advance care planning (ACP) (Aim 2)(Baseline to 5 weeks post-randomization)
  • Change in level of engagement in advance care planning (ACP) (Aim 2)(Baseline to 5 weeks post-randomization)
  • Change in documentation of advance care planning (ACP) conversations (Aim 2)(Baseline to 5 weeks post-randomization)
  • Change in completion of advance care directives (Aim 2)(Baseline to 5 weeks post-randomization)

研究点 (1)

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