Trauma-Focused Managing Cancer And Living Meaningfully (CALM-TF): A Phase III Randomized Controlled Trial of an Intervention Targeting Traumatic Stress in Patients With Advanced Ovarian Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Stanford Acute Stress Reaction Questionnaire-II (SASRQ-II)
研究概览
简要总结
The goal of this clinical trial is to investigate if CALM-TF (Trauma-Focused Managing Cancer and Living Meaningfully) is effective in treating traumatic stress symptoms in women with advanced ovarian cancer. It will also learn whether the efficacy differs at new diagnosis versus at recurrence.
The main questions it aims to answer are:
- What is the effectiveness of CALM-TF in reducing traumatic stress symptoms in patients with newly diagnosed or recurrent advanced ovarian cancer, as measured at 3 and 6 months?
- What are the effects of CALM-TF on depression, quality of life, and patient-perceived benefit of the intervention compared to usual care alone?
- What are patient perceptions of their care experiences as explored through qualitative interviews?
Researchers will compare CALM-TF to usual standard of care (which includes regular conversations with medical teams and meetings with social workers) to see if CALM-TF works to treat traumatic stress.
Participants will:
- Receive 3-6 sessions of CALM-TF over 3-6 months (45-60 minutes each) via video call, telephone, or in-person based on preference, OR receive usual care only
- Complete questionnaires at baseline, 3 months, and 6 months
- Continue to receive their standard cancer care throughout the study
- Some participants may be invited to participate in qualitative interviews at 6 months
详细描述
This study examines whether a brief psychotherapy called Trauma-Focused Managing Cancer and Living Meaningfully (CALM-TF) can help women with advanced ovarian cancer who are experiencing traumatic stress symptoms.
Traumatic stress refers to the psychological impact of traumatic events, which in cancer care includes the diagnosis, progression, or recurrence of advanced disease. Research shows that up to 45% of patients with ovarian cancer experience clinically significant traumatic stress symptoms that meet diagnostic criteria for acute stress disorder.
CALM-TF is a manualized psychotherapeutic intervention that builds on an established therapy called CALM (Managing Cancer and Living Meaningfully), which has previously been shown to reduce depression and improve communication with healthcare providers in patients with advanced cancer. CALM-TF incorporates trauma-focused components specifically designed to address traumatic stress symptoms that arise at the time of diagnosis or recurrence of ovarian cancer.
The intervention consists of 3-6 individual therapy sessions delivered over 3-6 months, with each session lasting 45-60 minutes. Sessions can be conducted via secure video conferencing, telephone, or in-person based on participant preference. The therapy focuses on four interconnected content areas: symptom management and communication with healthcare providers; changes in self and relationships with close others; sense of meaning and purpose in life; and hopes and fears about the future and mortality, with trauma-focused components integrated throughout.
This is a multi-site randomized controlled trial enrolling 300 women with newly diagnosed stage III or IV ovarian cancer or recurrent ovarian cancer (within six months of diagnosis or recurrence). Participants are randomly assigned in a 1:1 ratio to receive either CALM-TF plus usual care or usual care alone. Usual care includes regular conversations with medical teams and meetings with social workers regarding financial or practical issues, with access to specialized psychological support through referral.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data analysts will also be blinded to participant treatment group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed stage III or IV ovarian cancer OR recurrent ovarian cancer within six months of diagnosis or recurrence
- •Age 18 years or older
- •Able to speak and read English
- •Able to provide informed consent
排除标准
- •Significant cognitive impairment that would interfere with the ability to participate in psychotherapy or complete study questionnaires
- •Active psychosis or severe psychiatric condition requiring immediate psychiatric intervention
- •Receiving ongoing psychotherapy at the time of recruitment
研究组 & 干预措施
CALM-TF plus Usual Care
Participants receive Trauma-Focused Managing Cancer and Living Meaningfully (CALM-TF), a brief manualized psychotherapeutic intervention consisting of 3-6 individual sessions over 3-6 months (45-60 minutes each). Sessions delivered via secure video conferencing (Microsoft Teams), telephone, or in-person based on participant preference. Participants also continue to receive usual standard of care throughout the intervention period.
干预措施: Trauma-Focused Managing Cancer and Living Meaningfully (Behavioral)
Usual Care Alone
Participants receive usual standard of care only, which includes frequent conversations with their medical team regarding their care and meetings with social workers regarding financial or other practical issues. Participants have access to formal or specialized psychotherapeutic interventions upon referral by their primary physician or member of their circle of care.
结局指标
主要结局
Stanford Acute Stress Reaction Questionnaire-II (SASRQ-II)
时间窗: From enrolment to the end of study at 6 months
Traumatic stress symptoms are measured by the Stanford Acute Stress Reaction Questionnaire-II (SASRQ-II), a validated 30-item self-report instrument specifically designed to assess traumatic stress symptoms based on DSM-5 criteria. The SASRQ-II provides a total score range of 0-150, where higher scores reflect increasing symptom severity and cut-off scores of \>40 indicate clinically significant traumatic stress symptoms.
次要结局
- Condensed Memorial Symptom Assessment Scale (CMSAS)(From enrolment to the end of the study at 6 months)
- Patient Health Questionnaire (PHQ-9)(From enrolment to the end of the study at 6 months)
- Death and Dying Distress Scale (DADDS)(From enrolment to the end of the study at 6 months)
- Clinical Evaluation Questionnaire (CEQ)(At 3 and 6 month time points.)
- Experiences in Close Relationships-Modified-16 (ECR-M-16)(Baseline only)
- EuroQol 5-Dimension 5-Level Health Questionnaire (EQ-5D-5L Health Questionnaire)(From enrolment to the end of the study at 6 months)
- Short Form 6-Dimensions Health Survey (SF-6D Health Survey)(From enrolment to the end of the study at 6 months)