Stepped-Care Telehealth for Distress in Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 332
- 主要终点
- Feasibility of Study Intervention Measured by Recruitment Rate
研究概览
简要总结
Mental health issues in post-treatment adult cancer survivors are associated with multiple adverse outcomes and may represent a cancer health disparity for rural survivors. The purpose of this study is to test a stepped-care approach tailored to symptom severity based on recent American Society of Clinical Oncology guidelines for reducing emotional distress (anxiety and/or depressive symptoms) and improving secondary outcomes (sleep disturbance, fatigue, fear of recurrence, quality of life) in rural, post-treatment cancer survivors in community oncology settings and to examine intervention costs. The resultant intervention will have great potential for widespread dissemination since it will be manualized, delivered by telephone, and comprised of modules to allow customized treatments for individuals with different cancer types.
详细描述
Noting the need for evidence-based cancer survivorship care, the American Society of Clinical Oncology (ASCO) published guidelines for screening, assessment, and care of psychosocial distress (anxiety, depression) in adults with cancer. These guidelines recommend screening all adults with cancer for distress and treating those with moderate or severe symptoms using a stepped-care approach tailored to distress severity. While these guidelines apply to survivors with all cancer types across the cancer treatment and survivorship continuum, we have chosen to focus on survivors with non-metastatic breast, colorectal, prostate, uterine, and cervical cancers , as well as those with any stage lymphoma (Hodgkin's or non-Hodgkin's). Further, we have focused on the post-treatment survivorship period 6 months-5 years post-treatment because distress may be more likely to be assessed and addressed after treatment completion. A significant minority of post-treatment survivors is at risk for anxiety and depression symptoms during the five years following the end of treatment and accessible interventions are needed to treat them.
The purpose of this study is to test a method of implementing this stepped-care approach in community oncology practices caring for cancer survivors, using self-directed and stepped-care telehealth approaches based on cognitive-behavioral theory. Our approach is based on a previous trial of telephone-based cognitive behavioral therapy for rural older adults with Generalized Anxiety Disorder (NIMH 1R01MH083664: The Tranquil Moments Study; PI: Brenes), which has demonstrated high acceptability and efficacy for reducing anxiety, worry, and depressive symptoms in a rural geriatric population. This protocol adapts the methods of the previous trial to bring psychosocial care to underserved cancer survivors, many of whom have minimal or no access to mental health providers. Cancer survivors will be recruited through multiple NCI Community Oncology Research Program (NCORP) sites through the NCI-funded Wake Forest NCORP Research Base (WF NCORP RB).
We will obtain data on feasibility, outcome variability, and efficacy for designing a subsequent fully powered randomized controlled trial (RCT) assessing the effects of the intervention on distress in cancer survivors. In the planned larger study, we anticipate that this intervention will: (a) reduce treatment barriers for post-treatment cancer survivors; (b) enhance availability of psychosocial treatment (through use of telephone sessions and a workbook); and (c) result in reductions in anxiety and depressive symptoms in cancer survivors.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Score ≥10 on the GAD-7 and/or a score ≥8 on the PHQ-9, indicating clinically significant anxiety or depressive symptoms, respectively.
- •Past history of treated Stage I, II, or III (newly diagnosed or recurrent) breast, colorectal, prostate, gynecologic (to include uterine and cervical) cancers and non-Hodgkin's lymphoma.
- •6-60 months post-treatment (surgery, chemotherapy, and/or radiation therapy) for cancer. Time frame applies to most recent completion of treatment if participant had a cancer recurrence. It is acceptable to be on maintenance or hormonal therapies.
- •Participant resides in California, Georgia, Illinois, Kansas, Michigan, Minnesota, Missouri, New Mexico, North Carolina, North Dakota, South Carolina, Virginia, Tennessee, or Wisconsin
- •Study-trained therapist in the state where the participant resides.
- •Must be able to speak and understand English.
- •Must have access to a telephone
排除标准
- •Current psychotherapy [regular appointment(s) with a psychologist, counselor, or therapist within the last 30 days prior to randomization].
- •Self-reported active alcohol or substance abuse within the last 30 days.
- •Past history of prostate cancer or non-Hodgkin's lymphoma with only active surveillance (i.e., no surgery, chemotherapy, or radiation therapy).
- •Diagnosis of a second malignancy (except for non-melanoma skin cancers) after a previous diagnosis of breast, colorectal, gynecologic cancers and non-Hodgkin's lymphoma
- •Progressive cancer (must be considered no evidence of disease or stable)
- •Self -reported history of a diagnosis of dementia from a healthcare provider.
- •Self -reported psychotic symptoms in the last 30 days prior to randomization
- •Active suicidal ideation (currently reported suicidal plan and intent).
- •Any change in psychotropic medications within the last 30 days.
- •Hearing loss that would preclude participating in telephone sessions (determined by brief hearing assessment administered by research staff)
- •Failure/inability/unwillingness to provide names and contact information for two family members or friends to serve as emergency contacts during the course of the study.
研究组 & 干预措施
Moderate Anxiety/depression: Low Intensity Stepped care
participants with moderate symptoms (PHQ-9-14; GAD-7: 10-14) will be randomized to either low-intensity stepped care or enhanced usual care. Stepped care consist of a self-guided cognitive behavioral therapy (CBT) workbook to reduce anxiety and depressive symptoms and biweekly (every two weeks) check-in calls from research staff to assess changes in symptom severity/immediate need for psychiatric treatment and provide minimal support.
干预措施: Moderate Anxiety/depression: Low Intensity Stepped care (Other)
Severe Anxiety/depression: High Intensity Stepped Care
Participants with severe symptoms (PHQ-9: 15-27; GAD-7: 15-21) will be randomized to high intensity stepped care (consist of a CBT workbook with accompanying psychotherapy by a Master's-level therapist delivered by telephone) or EUC. EUC consist of information about referrals/resources locally and nationally.
干预措施: Severe Anxiety/depression: High Intensity Stepped Care (Other)
Enhanced Usual Care Control (EUC)
Participants randomized to EUC will receive information about local referrals/resources (support groups, mental health providers, etc.). They will also be provided "Facing Forward: Life after Cancer Treatment," a book developed by the NCI to assist with transition from active treatment to survivorship. Participants will receive information on self-help workbooks for anxiety & depressive symptoms. EUC control will receive a copy of the CBT workbook on completion of the study.
干预措施: Enhanced Usual Care Control (Other)
结局指标
主要结局
Feasibility of Study Intervention Measured by Recruitment Rate
时间窗: Screening through end of study at week 13
Recruitment rate will be determined by the number of eligible participants who met all eligibility criteria and percent who agreed to participate.
Feasibility of Study Intervention Measured by Accrual Rate
时间窗: Start of study screening time to end of study accrual
The accrual rate is determined by dividing the overall number of participants recruited in each arm by the total span of 38 months between the start of the first screening for enrollment and the time the study closed to accrual.
Feasibility of Study Intervention Measured by Retention
时间窗: Randomization through completion of study at week 13
Study retention will be estimated by the number of participants who complete the Week 7 and 13 visits
Feasibility of Study Intervention Measured by Adherence to Intervention
时间窗: Randomization through completion of study at week 13
Intervention adherence will be estimated as the mean proportion of therapy (high-intensity intervention) or check-in (low-intensity intervention) sessions each participant completes.
次要结局
- Longitudinal Changes in the PROMIS Fatigue Scale From Baseline to 13 Weeks(Baseline (Week 0), Week 13)
- Number of Participants With Moderate of Severe Depression (PHQ-9) or Anxiety (GAD-7) at 13 Weeks(Week 13)
- Longitudinal Changes in the Fear of Recurrence Inventory Severity Subscale From Baseline to 13 Weeks(Baseline (Week 0), Week 13)
- Longitudinal Changes in the Generalized Anxiety Disorder (GAD)-7 Score for Anxiety From Baseline to 13 Weeks(Screening or baseline (if >30 days since screening), Week 13)
- Longitudinal Changes in the Patient Health Questionnaire (PHQ-9) Score for Depression From Baseline to 13 Weeks(Screening or baseline (if >30 days since screening), Week 13)
- Longitudinal Changes in the Insomnia Severity Index (ISI) From Baseline to 13 Weeks.(Baseline (Week 0), Week 13)
- Longitudinal Changes in the Health Status Questionnaire (SF-36) From Baseline to 13 Weeks(Baseline (Week 0), Week 13)
- Longitudinal Changes in the Impact of Events Scale-Revised (IES-R) From Baseline to 13 Weeks(Baseline (Week 0), Week 13)