Cancer and Aging Reflections for Elders (CARE): A Geriatric-Specific Psychotherapy for Older Adults With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 459
- 试验地点
- 1
- 主要终点
- Depression and Anxiety: Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
This study is being done to see if a new psychotherapy intervention called Cancer and Aging: Reflections for Elders (CARE) can effectively treat depression and distress in older cancer patients. CARE is a 5-session intervention that takes place over the phone. This study will compare CARE with the Social Work and Supportive Counseling (SWSC) intervention, which also takes place over the phone. SWSC is a standard psychotherapeutic intervention that has been shown to be a supportive and effective form of treatment for distress for patients with cancer. The researchers will look at which intervention is more effective in treating depression and distress in participants.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •As per self-report or medical record, ≥ 70 years of age
- •As per self-report or medical record, has a diagnosis of cancer
- •As per self-report or medical record, receiving active treatment (e.g., radiation, chemotherapy, hormone); OR received active treatment in the past 6 months (N/A for training case participants); OR are currently on active surveillance with follow-ups at least approximately every 6 months
- •Received a HADS-D score of ≥ 6 or HADS-A score of ≥ 6 or a score of ≥ 4 on the distress thermometer. (N/A for training case participants)
- •Received a Karnofsky Performance Rating Scale (KPRS) score of ≥ 60 (N/A for training case participants)
- •Received a Blessed Orientation-Memory-Concentration Scale (BOMC) score of ≤ 11 (N/A for training case participants)
- •Fluent in English, as per self-reported fluency of "well" or "very well"*
排除标准
- •As per self-report, currently taking antidepressant medication for < 3 months
- •As per self-report, currently receiving hospice care
- •In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment
- •As per self-report or as documented in the medical record, current untreated (e.g., no medication, no therapy) major psychotic disorder (schizotypal personality disorder, schizophreniform disorder, schizoaffective disorder). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility prior to consent.
- •Language verification: Prior to enrollment, patients will be asked the following two questions by research staff to verify English fluency necessary for participation in the study:
- •How well do you speak English? (must respond "Well" or "Very well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
- •What is your preferred language for healthcare? (must respond English)
研究组 & 干预措施
Social Work and Supportive Counseling (SWSC)
The SWSC will include a social work assessment and follow-up augmented with additional components of supportive psychotherapy that have been shown to be an effective form of treatment for patients with cancer. Five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months).
干预措施: Social Work and Supportive Counseling (SWSC) Intervention (Behavioral)
Cancer and Aging: Reflections for Elders (CARE) Intervention
Session content and timing was developed and confirmed in our qualitative work (Expert Panel) and the CARE pilot study. Five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months).
干预措施: Cancer and Aging: Reflections for Elders (CARE) Intervention (Behavioral)
结局指标
主要结局
Depression and Anxiety: Hospital Anxiety and Depression Scale (HADS)
时间窗: 9 months
This 14-item scale, which has been well tested in cancer populations including elderly patients with cancer, has depression and anxiety subscales of seven items each. It is considered particularly useful for patients with chronic disease because of the absence of somatic items that often confound the determination of psychiatric problems among the medically ill.
次要结局
未报告次要终点