Effectiveness of a Telephone-supported Depression Self-care Intervention for Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 2
- 主要终点
- Change in severity of depression symptoms: Centre for Epidemiologic Studies Depression Scale (CES-D)
研究概览
简要总结
Depressive symptoms are common in cancer survivors; 15% or more of cancer patients, even 1 year after diagnosis, experience depressive symptoms that can have a negative impact on their quality of life. Canadian care guidelines for cancer survivors recommend supporting the active engagement of survivors in their self-care.
This study is an evaluation of the effect of a depression self-care program which includes a self-care toolkit and support in the form of regular telephone calls from a self-care coach.
The toolkit contains tools that help cancer survivors:
- Learn new information to better understand depression. This can help people feel that they are not alone, and that their experience is not abnormal. Better understanding a condition also helps people feel more confident in their communications with health care professionals and can make it easier to share their experience with family and friends.
- Learn and practice new coping skills. This can help people feel confident that they can engage in the behaviours that have been shown to be beneficial for mood, e.g. restructuring thoughts, problem solving, and planning pleasant activities.
People eligible for the study are aged 18 and over, 1-10 years post-diagnosis, have completed primary cancer treatment (chemotherapy, radiation therapy or surgery) for any type of cancer, and have moderate depressive symptoms (as measured by a Patient Health Questionnaire (PHQ-9) score of 8-19). Recruitment will be conducted at cancer care centres in Montreal and at the Princess Margaret Cancer Centre in Toronto, and via community cancer support groups in Quebec and Ontario. Each participant enrolled in the study will receive the self-care toolkit (half will receive the toolkit and support calls at the start of the study, and half will receive the toolkit at the end), and will be followed for 6 months.
This proposed self-care program is innovative in its approach to the treatment of depression and has the potential to significantly improve the quality of life for Canadian cancer survivors with persistent depressive symptoms. The results of the study will determine whether the supported depression self-care program for cancer survivors is effective. The program is designed to be sustainable and widely applicable as it involves minimal costs, and the coaching can be delivered by telephone by volunteers in hospital and community settings. Investigators will work with clinical stakeholders and patient representatives to ensure that deliverables are relevant to the target population. Specific deliverables (in both French and English) include: a toolkit with a manual describing its use; a manual detailing coaching procedures; reports for decision makers and community cancer care groups; and short summaries for stakeholder groups.
详细描述
This pragmatic randomized controlled superiority trial aims to assess the effectiveness of a telephone-supported depression SCI in cancer survivors with moderate depressive symptoms when given in addition to usual care, in comparison to usual care only. Because of the pragmatic nature of this trial, members of both groups will continue to receive "usual care" for their depression, which may vary widely depending on local resources and medical practice. At each follow-up, participants are asked about specific treatment they have received for depression since entering the study (antidepressant medication initiation, discontinuation, change of dose, or psychotherapy) and their participation in community support groups and related activities; investigators will explore whether this care mediates the effects of the intervention. The study includes safeguards for participants who become suicidal or severely depressed during the study.
Research questions
Among cancer survivors in the post-treatment phase who have moderate to moderately-severe depressive symptoms [Patient Health Questionnaire (PHQ-9) score 8-19]:
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Primary research question: What is the effect of a telephone-supported depression self-care intervention (SCI) plus usual care compared to usual care only (control group CTL) on the primary outcome - severity of depression symptoms as measured by the Centre for Epidemiologic Studies Depression Scale (CES-D) 6 months after randomization? Hypothesis: Participants who receive the SCI will have better 6 month primary outcomes than those randomized to the Control group.
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Secondary questions:
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What are the effects of the SCI on: CES-D score at 3 months; depression diagnosis at 6 months; and mental health related quality of life, activation, severity of anxiety symptoms at 3 and 6 months, and use of health services over 6 months? Hypothesis: Participants who receive the SCI will have better health outcomes and lower use of health services than those randomized to the Control group.
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Are the effects of the SCI on the primary outcome modified by 5 primary baseline patient characteristics [major depression diagnosis; antidepressant medication; activation; recruitment source (clinical vs community); and level of education ] or by 9 secondary patient characteristics [cancer type, ongoing adjuvant cancer treatment (yes, no), years from cancer diagnosis (quartiles), severity of anxiety (as measured by the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A)), physical health-related quality of life (as measured by the Physical Component Summary (PCS) of the Short Form Health Survey (SF-12)) (quartiles), sex, age (quartiles), family support for self-management (quartiles), province of residence (Quebec, Ontario)].
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in severity of depression symptoms: Centre for Epidemiologic Studies Depression Scale (CES-D)
时间窗: Baseline, 3 months, 6 months
次要结局
- Change in severity of anxiety symptoms: Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-Anxiety)(Baseline, 3 months, 6 months)
- Change in mental and physical health-related quality of life: Short Form health survey (SF-12)(Baseline, 3 months, 6 months)
- Change in activation: Patient Activation Measure (PAM)(Baseline, 3 months, 6 months)
- Change in depression diagnosis: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders - IV Disorders (SCID)(Baseline, 6 months)
- Change in use of health services: self-report(Baseline, 3 month, 6 month)
研究者
Jane McCusker, MD DrPH
Professor Emerita and Full Professor Post-Retirement
McGill University
