Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors With Clinically Significant Psychiatric Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility 4: Adherence to the treatment protocol #2
研究概览
简要总结
Negative psychological effects of cancer are common, but cancer survivors are rarely offered structured psychological treatment. Internet-delivered treatments have shown some promise, but specific treatment components have not been empirically evaluated which means that it is not clear which therapies that should be prioritized. In this factorial pilot study, 48 cancer survivors with psychiatric symptoms are enrolled in variations on a 10-week therapist-guided online psychological treatment intended to address common negative psychological long-term effects of cancer. The aim of this study is to assess the feasibility of the study design and online treatment format. Key feasibility outcomes include interest in the study, patient-reported credibility of the intervention, adherence to the treatment protocol, satisfaction with the treatment, acceptability of the measurement strategy, missing data rates, adverse events, and preliminary efficacy on anxiety, depression, the fear of recurrence, and health-related quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Cancer survivor at least 0.5 years after main therapy. Survivor of breast cancer (n=24), testicular cancer (n=12), or thyroid cancer (n=12).
- •Clinically significant anxiety or depression (Patient Health Questionnaire 9 [PHQ-9]≥10, or Generalized Anxiety Disorder 7 [GAD-7]≥8, or 9-item Fear of Cancer Recurrence Inventory [FCRI-9]≥16)
- •At least 18 years old
- •Resident of Sweden (listed and de facto)
- •Sufficient technical knowledge and knowledge of the Swedish language to take part in a text-based online treatment
- •Continuous access to an electronic device that can be used to access the study web platform
排除标准
- •Recurrent thoughts of suicide, as based on clinical judgement aided by the structured interview and the self-report version of the Montgomery-Åsberg Depression Rating Scale (MADRS-S) item 9
- •Severe medical condition (e.g., very poor prognosis, stage IV cancer), severe psychiatric disorder (e.g., psychotic disorder, bipolar disorder, or severely debilitating substance use disorder, severe depression), or medical treatment (e.g., chemotherapy, immunotherapy, radiotherapy) that makes the treatment unfeasible
- •Other ongoing psychological treatment
- •Continuous psychotropic medication not stable for the past 4 weeks, or not expected to remain stable during the treatment period
- •Planned absence for more than one week of the intended treatment period
- •No complete the pre-treatment assessment
结局指标
主要结局
Feasibility 4: Adherence to the treatment protocol #2
时间窗: Each week from the beginning of treatment to the post-treatment assessment (immediately after treatment, completed within 45 days)
Number of completed exercises, as based on a short weekly questionnaire tailored to suit each treatment arm, with corresponding questions about the number of days devoted to exposure exercises, days devoted to activity planning, and days devoted to the promotion of health behaviors.
Feasibility 1: Feasibility of the randomized factorial design
时间窗: Post-treatment assessment (immediately after treatment, completed within 45 days)
A key feasibility outcome of this pilot study is the overall experience of study administrators and therapists tasked with the assignment and delivery of treatment variants in accordance with the randomized factorial design. After the main phase, all study administrators and therapists will be asked to rate the feasibility of the planned study design from 0 ("not feasible at all") to 10 ("fully feasible"), which will reported as a mean (SD) and median.
Feasibility 7: Patients' satisfaction with the treatment #1
时间窗: Post-treatment assessment (within 45 days after treatment)
The 8-item Client Satisfaction Questionnaire (CSQ-8). Theoretical range: 8-32, where a higher score indicates higher satisfaction.
Feasibility 10: Rate of adverse events and negative experiences #2
时间窗: Post-treatment assessment (within 45 days after treatment)
20-item Negative Effects Questionnaire (NEQ-20). This will be reported as the proportion of endorsed items in the following subdomains: increase in symptoms, perceived insufficient quality of treatment, dependency, stigma, and hopelessness.
Feasibility 2: Credibility of the treatment as perceived by patients
时间窗: Week 2 of treatment
Credibility/Expectancy scale (C/E scale). Theoretical range: 0-50, where a higher score indicates higher credibility/expectancy.
Feasibility 11: Preliminary efficacy in terms of within-group average change in general anxiety
时间窗: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
General Anxiety Disorder 7 (GAD-7, theoretical range: 0-21, where a higher score indicates more general anxiety)
Feasibility 12: Preliminary efficacy in terms of within-group average change in depressive symptoms
时间窗: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, where a higher score indicates more symptoms of depression)
Feasibility 13: Preliminary efficacy in terms of within-group improvement in the fear of cancer recurrence
时间窗: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
9-item Fear of Cancer Recurrence Inventory (FCRI-9, theoretical range: 0-36, where a higher score indicates a more pronounced fear of cancer recurrence)
Feasibility 3: Adherence to the treatment protocol #1
时间窗: Over the 10-week treatment period, with registration at the post-treatment assessment (immediately after treatment).
Number of modules initiated, as registered by the clinician.
Feasibility 5: Acceptability of the online measurement strategy #1
时间窗: Each week from the Each week from the beginning of treatment to the follow-up assessment (3 months after treatment)
Number of measurements completed at each measurement point after the pre-treatment assessment. Preregistered target: at least 70% non-missing at the post-treatment and follow-up assessments.
Feasibility 8: Patients' satisfaction with the treatment #2
时间窗: Post-treatment assessment (within 45 days after treatment)
Likert items pertaining to satisfaction with components.
Feasibility 14: Preliminary efficacy in terms of within-group improvement in health-related quality of life
时间窗: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
36-item Short Form Health Survey (SF-36, scored as a Mental Health Component Score and a Physical Health Component Score according to standard norms, both with a theoretical range of 0-100, where a higher score indicates a higher health-related quality of life)
Feasibility 6: Acceptability of the online measurement strategy #2
时间窗: Post-treatment assessment (within 45 days after treatment)
Perceived strain caused by the measurement strategy. Preregistered target: at least 75% with a rating below 7 from 0 ("not at all stressful/distressing") to 10 ("extremely stressful/distressing").
Feasibility 9: Rate of adverse events and negative experiences #1
时间窗: Post-treatment assessment (within 45 days after treatment)
Questionnaire used in previous clinical trials (e.g., ClinicalTrials.gov: NCT04511286)
次要结局
- Symptom domains surveyed primarily to assess the feasibility of the measurement method: Somatic symptom burden.(Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days). Secondary analysis: from pre-treatment up to follow-up 3 months after treatment.)
- Screening only: Alcohol use(At screening)
- Symptom domains surveyed primarily to assess the feasibility of the measurement method: Health anxiety.(Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days). Secondary analysis: from pre-treatment up to follow-up 3 months after treatment.)
- Symptom domains surveyed primarily to assess the feasibility of the measurement method: Body image distress.(Screening (within 6 months before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days).)
- Symptom domains surveyed primarily to assess the feasibility of the measurement method: Disability.(Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days). Secondary analysis: from pre-treatment up to follow-up 3 months after treatment.)
- Process and target variables surveyed primarily to assess the feasibility of the measurement method: Physical activity(Pre-treatment (within 2 weeks before treatment), once each week during treatment (9 assessments in total), post-treatment (after treatment, completed within 45 days), and at follow-up 3 months after treatment (completed within 45 days).)
- Screening only: General distress(At screening)
- Screening only: Substance use(At screening)
- Process and target variables surveyed primarily to assess the feasibility of the measurement method: Behavioral activation(Pre-treatment (within 2 weeks before treatment), once each week during treatment (9 assessments in total), post-treatment (after treatment, completed within 45 days), and at follow-up 3 months after treatment (completed within 45 days).)
- Process and target variables surveyed primarily to assess the feasibility of the measurement method: Symptom preoccupation(Pre-treatment (within 2 weeks before treatment), once each week during treatment (9 assessments in total), post-treatment (after treatment, completed within 45 days), and at follow-up 3 months after treatment (completed within 45 days).)
- Process and target variables surveyed primarily to assess the feasibility of the measurement method: Health-related self-efficacy.(Pre-treatment (within 2 weeks before treatment), once each week during treatment (9 assessments in total), post-treatment (after treatment, completed within 45 days), and at follow-up 3 months after treatment (completed within 45 days).)
- Relationship with the therapist (therapeutic alliance)(Week 2 of treatment)
研究者
Erland Axelsson
Principal Investigator
Karolinska Institutet