Randomized Controlled Trial of the Meaning-Making Intervention (MMi) in Patients Newly Diagnosed With Advanced Cancer: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Feasibility
研究概览
简要总结
Research questions: Pilot study research questions: Primary: 1)Can we recruit a sufficient number (i.e., at least 60 patients over 9 months) and retain a sufficient proportion of both men and women (i.e., at least 80% at 2, 4, or 6 months post-randomization) with advanced cancer in all 3 trial arms to allow completion of a full study in 4 years?; 2)Is MMi acceptable: to a general ACP? to both men and women?; Secondary: 1)Is it feasible to complete the intervention in 3-4 weeks? 2)How long is it feasible to test MMi effects: 2, 4 or 6 months post-randomization(retention rate=80%)? 3)Which recruitment strategies are most helpful? 4)What sample size is needed for a full study? Full-study research questions: Primary: Does adding the MMi to usual care (experimental group or EG) enhance meaning in life among newly diagnosed ACP, compared with those receiving usual care plus meetings with an empathic non-professional visitor (i.e., attention-control group or AC) or usual care alone (UC), at x months post-randomization? (time determined in pilot) "Meaning in life" (primary outcome) is defined as the belief that one's life has significance and purpose (i.e., global meaning) and "newly diagnosed ACP" is defined as the 6 months after first occurrence of, progression toward, or recurrence of stage III or IV cancer (TNM classification system). Secondary: In our future full-study, we plan to evaluate MMi effects on secondary outcomes such as existential wellbeing (MQOL existential wellbeing) and posttraumatic growth (Post-Traumatic Growth Inventory). We also plan to test a theoretical model where sense of meaning in life has a protective (moderating) effect on tertiary outcomes such as physical QoL (MQOL physical subscale), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), and overall QoL (MQOL Total) in EG patients. Methodology: RCT pilot study with 60 newly diagnosed ACP (stages III or IV) within 2 months of referral and 6 months of randomization, assigned randomly to: (1) EG, (2) AC, or (3) UC. Patients will complete self-report questionnaires (including outcome measures, as well as sociodemographic and medical variables) at 2, 4 and 6 months post-randomization.
详细描述
See above
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with advanced cancer (stage III or IV --TNM classification system; 117); first occurrence, progression or recurrence) of any type of solid tumour <2 months at referral and <6 months at randomization. 2) Willing to participate in weekly MMi or AC sessions. 3) >18 years. 4) Alert and capable of giving free and informed consent. 5) Able to speak and read English or French.
排除标准
- •Karnofsky Performance Status (KPS) score <60 (rated by referring oncologists/nurses or Research Coordinator (RC)) or expected survival <6 months according to clinical judgment. 2) Currently receiving radiotherapy (Rx) treatment (although these patients can be reassessed after Rx). Patients will only be included in the study when they have recovered from severe side-effects from Rx and when they feel they can participate in the study. Severe side-effects are defined as a score of 3 or 4 on any of the site-specific toxicity markers of the Eastern Cooperative Oncology Group (ECOG) Common Toxicity Criteria or with more than 3 markers with a score of 2 (moderate side-effects), as evaluated by the treating physician (in consultation with the radiotherapist. 3) Suicidal. Present a score of ≥2 on the Beck Depression Inventory (BDI) suicide item (item #9), administered by the RC or RA during the consent meeting. 4) Known diagnosis of schizophrenia or schizoaffective disorder. 5) Planning a trip within 2 months that would interrupt delivery of the MMi or AC.
结局指标
主要结局
Feasibility
时间窗: 2 months post randomization
1. Can we recruit a sufficient number (i.e., 60 patients over 9 months or 6.7 per month) of newly diagnosed advanced cancer patients? AND 2. Can we retain a sufficient proportion of both men and women (i.e., at least 80%) with advanced cancer in all 3 trial arms to allow completion of a full study in 4 years?
Acceptability
时间窗: 2 months post-randomization
Is the MMi acceptable to at least 80% of men and women with advanced cancer, as indicated by 80% positive responses on the Pilot-Study Questionnaire (PSQ; adapted from the CSQ-8; Attkisson \& Zwick, 1982) Q#7 (score 3 or 4), Q#8, and Q#9 (score 5, 6 or 7). PSQ Q#7: Would you recommend those types of meetings to other people in your situation? 1= no, definitively not; 2= no, I don't think so; 3= yes, I think so; 4= yes, definitively PSQ Q#8: Were the meetings acceptable? PSQ Q#9: On the whole, how positive or negative was your experience of the meetings? 1= Totally negative; 2= Very negative; 3= A little negative; 4= Neutral; 5= A little positive; 6= Very positive; 7= Totally positive
次要结局
- Sample size calculation for the full study(2 months post-randomization)
- Recruitment strategies(2 months post-randomization)
- Primary evaluation time(6 months post-randomization)
- Timing of the intervention(2 month post-randomization)
研究者
Melissa Henry
Psychologist
Jewish General Hospital