CanCOG® - Cognitive Rehabilitation in Cancer: A Protocol for a Multicenter Pilot Randomized Controlled Trial With Non-central Nervous System Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility - Screening rate
研究概览
简要总结
Cancer-related cognitive impairment (CRCI) affects a large proportion of non-central nervous system cancer survivors and can negatively impact cognitive functioning and daily life. Cognitive rehabilitation has shown promising results in addressing these difficulties. The goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and preliminary efficacy of the CanCOG®- Cognitive Rehabilitation in Cancer program in Portuguese adult cancer survivors with CRCI.
Adult non-central nervous system cancer survivors (n=60) will be randomly assigned to receive either the CanCOG® intervention or treatment as usual.
CanCOG® is a structured cognitive rehabilitation program designed to help cancer survivors manage cognitive difficulties through cognitive training exercises, psychoeducation, and compensatory strategy training. The program consists of six weekly sessions of 1 hour and 30 minutes each, delivered over six consecutive weeks. Sessions are administered in person in small groups (3-9 participants) and are led by a trained professional.
The main focus of the study is to assess feasibility outcomes, including recruitment, retention, adherence to the intervention, and completion of study assessments, as well as acceptability and participant satisfaction.
The study will also explore preliminary effects of the intervention on cognitive functioning (both perceived and objective), symptoms of anxiety and depression, and quality of life. Participants will complete assessments at baseline (2 weeks after the intervention), 2 weeks after the intervention, and at 3- and 6-month follow-ups. Some participants (10-15) will also take part in interviews to provide feedback on their experience with the program.
详细描述
Cancer-related cognitive impairment (CRCI) is a frequent consequence of cancer and its treatments in non-central nervous system survivors and has been associated with persistent difficulties in multiple cognitive domains, including attention, memory, and executive functioning.
Cognitive rehabilitation approaches aim to improve cognitive functioning and promote the use of compensatory strategies to support daily functioning in individuals experiencing CRCI. The CanCOG® program is a structured group-based cognitive rehabilitation intervention delivered by trained professionals and incorporating cognitive training exercises, psychoeducation, and strategy training.
This study is a pilot randomized controlled trial designed to inform the feasibility and acceptability of the intervention and study procedures, as well as to provide preliminary evidence regarding potential intervention effects.
The intervention consists of six weekly in-person group sessions (1 hour and 30 minutes each), delivered over six consecutive weeks in small groups of 3 to 9 participants.
Outcomes will be assessed using a comprehensive neuropsychological and psychosocial evaluation battery covering global cognition, memory, attention, executive functioning, psychological distress, and quality of life, using validated instruments. Assessments will be conducted at baseline, post-intervention, and at 3- and 6-month follow-up time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65 years whose native language is European Portuguese;
- •Diagnosis of cancer not involving the central nervous system (non-CNS cancer);
- •Disease stage I to III;
- •Completion of primary cancer treatment at least 6 months and no more than 5 years prior to enrollment (with the exception of ongoing hormone therapy and immunotherapy);
- •Score < 51 on the Perceived Cognitive Abilities subscale of the FACT-Cog v
- •Stable psychiatric and neurological medication regimen for at least 3 months prior to enrollment;
- •Educational level equal to or higher than the 3rd year of primary education;
- •Ability to read and write in Portuguese and provide informed consent to participate.
排除标准
- •Diagnosis of current severe psychiatric disorders (e.g., schizophrenia, psychosis, bipolar disorder, major depressive disorder, or attention-deficit/hyperactivity disorder);
- •Diagnosis of communication disorders;
- •Diagnosis of neurodevelopmental disorders or other severe medical conditions (e.g., history of stroke, encephalitis, dementia or neurodegenerative disease, epilepsy, or traumatic brain injury);
- •Presence of metastases or other tumors;
- •History of substance abuse (alcohol or drugs);
- •Current or prior participation in another cognitive rehabilitation intervention.
研究组 & 干预措施
Cognitive rehabilitation intervention
Participants allocated to this arm will receive the CanCOG® cognitive rehabilitation intervention in addition to usual care. Following baseline assessment (2 weeks before the intervention), participants will attend the intervention over a 6-week period and complete study assessments 2 weeks after the intervention and at 3- and 6-month follow-up time points. Participants will be asked to complete neuropsychological and psychosocial assessments at each evaluation point. A subset of participants (10-15) may also be invited to participate in a semi-structured interview to explore the acceptability of the intervention, perceived benefits, barriers to participation, and overall satisfaction with the program and study procedures.
干预措施: CanCOG® - Cogntive Rehabilitation in Cancer (Behavioral)
Treatment-as-usual
Participants allocated to this arm will continue to receive the usual care and support available through their healthcare providers and will not receive the CanCOG® intervention during the study period. Participants will complete the same schedule of neuropsychological and psychosocial assessments as the intervention group at baseline, post-intervention, and at 3- and 6-month follow-up time points.
结局指标
主要结局
Feasibility - Screening rate
时间窗: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups.
Screening rate will be assessed as the proportion of potentially eligible cancer survivors who undergo eligibility screening.
Feasibility - Eligibility rate
时间窗: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups
The eligibility rate will be assessed as the proportion of screened individuals who meet the eligibility criteria. Reasons for ineligibility will be documented whenever available.
Feasibility - Consent rate
时间窗: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups.
Consent rate will be assessed as the proportion of eligible individuals who provide informed consent. Reasons for refusal to participate will be documented whenever available.
Feasibility - Retention rate
时间窗: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups
Retention rate will be assessed as the proportion of participants who remain enrolled until study completion. Reasons for withdrawal will be documented whenever available.
Feasibility - Assesment completion rate
时间窗: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups
Assessment completion rate will be assessed as the proportion of participants completing assessments at each assessment time point. Reasons for missed assessments will be documented whenever available.
Feasibility - Intervention adherence
时间窗: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups
Intervention adherence will be assessed as the proportion of intervention sessions attended by participants allocated to the intervention group. Reasons for missed sessions will be documented whenever available.
Feasibility - Intervention fidelity
时间窗: Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups
Intervention fidelity, the extent to which the intervention is delivered according to the intervention manual and session plans, will be assessed through facilitator-completed fidelity checklists.
Acceptability - Participant retention and intervention adherence
时间窗: Baseline ( 2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.
Acceptability of the intervention will be assessed using participant retention (proportion of participants who remain enrolled until study completion) and intervention adherence (proportion of intervention sessions attended by participants allocated to the intervention group).
Acceptability - Qualitative feedback
时间窗: Post-intervention (2 weeks after)
Acceptability will be assessed through semi-structured interviews conducted with 10-15 participants from the intervention group. Interviews will explore participants' perceptions of the intervention content, format, duration, group delivery, perceived usefulness, and barriers or facilitators to participation.
Acceptability - ACRIS-CS
时间窗: Baseline (2 weeks before intervention) and post-intervention (2 weeks after).
Acceptability will also be assessed through the Acceptability of Cognitive Rehabilitation Interventions Survey-Cancer Survivors (ACRIS-CS). This 11-item instrument evaluates participants' perceptions of the intervention's acceptability, including its perceived usefulness, appropriateness, and overall satisfaction. Higher scores indicate greater acceptability of the cognitive rehabilitation intervention.
次要结局
- Perceived cognitive functioning(Baseline (2 weeks before intervention), post-intervention (2weeks after), 3-month and 6-month follow-ups.)
- Objective cognitive functioning (Global cognition)(Baseline (2 weeks before intervention), Post-intervention (2 weeks after), and 3-month and 6-month follow-up.)
- Objective cognitive functioning (Verbal learning and memory)(Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.)
- Objective cognitive functioning (Attention and processing speed)(Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.)
- Objective cognitive functioning (Executive functioning and cognitive flexibility)(Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.)
- Objective cognitive functioning (Working memory)(Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.)
- Objective cognitive functioning (Verbal fluency)(Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.)
- Objective cognitive functioning (Inhibitory control)(Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.)
- Anxiety Symptoms(Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-ups.)
- Depressive Symptoms(Baseline (2 weeks before intervention) , post-intervention (2 weeks after), and 3-month and 6-month follow-up.)
- Health-related quality of life(Baseline (2 weeks before intervention), post-intervention (2 weeks after), and 3-month and 6-month follow-up.)
研究者
Sofia Alexandra Marques Fernandes
Principal Investigator
Aveiro University