CanCOG®: Pilot Trial of Cognitive Rehabilitation for Cancer Survivors

Condition(s) studied

Investigational drug(s) / intervention(s)

CanCOG® - Cogntive Rehabilitation in Cancer: CanCOG® is a structured cognitive rehabilitation program designed for cancer survivors experiencing cancer-related cognitive impairment (CRCI). The intervention is delivered in person in small groups of 3 to 9 participants by a trained professional and consists of six weekly sessions of 90 minutes each over six consecutive weeks. The program combines psychoeducation about CRCI, cognitive training exercises targeting domains such as attention, memory, and executive functioning, and compensatory strategy training to support everyday cognitive functioning and self-management of cognitive difficulties.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Feasibility - Screening rate — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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.

Trial sites (1)

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