Trial Outcomes & Findings for Management of Cognitive Difficulties After Cancer Treatments in Women Treated for Breast Cancer: Feasibility Study (Step 1 of the Cog-Stim Protocol) (NCT NCT04213365)
NCT ID: NCT04213365
Last Updated: 2026-07-02
Results Overview
The proportion of patients who will realize cognitive stimulation sessions coupled with sessions of adapted physical activity. A session of either cognitive or physical training was considered performed if at least 70% of the session was completed (≥ 14/20 min of cognitive session, and 20/30 min of APA session). For each week of the intervention, adherence was considered to be achieved if all four planned sessions were completed. High adherence to the 12-week multimodal intervention was defined as completing at least 9 weeks of the program.
COMPLETED
NA
20 participants
Between inclusion and 3 months
2026-07-02
Participant Flow
Eligible patients were women with localized breast cancer who were starting or currently undergoing adjuvant radiotherapy, with or without prior adjuvant chemotherapy, who had not yet initiated hormone therapy, were older than 18 years, and reported cognitive complaints with a significant impact on their quality of life.
Participant milestones
| Measure |
Cognitive Stimulation and Adapted Physical Activity
12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
All included patients were described at baseline.
Baseline characteristics by cohort
| Measure |
Cognitive Stimulation and Adapted Physical Activity
n=20 Participants
12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions.
|
|---|---|
|
Age, Continuous
|
48.5 Years
n=20 Participants • All included patients were described at baseline.
|
|
Sex: Female, Male
Female
|
20 Participants
n=20 Participants • All included patients were described at baseline.
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants • All included patients were described at baseline.
|
PRIMARY outcome
Timeframe: Between inclusion and 3 monthsPopulation: All included patients were analysed for the primary endpoint.
The proportion of patients who will realize cognitive stimulation sessions coupled with sessions of adapted physical activity. A session of either cognitive or physical training was considered performed if at least 70% of the session was completed (≥ 14/20 min of cognitive session, and 20/30 min of APA session). For each week of the intervention, adherence was considered to be achieved if all four planned sessions were completed. High adherence to the 12-week multimodal intervention was defined as completing at least 9 weeks of the program.
Outcome measures
| Measure |
Cognitive Stimulation and Adapted Physical Activity
n=20 Participants
12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions.
|
|---|---|
|
Patient Adherence
|
11 Participants
|
SECONDARY outcome
Timeframe: Before inclusionPopulation: Fifty-four of the eligible patients were contacted to assess their willingness to participate in the study.
Proportion of patient who accept the participation in the study
Outcome measures
| Measure |
Cognitive Stimulation and Adapted Physical Activity
n=54 Participants
12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions.
|
|---|---|
|
Proportion of Acceptance
|
20 Participants
|
SECONDARY outcome
Timeframe: Between inclusion and 3 monthsPopulation: Five patients did not complete the satisfaction questionnaire.
Satisfaction questionnary (Patient satisfaction questionnaire; range 0:5 by question, 15 questions, total score range : 0-100) - The higher the scores, the better the satisfaction.
Outcome measures
| Measure |
Cognitive Stimulation and Adapted Physical Activity
n=15 Participants
12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions.
|
|---|---|
|
Patient Satisfaction
|
89.2 Score between 0 and 100
Standard Deviation 7.52
|
Adverse Events
Cognitive Stimulation and Adapted Physical Activity
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cognitive Stimulation and Adapted Physical Activity
n=20 participants at risk
12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions.
|
|---|---|
|
Injury, poisoning and procedural complications
Fall with T11-T12 vertebral compression fracture
|
5.0%
1/20 • Number of events 1 • 3 months
|
|
Infections and infestations
Axillary abscess drainage
|
5.0%
1/20 • Number of events 1 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place