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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Between inclusion and 3 months

Results posted on

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

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

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 months

Population: 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

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 inclusion

Population: 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

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 months

Population: 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

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 events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

François Christy

Centre François Baclesse

Phone: 0231450002

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place