Trial Outcomes & Findings for Prospective Evaluation of the Impact on Patients' Quality of Life of a 12-Week Adapted Physical Activity Program (APA) (NCT NCT04675814)

Results Overview

Describe the evolution of the quality of life of patients being treated for their cancer pathology at the ICO site in Angers, and participating in the 12-week adapted physical activity program at ICO. Quality of life is measured with the FACIT-F Fatigue and Quality of Life Questionnaire. The questionnaire is structured into five sections, each containing between 6 and 13 items. In total, it includes 40 items, each scored from 0 to 4: 0 - Not at all 1. \- A little 2. \- Moderately 3. \- Quite a bit 4. \- Very much By adding up the answers, the score range obtained is: 0 to 160. The higher the score, the less tired the patient is.

Recruitment status

COMPLETED

Target enrollment

37 participants

Primary outcome timeframe

12 weeks

Results posted on

2026-01-27

Participant Flow

Study start date first signed consent: 14 SEP 2020 Date of first patient inclusion: 14 SEP 2020 End of trial date (last visit of last patient): 14 MAR 2021

All screened patients have been included

Participant milestones

Participant milestones
Measure	Adapted Physical Activity (APA) Adults participating in the APA program at ICO during the first semester of 2020, regardless of cancer type and ongoing treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy).
Overall Study STARTED	37
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Adapted Physical Activity (APA) Adults participating in the APA program at ICO during the first semester of 2020, regardless of cancer type and ongoing treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy).
Overall Study Withdrawal by Subject	3
Overall Study Performance status alteration not related to study procedure	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adapted Physical Activity (APA) n=37 Participants Adults participating in the APA program at ICO during the first semester of 2020, regardless of cancer type and ongoing treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy).
Age, Continuous	52.7 Years STANDARD_DEVIATION 11.5 • n=37 Participants
Sex: Female, Male Female	30 Participants n=37 Participants
Sex: Female, Male Male	7 Participants n=37 Participants
Region of Enrollment France	37 Participants n=37 Participants

PRIMARY outcome

Timeframe: 12 weeks

Describe the evolution of the quality of life of patients being treated for their cancer pathology at the ICO site in Angers, and participating in the 12-week adapted physical activity program at ICO. Quality of life is measured with the FACIT-F Fatigue and Quality of Life Questionnaire. The questionnaire is structured into five sections, each containing between 6 and 13 items. In total, it includes 40 items, each scored from 0 to 4: 0 - Not at all 1. \- A little 2. \- Moderately 3. \- Quite a bit 4. \- Very much By adding up the answers, the score range obtained is: 0 to 160. The higher the score, the less tired the patient is.

Outcome measures

Outcome measures
Measure	Adapted Physical Activity (APA) n=33 Participants Adults participating in the APA program at ICO during the first semester of 2020, regardless of cancer type and ongoing treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy).
Quality of Life of Patients Participating in the 12-week Adapted Physical Activity Program.	117.6 score on a scale Standard Deviation 23.5

SECONDARY outcome

Timeframe: 12 weeks

The number of sessions is planned by the APA coach at the beginning of the APA program. The number of performed sessions is measured.

Outcome measures

Outcome measures
Measure	Adapted Physical Activity (APA) n=37 Participants Adults participating in the APA program at ICO during the first semester of 2020, regardless of cancer type and ongoing treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy).
Describe Attendance at the APA Program.	14.2 Number of APA sessions Standard Deviation 6.3

SECONDARY outcome

Timeframe: 12 weeks

Kinesiophobia is measured with the TAMPA Scale for Kinesiophobia (TSK-CF). This scale assesses the kinesiophobia index presented by the patient at the time of the assessment. The higher the score, the greater the level of kinesiophobia. Total score range: 17 to 68. Higher scores indicate greater fear of movement. A score ≥ 40 is considered significant kinesiophobia.

Outcome measures

Outcome measures
Measure	Adapted Physical Activity (APA) n=33 Participants Adults participating in the APA program at ICO during the first semester of 2020, regardless of cancer type and ongoing treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy).
Measure the Evolution of Kinesiophobia (Fear of Movement).	34.45 score on a scale Standard Deviation 6.02

SECONDARY outcome

Timeframe: Week 0

The level of physical activity (PA) is assessed using the GPAQ questionnaire. The questionnaire consists of 16 items. Physical activity is expressed in MET-minutes per week (Metabolic Equivalent of Task), calculated from reported activity. Based on the score, three profiles are defined: High * ≥3 days vigorous activity (≥1500 MET-min/week) OR * ≥7 days walking/moderate/vigorous PA (≥3000 MET-min/week) Moderate * ≥20 min vigorous PA / day, ≥3 days/week OR * ≥30 min moderate PA/walking / day, ≥5 days/week OR * ≥5 days mixed activity (≥600 MET-min/week) Low * Does not meet above criteria

Outcome measures

Outcome measures
Measure	Adapted Physical Activity (APA) n=37 Participants Adults participating in the APA program at ICO during the first semester of 2020, regardless of cancer type and ongoing treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy).
Measure Physical Activity at the Initiation of the APA Program. High activity level	1 Participants
Measure Physical Activity at the Initiation of the APA Program. Moderate activity level	19 Participants
Measure Physical Activity at the Initiation of the APA Program. Low activity level	17 Participants

Adverse Events

Adapted Physical Activity (APA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr ABADIE-LACOURTOISIE Sophie

Institut de Cancérologie de l'Ouest

Phone: +33 2 41 35 27 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place