Trial Outcomes & Findings for Information Consultation by Radiotherapy Manipulator (NCT NCT02867462)

Results Overview

Assesses the amount of information received by patients using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Information Module (EORTC QLQ-INFO25) before the first radiotherapy session. The Global Information Score will be reported. According to the EORTC scoring manual, raw scores are linearly transformed into a standardized scale ranging from a minimum of 0 to a maximum of 100. Higher values represent a better outcome (a higher level of information received), while lower values represent a worse outcome. Data will be presented as the mean value and standard deviation (SD) for each randomization arm.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

308 participants

Primary outcome timeframe

12 weeks

Results posted on

2026-06-30

Participant Flow

Participant milestones

Participant milestones
Measure	A-Standard Care standard care	B-manipulator Consultation Radiotherapy Added to Standard Care manipulator consultation radiotherapy added to standard care
Overall Study STARTED	154	154
Overall Study COMPLETED	150	150
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A-Standard Care n=150 Participants standard care	B-manipulator Consultation Radiotherapy Added to Standard Care n=150 Participants manipulator consultation radiotherapy added to standard care	Total n=300 Participants Total of all reporting groups
Age, Continuous	64.5 years n=150 Participants	63.8 years n=150 Participants	64.1 years n=300 Participants
Sex: Female, Male Female	86 Participants n=150 Participants	98 Participants n=150 Participants	184 Participants n=300 Participants
Sex: Female, Male Male	64 Participants n=150 Participants	52 Participants n=150 Participants	116 Participants n=300 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 12 weeks

Assesses the amount of information received by patients using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Information Module (EORTC QLQ-INFO25) before the first radiotherapy session. The Global Information Score will be reported. According to the EORTC scoring manual, raw scores are linearly transformed into a standardized scale ranging from a minimum of 0 to a maximum of 100. Higher values represent a better outcome (a higher level of information received), while lower values represent a worse outcome. Data will be presented as the mean value and standard deviation (SD) for each randomization arm.

Outcome measures

Outcome measures
Measure	B-manipulator Consultation Radiotherapy Added to Standard Care n=150 Participants manipulator consultation radiotherapy added to standard care	A-Standard Care n=150 Participants standard care
EORTC QLQ-INFO25	45.91 Score on a scale Standard Deviation 15.05	43.18 Score on a scale Standard Deviation 14.5

Adverse Events

A-Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B-manipulator Consultation Radiotherapy Added to Standard Care

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

Director of Clinical Trials

Centre Antoine Lacassagne

Phone: +33 4 92 03 10 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place