Cancer
Conditions
Brief summary
The medical teams are increasingly sought by patients to get the most possible information, probably expressed in a different form and thereby supplementing the information already received. Coulter et al. reached similar conclusions in their study of the writings of patient information documents. They point out, moreover, the best adaptation of the patients better informed compared to those with less or no information. This need for information varies over time. It is present before treatment begins, continues during treatment and persists after treatment. Given the specific features of radiotherapy, the manipulators are important interlocutors to participate in the accompanying caregiver time. In conclusion, the quality of information delivered to the patient has been poorly evaluated, let alone with validated tools in this area. The impact of information on the tolerance of the treatment also needs to be confirmed, knowing that an informed patient seems less anxious and better prepared for future treatment.
Interventions
OTHERStandard care
standard care
OTHERmanipulator consultation radiotherapy added to standard care
Sponsors
Centre Antoine Lacassagne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with cancer of the head and neck, esophagus, stomach, breast, rectum, anal canal, prostate, lung, bile duct, pancreas or female genital histologically proven * Patient being treated by radiotherapy alone or combined with chemotherapy / immunotherapy, exclusive treatment or adjuvant * Age over 18 years
Exclusion criteria
* Patient has been treated with radiation to the tumor site * Patient with metastatic stage disease * Patient targeted for hypofractionated radiotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EORTC QLQ-INFO25 | 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORKaren BENEZERY, md
Centre Antoine Lacassagne
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.1 years |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 86 Participants |
| Sex: Female, Male Male | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 0 / 150 |
| other Total, other adverse events | 0 / 150 | 0 / 150 |
| serious Total, serious adverse events | 0 / 150 | 0 / 150 |
Outcome results
None listed