Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
General patient-, disease-, and treatment-related information |
General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, radiotherapy regime. |
Baseline |
|
Other |
General patient-, disease-, and treatment-related information |
General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, radiotherapy regime. |
Week 4 of radiotherapy |
|
Other |
General patient-, disease-, and treatment-related information |
General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, radiotherapy regime. |
Two weeks post-radiotherapy (follow-up) |
|
Primary |
Skin reaction evaluation |
The patients skin reactions will be evaluated by the modified version of the RTOG criteria |
Baseline |
|
Primary |
Skin reaction evaluation |
The patients skin reactions will be evaluated by the modified version of the RTOG criteria |
At fraction 15-16 of radiotherapy (week 3 ) |
|
Primary |
Skin reaction evaluation |
The patients skin reactions will be evaluated by the modified version of the RTOG criteria |
At fraction 20-21 of radiotherapy (week 4) in case of a tumor boost |
|
Secondary |
Patient subjective evaluation of skin reactions |
The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale |
Baseline |
|
Secondary |
Patient subjective evaluation of skin reactions |
The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale |
Week 1 of radiotherapy |
|
Secondary |
Patient subjective evaluation of skin reactions |
The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale |
Week 2 of radiotherapy |
|
Secondary |
Patient subjective evaluation of skin reactions |
The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale |
At fraction 15/16 of radiotherapy (week 3) |
|
Secondary |
Patient subjective evaluation of skin reactions |
The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale |
At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost |
|
Secondary |
Quality of life assessment |
The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items). |
Baseline |
|
Secondary |
Quality of life assessment |
The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items). |
At fraction 15/16 of radiotherapy (week 3) |
|
Secondary |
Quality of life assessment |
The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items). |
At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost |
|
Secondary |
Patients' satisfaction with the therapeutic intervention |
The patients will be asked to evaluate the general pleasantness and soothing effect of the skin care products. Furthermore, they will be asked to score their global satisfaction with the skin care products. All these items will be evaluated by using a numerical rating scale (NRS). |
At fraction 15/16 of radiotherapy (week 3) |
|
Secondary |
Patients' satisfaction with the therapeutic intervention |
The patients will be asked to evaluate the general pleasantness and soothing effect of the skin care products. Furthermore, they will be asked to score their global satisfaction with the skin care products. All these items will be evaluated by using a numerical rating scale (NRS). |
At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost |
|
Secondary |
Pruritus evaluation |
The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria |
Baseline |
|
Secondary |
Pruritus evaluation |
The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria |
At fraction 15/16 of radiotherapy (week 3) |
|
Secondary |
Pruritus evaluation |
The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria |
At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost |
|