Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04348955 |
| Other study ID # |
ICO-2019-08 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 7, 2019 |
| Est. completion date |
May 12, 2020 |
Study information
| Verified date |
April 2022 |
| Source |
Institut Cancerologie de l'Ouest |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In spite of progresses made in the medical and nurse announcement (linked to the cancer
plan), still a lot of patients fell lost, anxious, especially during the first venue at the
hospital day care for their chemotherapy. A longer time is necessary to give them again
explanation, to reassure and to listen to them. However, patients are not always in ability
to hear due to their psychological status. Young women seem to be more in distress, this is
linked to the fear of the disease, the change of their social status and the future of their
children.
It must be noted that there is an increase of complementary therapies including
Touch-Massage. Studies showed its interest on quality of life, anxiety, pain and fatigue.
The concept Touch-massage (TM) is defined as a benevolent concern that takes shape through
the touch and the sequence of gesture on all or parts of the body. This allows to calm, to
relax, to get back into shape, to reassure, to communicate or simply to provide well-being,
enjoyable to receive and to practice.
This treatment is already offered to the patients at the ICO, in priority while the first
course of chemotherapy, but in an informal way. I has been noticed a better-being after the
TM, and an increase of demand from the patients. This is why it would be interested to
measure the evolution of quality of life of those patients having a chemotherapy for a breast
cancer getting or not a TM.
Description:
The participation of the study will be offered to each patient coming for a first course of
chemotherapy at the hospital day care for an adjuvant breast cancer. The tracking of the
eligible patient will be done during the registration for the schedule.
The filling of the questionnaires will occur at the 4 first courses (C1 to C4). The Touch
Massage will be offered for the 3 first courses of chemotherapy (C1 to C3). The patient can
refuse the TM but she will have to fill the questionnaires.
At each moment, the patient can withdraw from the study, the TM can be offered according to
the availability of the team and of the choice of the patient during the course of
chemotherapy.
The questionnaire collection will be done in the patient's room. The quality of life will be
evaluated based on the questionnaires EORTC, QLQ C30 and BR23 at C1 and C2. The evaluation of
the quality of life at the fourth course will allow to estimate the quality of life after 3
complete courses of chemotherapy. Alongside, the anxiety will be evaluated with the anxiety
scale STAI from C1 to C3, when the patient just arrives in the service and before she leaves.
At the fourth course, the questionnaire will be filled only at the arrival.
After the filling of the questionnaires, the patient will be seen by the medical doctor of
the service and the nurse who will take charge of her for the chemotherapy.
According the availability of the service, the patient will receive the TM if she wants. A
member of the nursing staff formed to the TM (formation dispensed to the ICO) will perform
the TM. It will be done during the chemotherapy, during the perfusion of ENDOXAN, which takes
an hour. The TM will last 20 minutes. In this way, the TM will not delayed, prolonged and
disturb the treatment. At C4, there will not be a TM.
