Breast Neoplasm Malignant FemaleTOMASNCT04348955
Interest of Touch-massage in Hospital Day Care
An observational study of Breast Neoplasm Malignant Female, run by Institut Cancerologie de l'Ouest at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasm Malignant Female
- What is being tested?
- Women between 18 and 70 years old with an adjuvant breast cancer histologically characterized
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Oct 2019to 12 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Adult, Older adult
Study population: Women between 18 and 70 years old with an adjuvant breast cancer histologically characterized
Who may be able to join
- women between 18 and 70 years old
- patient with histologically confirmed breast cancer
- adjuvant situation
- spoken language : french
- patient who never had chemotherapy in the past
Who cannot join
- Patient unable to sit
- Malformation of the back
- Wound at the level of the zones to massage
- Patient placed under the authority of a tutor
- Pregnant patient
Trial locations and contacts
2 sites in 1 country.
France2 sites
Insitut de Cancérologie de l'Ouest
Angers, 49055
Insitut de Cancérologie de l'Ouest
Angers
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Breast Neoplasm Malignant Female
- Being tested
- Women between 18 and 70 years old with an adjuvant breast cancer histologically characterized
- Keywords
- Breast cancer, Touch massage, anxiety, chemotherapy
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women between 18 and 70 years old with an adjuvant breast cancer histologically characterizedBehavioural
Quality of life and anxiety questionnaires before the course of chemotherapy (C1 and C4).
Touch-Massage during the course of chemotherapy (from C1 to C3) Anxiety questionnaire at the end of the course of chemotherapy (from C1 to C3)
| Study group | Role | What they receive |
|---|---|---|
| women with adjuvant breast cancer | Women between 18 and 70 years old with an adjuvant breast cancer histologically characterized Receives: Behavioral: Women between 18 and 70 years old with an adjuvant breast cancer histologically characterized |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the quality of life of patients with an adjuvant breast cancer treated at the ICO depending on the patient benefit or not from the TM during the chemotherapy in a hospital day care
Quality of life assessed using QLQ-C30 (Quality of Life of Cancer Patients) questionnaire. It is a general 30-item questionnaire composed by 5 functional scales, 3 symptom scales, a global health status and 5 single items assessing additional symptoms. The scales measures range score from 0 to 100. A high scale score represents a higher response level. For example, a high score for a functional scale represents a healthy level of functioning; a high score for the global health status represents a high quality of life; a high score for the symptom scales represents a high level of symptomatology or problems
Measured: 90 days
Change from basline quality of life during breast cancer treatment
Quality of life assessed using BR23 questionnaire. It is a 23-item questionnaire to measure the functioning and the symptoms associated of breast cancer. The functional dimension is composed of several scales: the reflection of the body, sexual functioning, sexual pleasure and perspective of future. The symptom dimension is composed of different scales such as the systemic therapy, side effects, mammary symptoms, hand symptoms and hair loss.
Measured: 90 days
Secondary outcomes (2)
Estimate the prevalence of the patients interested by the TM as part of the adjuvant care of a breast cancer at the ICO site of Angers
The prevalence of the number of patients interested by the TM is the ratio between the patients responding "yes" to the question : "would you like to receive a Touch-Massage" and the number of patients included in the study.
Measured: 90 days
Evaluate the benefits of the TM on the anxiety
Measure the anxiety with the help of the scale of the validated STAI (State Inventory Anxiety). A high score (more than 48 for men and 55 for women) represents a high level of anxiety.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start7 Oct 2019
- Primary completion12 May 2020
- Study completion12 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm Malignant FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra PIQUIN, Nurse, Study director, Insitut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348955
- Sponsor's protocol ID
- ICO-2019-08
- Acronym
- TOMAS
- Status last verified
- Apr 2022
- First submitted
- 25 Mar 2020
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Touch-massage in Hospital Day Care
- ClinicalTrials.gov ID
- NCT04348955
- Acronym / sponsor ID
- TOMAS / ICO-2019-08
- Conditions
- Breast Neoplasm Malignant Female
- Keywords
- Breast cancer, Touch massage, anxiety, chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women with adjuvant breast cancer | – | Behavioral: Women between 18 and 70 years old with an adjuvant breast cancer histologically characterizedWomen between 18 and 70 years old with an adjuvant breast cancer histologically characterized |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women between 18 and 70 years old with an adjuvant breast cancer histologically characterized
Key inclusion criteria (5 listed)
- women between 18 and 70 years old
- patient with histologically confirmed breast cancer
- adjuvant situation
- spoken language : french
- patient who never had chemotherapy in the past
Key exclusion criteria (5 listed)
- Patient unable to sit
- Malformation of the back
- Wound at the level of the zones to massage
- Patient placed under the authority of a tutor
- Pregnant patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Women between 18 and 70 years old with an adjuvant breast cancer histologically characterizedQuality of life and anxiety questionnaires before the course of chemotherapy (C1 and C4). Touch-Massage during the course of chemotherapy (from C1 to C3) Anxiety questionnaire at the end of the course of chemotherapy (from C1 to C3) | Behavioural | women with adjuvant breast cancer |
Primary outcome
Evaluate the quality of life of patients with an adjuvant breast cancer treated at the ICO depending on the patient benefit or not from the TM during the chemotherapy in a hospital day care
Time frame: 90 days
Quality of life assessed using QLQ-C30 (Quality of Life of Cancer Patients) questionnaire. It is a general 30-item questionnaire composed by 5 functional scales, 3 symptom scales, a global health status and 5 single items assessing additional symptoms. The scales measures range score from 0 to 100. A high scale score represents a higher response level. For example, a high score for a functional scale represents a healthy level of functioning; a high score for the global health status represents a high quality of life; a high score for the symptom scales represents a high level of symptomatology or problems
Change from basline quality of life during breast cancer treatment
Time frame: 90 days
Quality of life assessed using BR23 questionnaire. It is a 23-item questionnaire to measure the functioning and the symptoms associated of breast cancer. The functional dimension is composed of several scales: the reflection of the body, sexual functioning, sexual pleasure and perspective of future. The symptom dimension is composed of different scales such as the systemic therapy, side effects, mammary symptoms, hand symptoms and hair loss.
2 secondary outcomes
Estimate the prevalence of the patients interested by the TM as part of the adjuvant care of a breast cancer at the ICO site of Angers
Time frame: 90 days
Evaluate the benefits of the TM on the anxiety
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra PIQUIN, Nurse study director
Insitut de Cancérologie de l'Ouest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasm Malignant Female, run by Institut Cancerologie de l'Ouest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the quality of life of patients with an adjuvant breast cancer treated at the ICO depending on the patient benefit or not from the TM during the chemotherapy in a hospital day care (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.