Interest of Touch-massage in Hospital Day Care
TOMAS
1 other identifier
observational
36
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2019
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 7, 2019
CompletedFirst Submitted
Initial submission to the registry
March 25, 2020
CompletedFirst Posted
Study publicly available on registry
April 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2020
CompletedApril 22, 2022
April 1, 2022
7 months
March 25, 2020
April 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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.
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
90 days
Evaluate the benefits of the TM on the anxiety
90 days
Study Arms (1)
women with adjuvant breast cancer
Women between 18 and 70 years old with an adjuvant breast cancer histologically characterized
Interventions
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)
Eligibility Criteria
Women between 18 and 70 years old with an adjuvant breast cancer histologically characterized
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Insitut de Cancérologie de l'Ouest
Angers, 49055, France
Insitut de Cancérologie de l'Ouest
Angers, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sandra PIQUIN, Nurse
Insitut de Cancérologie de l'Ouest
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2020
First Posted
April 16, 2020
Study Start
October 7, 2019
Primary Completion
May 12, 2020
Study Completion
May 12, 2020
Last Updated
April 22, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share