Impact of a Telephonic Monitoring During Inter-treatment Intervals on Emotional State, Quality of… (NCT01977053) | Clinical Trial Compass
CompletedNot Applicable
Impact of a Telephonic Monitoring During Inter-treatment Intervals on Emotional State, Quality of Life and Toxicities, on Neo Adjuvant or Adjuvant Chemotherapy-treated Patients
France274 participantsStarted 2013-09
Plain-language summary
In health care, the phone has emerged as a clinical tool in its own right, especially for the development of psychological support to patients and that, in many pathologies. Its potential in the development of psycho-social support was quickly identified.
However, to our knowledge, no prospective, randomized studies have evaluated the impact of a telephone call to both the anxiety and the management of side effects of neoadjuvant or adjuvant chemotherapy.
The patient incomplete care by the hospital system and the general practitioner during chemotherapy, as well as the lack of information and poor preparation and / or management of side effects, are a source of distress and lead to a decrease quality of life for the patient and his family.
We propose to determine on a population of 280 patients, the impact of two phone calls during 3 first inter-treatment intervals on the overall measure of mood states of the patient and his principal caregiver (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation). We will also study the gain in quality of life, on anxiety level, frequency and severity of toxicities, as well as emotional comfort of the procedure.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient older than 18.
* Patient surgically-treated or no for non inflammatory breast cancer or for colon cancer or rectal cancer.
* Patient to be treated by neo-adjuvant or adjuvant chemotherapy by 5-fluorouracil, epirubicin and cyclophosphamide (FEC)-docetaxel, docetaxel-cyclophosphamide, 5-fluorouracil/leucovorin with oxaliplatin(FOLFOX) or XELOX. A treatment with trastuzumab is allowed in association.
* Patient never treated by chemotherapy.
* Patient with Performance Status under or equal to 2.
* Patient with adequate hematopoietic, hepatic and cardiac functions according to the investigator.
* Patient having read with the information note and having signed the informed consent.
* Patient beneficiating from French health insurance cover.
Exclusion Criteria:
* Patient with psychological state, geographical remote or social problems that contraindicated the participation into the study according to the investigator.
* Patient that must be treated for a metastatic disease.
* Patient not able to attend all study visits.
* Patient not understanding French.
* Patient who don't have a phone.
* Vulnerable patient: pregnant or breast-feeding women, person deprived of freedom by an administrative or judicial decision, person older than 18 being the object of a legal protection measure or outside state to express their consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
emotional state (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation)
Timeframe: Change from baseline in POMS-f score at 6 weeks