Trial record 15 of 2157 for:    Open Studies | "Drug Therapy"

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 (EMOTION)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Centre Antoine Lacassagne
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne
ClinicalTrials.gov Identifier:
NCT01977053
First received: October 22, 2013
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Non-metastatic Patients With Breast Cancer
Non-metastatic Patients With Colon Cancer
Non-metastatic Patients With Rectal Cancer
Patients Undergoing Adjuvant Chemotherapy
Other: Clinical and psychosocial phone calls

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Impact of a Telephonic Monitoring During Neo Adjuvant or Adjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by Centre Antoine Lacassagne:

Primary Outcome Measures:
  • emotional state (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation) [ Time Frame: Change from baseline in POMS-f score at 6 weeks ] [ Designated as safety issue: No ]
    comparison of the 2 types of monitoring in terms of overall measure of emotional state (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation) of patients, with Profile of Mood States (POMS-f) questionnaire.


Secondary Outcome Measures:
  • Evolution of emotional states scores [ Time Frame: Change from baseline in POMS-f score at 6 weeks; Change from baseline in POMS-f score at 9 weeks and Change from baseline in POMS-f score at 12 weeks ] [ Designated as safety issue: No ]

    To compare 2 types of supervision in terms of:

    The difference between the overall scores on the POMS-f before the start of treatment, at each treatment and after 3 courses of treatment


  • toxicities [ Time Frame: up to 15 weeks ] [ Designated as safety issue: Yes ]
    To compare 2 types of supervision in terms of proportion of patients with toxicity during treatment, and the maximum grade observed per patient

  • quality of life [ Time Frame: Change from baseline in EORTC QLQ-C30 score at 6 weeks and Change from baseline in EORTC QLQ-C30 score at 12 weeks ] [ Designated as safety issue: No ]

    To compare 2 types of supervision in terms of:

    The quality of life of the patient by the European Organization for Research and Treatment of Cancer Qulity of life questionnaire (EORTC QLQ-C30), before the start of treatment, during the 2nd cycle of chemotherapy and after three courses of treatment


  • anxiety [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]

    To compare 2 types of supervision in terms of:

    The level of anxiety assessed by the number of visits to psychologists, psychiatrists, the sub-score "Anxiety" obtained in the Hospital Anxiety and Depression State (HADS) questionnaire, the anxiolytics and antidepressants intakes


  • caregiver mood states [ Time Frame: Change from baseline in POMS-f score at 6 weeks; Change from baseline in POMS-f score at 9 weeks and Change from baseline in POMS-f score at 12 weeks ] [ Designated as safety issue: No ]

    To compare 2 types of supervision in terms of:

    - The overall scores obtained by the caregiver on the POMS-f before, during and after 3 courses of treatment


  • patient satisfaction [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    To compare 2 types of supervision in terms of overall satisfaction scores obtained by the patient after 3 courses of treatment

  • relationship between psychosocial criteria and anxiety [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]

    To compare 2 types of supervision in terms of:

    - The relationship between the presence of psychosocial frailty criteria and the level of anxiety for patients in group B (number of visits to psychologists, psychiatrists; anxiolytics and antidepressants intake; HADS anxiety scores)



Other Outcome Measures:
  • intervention cost [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
    To compare 2 types of supervision in terms of cost of the procedure (cost of consultations with psychologists, psychiatrists, cost of telephone calls)


Estimated Enrollment: 280
Study Start Date: September 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A: Standard medical care
Arm A: standard supervision and medical care during an adjuvant chemotherapy treatment in France
Experimental: B: telephonic monitoring
Arm B: telephonic monitoring during inter-treatment intervals + personalized medical care.
Other: Clinical and psychosocial phone calls

The standard medical supervision is defined as follows:

  • Prescription of prophylactics medication (corticoid, antiemetic, cream, mouthwash, etc) at each cycle of chemotherapy.
  • Nominative notebook containing details of chemotherapy administered and medical contacts.
  • Consultations with psycho-oncologist or psychiatrist (if necessary).

The intervention further comprises: nurse phone calls the 3rd and the 8th day of the first three cycles of treatment, and personalized medical care according to toxicities reported.

Other Name: medical care including social and psychological domains

Detailed Description:

Cancer is widely associated with the concept of psychological distress in a population of patients subject to numerous stressful events. Between 10 to 50% of patients with cancer and their families suffer from clinically significant psychological disorders.

The existence of a broad continuum of manifestations of distress makes it difficult for clinical evaluation. Underestimated and misjudged, it is not always taken into account appropriately. However, these problems have a direct impact not only on the quality of life of patients but also on their ability to share decisions , adhere to treatment, and therefore to get the best care available for the treatment of their cancer.

Interactions between the presence of psychopathological disorders, quality of life and treatment toxicities will be the focus of this study assessing the impact of telephonic monitoring (targeting clinical, psychological and social objectives) in patients with current chemotherapy.

There are communication difficulties on the distress between the patient and the doctor, in part due to the gap between the perceptions of the patient and the caregiver. Indeed, many studies have highlighted the important differences existing between subjective psychosocial needs of the patient and the physician's ability to detect them. In particular, the study of Fallowfield on nearly 2300 medical consultations shows that only 29% of patients whose threshold of distress is clinically significant are identified by their doctors. Similarly, the synthesis carried out in 2005 by Thorne et al. reported the impact of failures of communication between clinicians and patients on the psychosocial experience of illness and treatment, symptom management, decision making and quality of life.

Justification and research hypothesis

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 the first 3 inter-treatment intervals, the overall measure of mood states (anxiety, depression , confusion , anger , fatigue , vigor and interpersonal ) of the patient and his entourage . We also study the gain in quality of life, anxiety level, frequency and severity of toxicities, as well as emotional comfort of the procedure.

We propose to determine on a population of 280 patients, the impact of two phone calls during the 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01977053

Contacts
Contact: Cécile MICHEL, Ms +33 492031221 cecile.michel@nice.unicancer.fr

Locations
France
Centre Antoine Lacassagne Recruiting
Nice, Cedex 2, France, 06189
Principal Investigator: Philippe FOLLANA, Dr         
Sub-Investigator: Jean-Marc FERRERO, Pr.         
Sub-Investigator: Anne CREISSON, Dr.         
Sub-Investigator: Véronique MARI, Dr.         
Sub-Investigator: Christophe HEBERT, Dr.         
Sub-Investigator: Delphine BORCHIELLINI, Dr.         
Sub-Investigator: Eric FRANCOIS, Dr.         
Polyclinique St Jean Not yet recruiting
Cagnes sur Mer, France, 06800
Contact: Jérôme BARRIERE, Dr.    +33492135689    j.barriere@polesantesaintjean.fr   
Sub-Investigator: Gérard CAVAGLIONE, Dr.         
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
Principal Investigator: Philippe FOLLANA, Dr. Centre Antoine Lacassagne
  More Information

Publications:
Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT01977053     History of Changes
Other Study ID Numbers: 2012/04, 2013-A00506-39
Study First Received: October 22, 2013
Last Updated: October 30, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Antoine Lacassagne:
breast cancer
colon cancer
rectal cancer
adjuvant chemotherapy
phone calls
emotional states
quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 28, 2014