Clinical trial NCT01977053: 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
Official title: Impact of a Telephonic Monitoring During Neo Adjuvant or Adjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-metastatic Patients With Breast Cancer
Non-metastatic Patients With Colon Cancer
Non-metastatic Patients With Rectal Cancer
Patients Undergoing Adjuvant Chemotherapy
Keywords: breast cancer
colon cancer
rectal cancer
adjuvant chemotherapy
phone calls
emotional states
quality of life
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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.

Primary outcomes:
measure: emotional state (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation)
timeFrame: Change from baseline in POMS-f score at 6 weeks
Secondary outcomes:
measure: Evolution of emotional states scores
timeFrame: 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
measure: toxicities
timeFrame: up to 15 weeks
measure: quality of life
timeFrame: Change from baseline in EORTC QLQ-C30 score at 6 weeks and Change from baseline in EORTC QLQ-C30 score at 12 weeks
measure: anxiety
timeFrame: up to 15 weeks
measure: caregiver mood states
timeFrame: 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
measure: patient satisfaction
timeFrame: up to 12 weeks
measure: relationship between psychosocial criteria and anxiety
timeFrame: up to 15 weeks
Other outcomes:
measure: intervention cost
timeFrame: up to 15 weeks
Locations:
city: Nice
country: France
facility: Centre Antoine Lacassagne
state: Cedex 2
city: Cagnes sur Mer
country: France
facility: Polyclinique St Jean
Study officials:
affiliation: Centre Antoine Lacassagne
name: Philippe FOLLANA, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ganz PA, Kwan L, Stanton AL, Krupnick JL, Rowland JH, Meyerowitz BE, Bower JE, Belin TR. Quality of life at the end of primary treatment of breast cancer: first results from the moving beyond cancer randomized trial. J Natl Cancer Inst. 2004 Mar 3;96(5):376-87. doi: 10.1093/jnci/djh060.
citation: Stanton AL. Psychosocial concerns and interventions for cancer survivors. J Clin Oncol. 2006 Nov 10;24(32):5132-7. doi: 10.1200/JCO.2006.06.8775.
citation: Carlson LE, Bultz BD. Cancer distress screening. Needs, models, and methods. J Psychosom Res. 2003 Nov;55(5):403-9. doi: 10.1016/s0022-3999(03)00514-2.
citation: Pitceathly C, Maguire P. The psychological impact of cancer on patients' partners and other key relatives: a review. Eur J Cancer. 2003 Jul;39(11):1517-24. doi: 10.1016/s0959-8049(03)00309-5.
citation: Vitek L, Rosenzweig MQ, Stollings S. Distress in patients with cancer: definition, assessment, and suggested interventions. Clin J Oncol Nurs. 2007 Jun;11(3):413-8. doi: 10.1188/07.CJON.413-418.