Clinical trial · Interventional
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
Impact of a Telephonic Monitoring During Neo Adjuvant or Adjuvant Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-metastatic Patients With Breast Cancer | — | UNRESOLVED | — |
| Non-metastatic Patients With Colon Cancer | — | UNRESOLVED | — |
| Non-metastatic Patients With Rectal Cancer | — | UNRESOLVED | — |
| Patients Undergoing Adjuvant Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical and psychosocial phone calls | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- A: Standard medical care
- description
- Arm A: standard supervision and medical care during an adjuvant chemotherapy treatment in France
- type
- EXPERIMENTAL
- label
- B: telephonic monitoring
- description
- Arm B: telephonic monitoring during inter-treatment intervals + personalized medical care.
- interventionNames
- Other: Clinical and psychosocial phone calls
Primary outcomes (1)
- measure
- emotional state (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation)
- timeFrame
- Change from baseline in POMS-f score at 6 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDGanz 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. PMID 14996859
- BACKGROUNDStanton 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. PMID 17093275
- BACKGROUNDCarlson 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. PMID 14581094
- BACKGROUNDPitceathly 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. PMID 12855257
- BACKGROUNDVitek 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. PMID 17623625
- RESULTContu S, Hebert C, Ferrero JM, Creisson A, Mari V, Kaluzinski L, Hoch B, Largillier R, Borchiellini D, Viellard T, Chateau Y, Chamorey E, Follana P. EMOTION: Assessing the Impact of a Telephone Intervention for Patients With Breast Cancer, a Randomized Controlled Trial. JCO Oncol Pract. 2026 Mar;22(3):474-483. doi: 10.1200/OP-24-00857. Epub 2025 Jun 11. PMID 40499090