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

NCT01977053 | Completed

• 2 other identifiers: 2012/042013-A00506-39
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-metastatic Patients With Colon Cancer; Non-metastatic Patients With Rectal Cancer; Patients Undergoing Adjuvant Chemotherapy; Non-metastatic Patients With Breast Cancer

Keywords

breast cancer; colon cancer; rectal cancer; adjuvant chemotherapy; phone calls; emotional states; quality of life

Outcome Measures

Primary Outcomes (1)

• emotional state (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation)

  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.

  Change from baseline in POMS-f score at 6 weeks

Secondary Outcomes (7)

• Evolution of emotional states scores

  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

• toxicities

  up to 15 weeks

• quality of life

  Change from baseline in EORTC QLQ-C30 score at 6 weeks and Change from baseline in EORTC QLQ-C30 score at 12 weeks

• anxiety

  up to 15 weeks

• caregiver mood states

  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

Other Outcomes (1)

• intervention cost

  up to 15 weeks

Study Arms (2)

A: Standard medical care

NO INTERVENTION

Arm A: standard supervision and medical care during an adjuvant chemotherapy treatment in France

B: telephonic monitoring

EXPERIMENTAL

Arm B: telephonic monitoring during inter-treatment intervals + personalized medical care.

Other: Clinical and psychosocial phone calls

Interventions

Clinical and psychosocial phone calls OTHER

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.

Also known as: medical care including social and psychological domains

B: telephonic monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (2)

Centre Antoine Lacassagne

Nice, Cedex 2, 06189, France

Location

Polyclinique St Jean

Cagnes-sur-Mer, 06800, France

Location

Related Publications (6)

• 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.

  PMID: 14996859 BACKGROUND

• 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.

  PMID: 17093275 BACKGROUND

• 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.

  PMID: 14581094 BACKGROUND

• 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.

  PMID: 12855257 BACKGROUND

• 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.

  PMID: 17623625 BACKGROUND

• Contu 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 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Philippe FOLLANA, Dr.

  Centre Antoine Lacassagne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: November 6, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

FR (2)