Neoplasms

All Conditions

Head and Neck Neoplasms

The COACH group consists of newly diagnosed head and neck cancer patients seen in consultation for treatment information at Oncologic University Hospital during the first two months of the study. These patients receive coaching support from a specialized nurse, facilitating appointment scheduling, treatment coordination, and access to various rehabilitation services

The control group includes patients who received the treatment information during the third and fourth months of the study, without receiving specific coaching support.

Both groups of patients will complete quality of life questionnaires at the time of treatment information, at 3 months, 6 months and at 12 months.

COMPLETION OF QUESTIONNAIRES

AGNES DUPRET-BORIES

MARIANNE LESCOUZERES

Head and neck cancers (HNC) constitute a significant global health burden, ranking fourth in terms of cancer incidence and fifth in terms of cancer-related mortality. The management of HNC requires a complex array of consultations, examinations, rehabilitation, and lifestyle modifications, including addiction cessation. These cancers disproportionately affect economically disadvantaged, socially isolated individuals, and the elderly, resulting in disparities in healthcare access. Health coaching, an approach aimed at improving patients' health and quality of life by supporting behavior and lifestyle changes, has demonstrated effectiveness in various medical fields, including chronic diseases, medical oncology, and hematology. However, its application in head and neck cancer care remains limited, despite its potential benefits for this patient population.

This study is a prospective monocentric comparative investigation conducted over 12 months. Two groups are being compared: the COACH group and the control group. The COACH group consists of newly diagnosed head and neck cancer patients seen in consultation for treatment information at University Hospital during the first two months of the study. These patients receive coaching support from a specialized nurse, facilitating appointment scheduling, treatment coordination, and access to various rehabilitation services. In contrast, the control group includes patients who received treatment information during the third and fourth months of the study, without receiving specific coaching support. Both groups of patients will complete quality of life questionnaires at the time of treatment information, at 3 months, 6 months, and at 12 months.

Hypothesis: the investigators assume a minimum difference of 5 points between the control group and the coaching group.

Impact in Head and Neck Oncology of Support by a Nurse in the Patient's Care Pathway

Impact in Head and Neck Oncology of Support by a Nurse in the Patient's Care Pathway.

The main objective of this study is to evaluate the impact on the quality of life of patients treated for upper aerodigestive tract cancer of support by a nurse during the care pathway; and this from the moment of diagnosis and up to 12 months afterwards.

Measure of the impact on quality of life using the validated questionnaire most commonly used in oral cancerology, i.e. EORTC Quality of Life Questionnaire (QLQ) - Head and Neck Cancer (EORTC QLQ-H\&N43).

University Hospital, Toulouse

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Women candidate to adjuvant or neoadjuvant chemotherapy for breast cancer at the time of informed consent (interview before the start of CT)

Women who are receiving chemotherapy at the time of informed consent (interview within 1 year from beginning of CT)

Women who already received chemotherapy at the time of informed consent (interview after more than 4 years of CT end)

Completion of questionnaires at the time of study entry

Completion of questionnaires

Emilia Montagna, MD

The aim of the present study is to ask women treated with adjuvant or neoadjuvant chemotherapy for breast cancer what survival benefit would justify the treatment.

The benefit should be evaluated in terms of Survival rate trade off and Survival time trade off value. The analyses will be conducted into three different groups of patients to value the survival benefit expected:

1. before to start the chemotherapy
2. during chemotherapy
3. after the end of chemotherapy

The chemotherapy is generally proposed a large number of early breast cancer patients to reduce the risk of recurrence and death. However chemotherapy is associated with side effects that impact the quality of life of the patients.

Patients are more likely to accept treatment on the basis of presented relative rather than absolute risks and so the question arises as to whether unrealistic improvements in outcome are expected by patients. The interviews with patients in the proposed trial will elicit the expected gains both in terms of survival and life years and will be able to assess the proportion of patients who considered an improvement of realistic size was sufficient to justify the treatment.

PrefeRences And ChemoTherapy In Breast Cancer patiEnts

Patients' Preferences for Adjuvant or Neoadjuvant Chemotherapy in Breast Cancer

Risk reduction will be evaluated in the 40% and 20% 5 years risk scenarios

Prolonged survival time gain will be evaluated in the 5-yr and 15-yr survival scenarios

Collection of CONOR questionnaire (minimum value: 0, maximum value: 5 - higher scores mean a greater agreement with the statement)

Collection of Intolerance of Uncertainty Scale Short-Form (IUS-12) questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)

Collection of Regret and Disappointment Scale (RDS) questionnaire (minimum value: 1, maximum value: 7 - higher scores mean a greater agreement with the statement)

European Institute of Oncology

women candidate to receive ET and interviewed before starting treatment

women interviewed within 1 years from beginning of ET

women interviewed after more than 4 years but no more than 6 years of ET

Preference studies reveal how individuals trade-off the potential benefits, harms and inconveniences of a treatment by determining the minimum benefits they judge sufficient to make the treatment worthwhile.

They are especially relevant to adjuvant therapies where individuals must weigh up modest survival benefits only realized in time by no recurrence of their cancer with side effects predominantly experienced whilst on the treatment.

Previously it was reported, for example, that over 50% of women who had adjuvant chemotherapy for early breast cancer judged a 1% improvement in 5 year survival rates sufficient to make it worthwhile.

Larger survival benefits were required for longer duration adjuvant hormonal therapy where over 50% of women required at least 5% improvement in 5 year survival rates to make it worthwhile.

The endocrine therapy is generally proposed to all patients with endocrine positive early breast cancer to reduce the risk of recurrence and death. Moreover several data support that the prolongation of hormonal therapy (i.e. 10 years of hormonal treatment) is associated with statistical improved outcome.

In order to achieve the benefit related to hormonal therapy all women have to be treated despite the fact that the data and analyses are unable to differentiate as to whether a small prolongation in survival accrues to all women treated or a few patients survive who would otherwise have died. Moreover the hormonal therapy is associated with side effects that may impact the quality of life of the patients.

Patients are more likely to accept treatment on the basis of presented relative rather than absolute risks and so the question arises as to whether unrealistic improvements in outcome are expected by patients.

The interviews with patients in the proposed trial will elicit the expected gains both in terms of survival and life years and will be able to assess the proportion of patients who considered an improvement of realistic size was sufficient to justify the treatment and the prolongation of the treatment.

Several studies showed that choices are guided by the personal attitude to react and adapt to traumatic events, individual resilience.

It is important therefore to consider also the influence of these factors on the patients' treatment preferences.

For this reason, besides the elicitation of preferences, resilience and reaction to traumatic events will be assessed thorough validated questionnaires.

Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer

Evaluation of Endocrine Therapy and Patients Preferences in Early Breast Cancer - Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact in Head and Neck Oncology of Support by a Nurse in the Patient's Care Pathway	NCT06203808	Head and Neck C...	COMPLETION OF Q...	18 Years -	University Hospital, Toulouse
PrefeRences And ChemoTherapy In Breast Cancer patiEnts	NCT06332976	Female Breast C...	Completion of q...	18 Years -	European Institute of Oncology
Impact in Head and Neck Oncology of Support by a Nurse in the Patient's Care Pathway	NCT06203808	Head and Neck C...	COMPLETION OF Q...	18 Years -	University Hospital, Toulouse
Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer	NCT03939156	Breast Cancer Endocrine Breas...	Completion of q...	18 Years -	European Institute of Oncology

Spots Global Cancer Trial Database for completion of questionnaires