QUALIOR Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program

N/AActive Not RecruitingNCT03169075

UNICANCER190 enrolled

Overview

This phase II-III study will be randomized (2:1) patients starting first-line oral targeted therapies (OTT) for metastatic cancer between an individualized supervised physical exercise programs (SPEP) by a personal coach, and recommended physical exercises via a booklet. Eligible patients will have received ≤2 lines of metastatic chemotherapy, Eastern Cooperative Oncology Group Performance status (ECOG PS) ≤2, controlled pain (visual analogue scale (VAS) \<3/10), and life expectancy ≥3 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

190

Conditions

Home Based Standardised Adapted Physical Activity Programme Patients Taking Oral Targeted Therapy for Metastatic Cancer

Interventions

A weekly supervised physical activity session of 60 min at the patient's home is planned for 3 months. These sessions will be supervised by an educator or physiotherapist trained, with respect to the pathology and the clinical study, specifically for this activity (Fédération Française Sport et Cancer) . The proposed exercises will be normalized and adapted to each patient's profile. Self reported questionnaires: FACT-F, FACT-G, EQ-5D, FAACT module AC/S, FACT-Gog, HADS, IPAQ, Evaluation by a coach VAE

Adapted physical activityBEHAVIORAL

Program based on the recommendations for performing a physical activity. A booklet containing physical activity recommendations will be given to the patients after randomization. The weekly sessions at the patients home for the experimental group (Program A) must begin as soon as possible within the 15 days after starting oral targeted therapy. Self reported questionnaires: FACT-F, FACT-G, EQ-5D, FAACT module AC/S, FACT-Gog, HADS, IPAQ

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient's ≥18 years old. 2. Patient treated for a metastatic solid tumour within the following 4 cohorts: breast cancer, kidney cancer, lung cancer, and other tumours treated with oral targeted therapies (including melanomas, sarcomas, hepatic sarcomas, and colon cancers). 3. Patients starting first-line oral targeted therapy, with market authorisation. The targeted therapy may be associated with hormonal therapy. 4. Patients may have been treated with immunotherapy. 5. Patients may have received chemotherapy (≤2 lines) for their metastatic disease. 6. Life expectancy of ≥3 months. 7. ECOG performance status ≤2. 8. Patients able to comply with the constraints of the SPEP protocol. 9. Pain under control (VAS ˂3; 0-10 scale). 10. Haemoglobin level ≥9 g/dL. 11. Patient must have signed the informed consent form before any study-related procedures. 12. Patients must have public health insurance coverage. Exclusion Criteria: 1. Patient receiving an injectable targeted therapy. 2. Patient previously treated by more than 2 lines of treatment (previous treatment with cytokines are allowed) 3. Patient to be treated with chemotherapy associated with the oral targeted therapy (hormonal therapy is allowed). 4. Patient with known risk of fracture, symptomatic cardiac insufficiency (NYHA-3), respiratory insufficiency (grade 3), intense pain not controlled with analgesic treatment, and/or neuropathy (grade 3). 5. Patients with a history of cancer in the last 5 years (except basal cell carcinoma adequately treated and in situ cervical cancer treated and cured). 6. Patient treated with corticotherapy (˃1 month) before randomisation at a dose ˃1 mg/kg. 7. Bone metastases with risk of fractures. 8. Geographical, sociological, or psychological reasons that could potentially hampering compliance with the study protocol and follow-up schedule. 9. Patients with a history of non-compliance to medical treatment, reluctance or incapable to conform to the study protocol. 10. Persons deprived of liberty or under guardianship.

Locations (15)

ICO Paul Papin

Angers, France

CH Annecy Genevois - site d'Annecy

Annecy, France

CHRU de Besançon

Besançon, France

Centre François Baclesse

Caen, France

CH de Cholet

Cholet, France

GHMG - Institut Daniel Hollard

Grenoble, France

CHD Vendée

La Roche-sur-Yon, France

Hospices Civils de Lyon - Hôpital Louis Pradel

Lyon, France

CHU La Timone

Marseille, France

ICO RenéGauducheau

Nantes, France

...and 5 more locations

Outcomes

Primary Outcomes

FACT-F relative on Fatigue

Self reported Questionnaires

Time frame: Month 3 ( M3)

FACT-G

Self Reported Questionnaire relative on Well-Being Patient

Time frame: Month3 ( M3)

Secondary Outcomes

PFS

Progression Free Survival

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 75 months

Overall Survival

Time frame: From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 75 months

Quality of life

Self reported Questionnaire on quality of life

Time frame: Month 1, Month 2, Month 3, and every 3 months for 1 year

Fatigue

Self reported Questionnaire FACT-F on Fatigue

Time frame: Month 1, Month 2, Month 3, and every 3 months for 1 year

Fatigue

visual analogic scale for fatigue

Time frame: Month 1, Month 2, Month 3, and every 3 months for 1 year

Pain

visual analogic scale for pain (VAS)

Time frame: Month 1, Month 2, Month 3, and every 3 months for 1 year

Toxicities Secondaries effectsToxicities according NCI-CTC (National Cancer Institute Updates CTCAE to v.4.03. Common Terminology Criteria )

Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]).

Time frame: Baseline, Month 1, Month 2, Month 3, and every 3 months for 1 year

Compliance about oral targeted therapy

Self reported Questionnaire Morisky-Green

Time frame: Baseline, Month 1, Month 2, Month 3

Benefit of physical activity: walk

6 minutes walking test

Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year

Benefit of physical activity muscle function

muscle function

Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year

Benefit of physical activity muscle strength

muscle strength

Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year

Physical Activity IPAQ

self reported Questionnaire IPAQ ( International Physical Activity Questionnaire)

Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year

Physical Activity, Body Mass Index

Body Mass Index

Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year

Scores of anxiety and depression

Hospital Anxiety and Depression Scale (HADs)

Time frame: Baseline, Month 1, Month 2, Month 3

Cognitive functions

Self reported questionnaire FACT-Cog

Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year

Evaluation of Ingesta, Anorexia

Ingesta

Time frame: Baseline, Month 3

Evaluation of Ingesta, VAS

VAS

Time frame: Baseline, Month 3

Evaluation of Anorexia

Self reported FAACT (module A-C)

Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year