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

Sponsor

UNICANCER (Other)

Overall Status

Recruiting

CT.gov ID

NCT03169075

Collaborator

CAMI: Sport & Cancer (Other)

312

Enrollment

Locations

Arms

132

Anticipated Duration (Months)

20.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Home Based Standardised Adapted Physical Activity Programme Patients Taking Oral Targeted Therapy for Metastatic Cancer	Behavioral: Supervised physical exercise programs Behavioral: Adapted physical activity	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

312 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Study Evaluating the Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program, for Metastatic Cancer Patients Receiving Oral Targeted Therapy: The UNICANCER SdS 01 QUALIOR Study

Actual Study Start Date :

Jul 11, 2017

Anticipated Primary Completion Date :

Jun 11, 2023

Anticipated Study Completion Date :

Jul 11, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ARM A: A Supervised physical exercise programs (SPEP)	Behavioral: Supervised physical exercise programs 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
Active Comparator: ARM B: B Adapted physical activity (APA)	Behavioral: Adapted physical activity 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

Arm

Intervention/Treatment

Experimental: ARM A: A

Supervised physical exercise programs (SPEP)

Behavioral: Supervised physical exercise programs

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

Active Comparator: ARM B: B

Adapted physical activity (APA)

Behavioral: Adapted physical activity

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

Outcome Measures

Primary Outcome Measures

FACT-F relative on Fatigue [Month 3 ( M3)]
Self reported Questionnaires
FACT-G [Month3 ( M3)]
Self Reported Questionnaire relative on Well-Being Patient

Secondary Outcome Measures

PFS [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]
Progression Free Survival
OS [From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 75 months]
Overall Survival
Quality of life [Month 1, Month 2, Month 3, and every 3 months for 1 year]
Self reported Questionnaire on quality of life
Fatigue [Month 1, Month 2, Month 3, and every 3 months for 1 year]
Self reported Questionnaire FACT-F on Fatigue
Fatigue [Month 1, Month 2, Month 3, and every 3 months for 1 year]
visual analogic scale for fatigue
Pain [Month 1, Month 2, Month 3, and every 3 months for 1 year]
visual analogic scale for pain (VAS)
Toxicities Secondaries effectsToxicities according NCI-CTC (National Cancer Institute Updates CTCAE to v.4.03. Common Terminology Criteria ) [Baseline, Month 1, Month 2, Month 3, and every 3 months for 1 year]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Compliance about oral targeted therapy [Baseline, Month 1, Month 2, Month 3]
Self reported Questionnaire Morisky-Green
Benefit of physical activity: walk [Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year]
6 minutes walking test
Benefit of physical activity muscle function [Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year]
muscle function
Benefit of physical activity muscle strength [Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year]
muscle strength
Physical Activity IPAQ [Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year]
self reported Questionnaire IPAQ ( International Physical Activity Questionnaire)
Physical Activity, Body Mass Index [Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year]
Body Mass Index
Scores of anxiety and depression [Baseline, Month 1, Month 2, Month 3]
Hospital Anxiety and Depression Scale (HADs)
Cognitive functions [Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year]
Self reported questionnaire FACT-Cog
Evaluation of Ingesta, Anorexia [Baseline, Month 3]
Ingesta
Evaluation of Ingesta, VAS [Baseline, Month 3]
VAS
Evaluation of Anorexia [Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year]
Self reported FAACT (module A-C)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient's ≥18 years old.
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).
Patients starting first-line oral targeted therapy, with market authorisation. The targeted therapy may be associated with hormonal therapy.
Patients may have been treated with immunotherapy.
Patients may have received chemotherapy (≤2 lines) for their metastatic disease.
Life expectancy of ≥3 months.
ECOG performance status ≤2.
Patients able to comply with the constraints of the SPEP protocol.
Pain under control (VAS ˂3; 0-10 scale).
Haemoglobin level ≥9 g/dL.
Patient must have signed the informed consent form before any study-related procedures.
Patients must have public health insurance coverage.

Exclusion Criteria:

Patient receiving an injectable targeted therapy.
Patient previously treated by more than 2 lines of treatment (previous treatment with cytokines are allowed)
Patient to be treated with chemotherapy associated with the oral targeted therapy (hormonal therapy is allowed).
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).
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).
Patient treated with corticotherapy (˃1 month) before randomisation at a dose ˃1 mg/kg.
Bone metastases with risk of fractures.
Geographical, sociological, or psychological reasons that could potentially hampering compliance with the study protocol and follow-up schedule.
Patients with a history of non-compliance to medical treatment, reluctance or incapable to conform to the study protocol.
Persons deprived of liberty or under guardianship.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	ICO Paul Papin	Angers	France	49000
2	CH Annecy Genevois - site d'Annecy	Annecy	France	74474
3	CHRU de Besançon	Besançon	France	25000
4	Centre François Baclesse	Caen	France	14076
5	CH de Cholet	Cholet	France	49300
6	GHMG - Institut Daniel Hollard	Grenoble	France	MD Phd
7	CHD Vendée	La Roche-sur-Yon	France	85925
8	Hospices Civils de Lyon - Hôpital Louis Pradel	Lyon	France	69000
9	CHU La Timone	Marseille	France	13000
10	ICO RenéGauducheau	Nantes	France	44000
11	CH Nimes - Institut de Cancérologie du Gard	Nîmes	France	30000
12	Institut Curie Paris	Paris	France	75005
13	Centre Eugène Marquis	Rennes	France	35042
14	INSTITUT CURIE - Site René Huguenin St Cloud	Saint-Cloud	France	92000
15	HIA Begin	Saint-Mandé	France	94160