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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Home Based Standardised Adapted Physical Activity Programme; Patients Taking Oral Targeted Therapy for Metastatic Cancer
• Intervention / Treatment: Behavioral: Supervised physical exercise programs; Behavioral: Adapted physical activity

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49000
    • ICO Paul Papin
  • Annecy, France, 74474
    • CH Annecy Genevois - Site d'Annecy
  • Besançon, France, 25000
    • CHRU De Besancon
  • Caen, France, 14076
    • Centre Francois Baclesse
  • Cholet, France, 49300
    • CH de Cholet
  • Grenoble, France, MD Phd
    • GHMG - Institut Daniel Hollard
  • La Roche-sur-Yon, France, 85925
    • CHD Vendee
  • Lyon, France, 69000
    • Hospices Civils de Lyon - Hopital Louis Pradel
  • Marseille, France, 13000
    • CHU La Timone
  • Nantes, France, 44000
    • ICO RenéGauducheau
  • Nîmes, France, 30000
    • CH Nimes - Institut de Cancérologie du Gard
  • Paris, France, 75005
    • Institut Curie Paris
  • Rennes, France, 35042
    • Centre Eugène Marquis
  • Saint-Cloud, France, 92000
    • INSTITUT CURIE - Site René Huguenin St Cloud
  • Saint-Mandé, France, 94160
    • Hia Begin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FACT-F relative on Fatigue	Self reported Questionnaires	Month 3 ( M3)
FACT-G	Self Reported Questionnaire relative on Well-Being Patient	Month3 ( M3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression Free Survival	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
OS	Overall Survival	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	Month 1, Month 2, Month 3, and every 3 months for 1 year
Fatigue	Self reported Questionnaire FACT-F on Fatigue	Month 1, Month 2, Month 3, and every 3 months for 1 year
Fatigue	visual analogic scale for fatigue	Month 1, Month 2, Month 3, and every 3 months for 1 year
Pain	visual analogic scale for pain (VAS)	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]).	Baseline, Month 1, Month 2, Month 3, and every 3 months for 1 year
Compliance about oral targeted therapy	Self reported Questionnaire Morisky-Green	Baseline, Month 1, Month 2, Month 3
Benefit of physical activity: walk	6 minutes walking test	Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Benefit of physical activity muscle function	muscle function	Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Benefit of physical activity muscle strength	muscle strength	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)	Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Physical Activity, Body Mass Index	Body Mass Index	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)	Baseline, Month 1, Month 2, Month 3
Cognitive functions	Self reported questionnaire FACT-Cog	Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Evaluation of Ingesta, Anorexia	Ingesta	Baseline, Month 3
Evaluation of Ingesta, VAS	VAS	Baseline, Month 3
Evaluation of Anorexia	Self reported FAACT (module A-C)	Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year

Collaborators and Investigators

• Sponsor: UNICANCER
• Collaborators: CAMI: Sport & Cancer
• Investigators: Principal Investigator: Florence JOLY, MD PhD, Centre Francois Baclesse

Publications and helpful links

General Publications

• Joly F, Lefeuvre-Plesse C, Garnier-Tixidre C, Helissey C, Menneveau N, Zannetti A, Salas S, Houede N, Abadie-Lacourtoisie S, Stefani L, Nenan S, Rieger I, Durand-Zaleski I, Descotes JM, Anota A. Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial. BMC Cancer. 2020 Oct 9;20(1):975. doi: 10.1186/s12885-020-07381-4.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2017
• Primary Completion (Estimated): October 11, 2024
• Study Completion (Estimated): July 11, 2028

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Fatigue; Advanced cancer; Adapted physical activity; Randomized Study; Oral targeted therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: UC-0106/1510 SdS 01 QUALIOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No