Home Based Standardised Adapted Physical Activity ProgrammeQUALIORNCT03169075

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

A study testing Supervised physical exercise programs and Adapted physical activity in people with Home Based Standardised Adapted Physical Activity Programme and Patients Taking Oral Targeted Therapy for Metastatic Cancer, run by UNICANCER at 15 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Home Based Standardised Adapted Physical Activity Programme, Patients Taking Oral Targeted Therapy for Metastatic Cancer
What is being tested?: Supervised physical exercise programs and Adapted physical activity
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 190 participants
Where: 15 sitesFrance
Study dates: 11 Jul 2017to 11 Jul 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

France15 sites

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

Other trials in France

About this study

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

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.

Conditions: Home Based Standardised Adapted Physical Activity Programme, Patients Taking Oral Targeted Therapy for Metastatic Cancer
Being tested: Supervised physical exercise programs, Adapted physical activity
Keywords: Adapted physical activity, Oral targeted therapy, Advanced cancer, Fatigue, Quality of life, Randomized Study
Medical subject headings: Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Supervised physical exercise programsBehavioural
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 activityBehavioural
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

Study groups in NCT03169075
Study group	Role	What they receive
ARM A: A	Experimental	Supervised physical exercise programs (SPEP) Receives: Behavioral: Supervised physical exercise programs
ARM B: B	Active comparator	Adapted physical activity (APA) Receives: Behavioral: Adapted physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (18)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jul 201711 Jul 2028

First posted30 May 2017
Study start11 Jul 2017
Primary completion30 Sep 2024
Study completion11 Jul 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Home Based Standardised Adapted Physical Activity ProgrammeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03169075
Sponsor's protocol ID: UC-0106/1510 SdS 01 QUALIOR
Acronym: QUALIOR
Status last verified: May 2026
First submitted: 22 May 2017
Last updated: 3 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

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.
PubMed 33036567

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03169075
Acronym / sponsor ID: QUALIOR / UC-0106/1510 SdS 01 QUALIOR
Conditions: Home Based Standardised Adapted Physical Activity Programme, Patients Taking Oral Targeted Therapy for Metastatic Cancer
Keywords: Adapted physical activity, Oral targeted therapy, Advanced cancer, Fatigue, Quality of life, Randomized Study
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 190 participants (actual)
Lead sponsor: UNICANCERUniversity, hospital or other
Collaborators: CAMI: Sport & Cancer
Study start: 11 Jul 2017 (actual)
Primary completion: 30 Sep 2024 (actual)
Study completion: 11 Jul 2028 (estimated)
First posted: 30 May 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ARM A: A	Experimental	Behavioral: Supervised physical exercise programsSupervised physical exercise programs (SPEP)
ARM B: B	Active comparator	Behavioral: Adapted physical activityAdapted physical activity (APA)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (10 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Supervised physical exercise programsA 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	Behavioural	ARM A: A
Adapted physical activityProgram 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	Behavioural	ARM B: B

Primary outcome

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

18 secondary outcomes

PFS
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
OS
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
Time frame: Month 1, Month 2, Month 3, and every 3 months for 1 year
Fatigue
Time frame: Month 1, Month 2, Month 3, and every 3 months for 1 year
Fatigue
Time frame: Month 1, Month 2, Month 3, and every 3 months for 1 year
Pain
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 )
Time frame: Baseline, Month 1, Month 2, Month 3, and every 3 months for 1 year
Compliance about oral targeted therapy
Time frame: Baseline, Month 1, Month 2, Month 3
Benefit of physical activity: walk
Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Benefit of physical activity muscle function
Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Benefit of physical activity muscle strength
Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Physical Activity IPAQ
Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Physical Activity, Body Mass Index
Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Scores of anxiety and depression
Time frame: Baseline, Month 1, Month 2, Month 3
Cognitive functions
Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Evaluation of Ingesta, Anorexia
Time frame: Baseline, Month 3
Evaluation of Ingesta, VAS
Time frame: Baseline, Month 3
Evaluation of Anorexia
Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
Derived from this study: PubMed 33036567Joly 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.
Individual participant dataSharing planned: No. Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Florence JOLY, MD PhD principal investigator

Centre François Baclesse

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FACT-F relative on Fatigue (time frame: Month 3 ( M3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03169075, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.