CancerREHABIMNCT06441773
Impact of Respiratory Rehabilitation on Quality of Life in Patients With Metastatic Non-small Cell Lung Cancer Treated With Immunotherapy and Chemotherapy in the Maintenance Phase
A study testing Respiratory Rehabilitation in people with Cancer, run by University Hospital, Brest at 3 sites in France.
Trial summary
Lung cancer is highly prevalent, with approximately 46,363 new cases in 2018, accounting for 20.6% of cancer deaths in France. At diagnosis, 70% of patients have advanced or metastatic cancer, treatable only by palliative care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Respiratory Rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 3 sitesFrance
- Study dates
- 21 Nov 2025to 21 Nov 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
- Histologically proven stage IV non-small cell lung cancer patient
- First-line treatment with chemotherapy combined with immunotherapy in the maintenance phase
- Adenocarcinoma patient: maintenance with Alimta combined with pembrolizumab
- Squamous cell carcinoma patient: maintenance with pembrolizumab alone
- Age of at least 18 years
- Performance status of 0 or 1
Show all 14Show fewer
- Estimated life expectancy > 12 weeks
- No contraindications to respiratory rehabilitation
- Adequate organ function, demonstrated by laboratory results within the last 3 weeks, allowing maintenance treatment:
- Normal liver function: bilirubin < 1.5 x ULN, ALT and AST < 2.5 x ULN or < 5 x ULN in the case of liver metastases.
- Renal function (creatinine clearance calculation of at least > 45 mL/min).
- Hematological function: absolute neutrophil count > 1.5 x 10^9/L and/or platelets > 100 x 10^9/L, hemoglobin > 8 g/dL.
- Informed consent to participate in the study must be signed
- Patient must be affiliated with or beneficiary of social security
Who cannot join
- Small cell lung cancer, mesothelioma, neuroendocrine lung cancer
- Patients with orthopedic disorders preventing respiratory rehabilitation that, in the investigator's opinion, could interfere with respiratory rehabilitation
- Unresolved toxicity from previous treatment of grade > 1 (except alopecia) that, in the investigator's opinion, could interfere with respiratory rehabilitation
- Symptomatic brain metastases (corticosteroid treatment is allowed if the doses administered are stable for at least one month before inclusion)
- Bone metastases preventing respiratory rehabilitation
- Contraindication to respiratory rehabilitation
Show all 10Show fewer
- Uncontrolled infection
- Pregnancy and breastfeeding
- Surgery within two months prior to inclusion that could interfere with respiratory rehabilitation
- Persons under legal protection (guardianship or curatorship) or deprived of liberty
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
CHU Brest
Brest, 29609
Renaud DESCOURT, Dr, 02 98 22 33 96, renaud.descourt@chu-brest.fr
Renaud DESCOURT, Dr
- Recruiting
CH Morlaix
Morlaix, 29600
Marc BEAUMONT, 02 98 62 61 60, mbeaumont@ch-morlaix.fr
Marc BEAUMONT
- Recruiting
CH Cornouaille
Quimper, 29107
Florence VERGNE-MENEZ, Dr, 02 98 52 60 60, florence.vergne@ch-cornouaille.fr
Florence VERGNE-MENEZ, Dr
About this study
Lung cancer is highly prevalent, with approximately 46,363 new cases in 2018, accounting for 20.6% of cancer deaths in France. At diagnosis, 70% of patients have advanced or metastatic cancer, treatable only by palliative care. Respiratory rehabilitation aims to reduce symptoms, enhance performance, increase autonomy, and improve patients\&#39; quality of life. While effective for COPD patients and other conditions causing dyspnea, its benefits in advanced, non-operable lung cancer are less studied. Some studies have shown the feasibility and safety of respiratory rehabilitation, but few have compared its impact on non-operable lung cancer patients or assessed its effect on quality of life. The main objective of the proposed study is to evaluate the impact of a respiratory rehabilitation program on the quality of life of patients with non-small cell lung cancer (NSCLC) undergoing maintenance chemotherapy and immunotherapy, compared to a control group receiving standard care.
Read the detailed description
Lung cancer accounts for an estimated 46,363 new cases in 2018. At the time of diagnosis, 70% of patients have locally advanced or metastatic cancer that can no longer be treated by surgery, but only by palliative therapy. It is the 4th most common cancer in France, and the most common worldwide. Lung cancer accounts for 20.6% of all cancer deaths in France.
Respiratory rehabilitation aims to minimize symptoms linked to the underlying pathology, and to enhance performance, increase autonomy and promote activities of daily living. It also aims to improve health-related quality of life and long-term maintenance of behavioral changes. It has been shown to be effective for COPD patients. Respiratory rehabilitation has also demonstrated its benefits in other pathologies whose common denominator is dyspnea, such as interstitial lung disease and pulmonary hypertension. In the case of operable lung cancers, numerous studies have focused on the preoperative and postoperative benefits.
Very few studies have focused on its benefits in advanced, non-operable lung cancer.
The team of Olivier et al. studied the benefits of home respiratory rehabilitation for 8 weeks in patients with advanced or metastatic lung cancer or mesothelioma treated with concomitant chemotherapy. Their study shows feasibility and safety for patients who complete the program, but the authors point out that the absence of a control arm and the small number of patients mean that the benefits of respiratory rehabilitation cannot be confirmed.
The team of Edbrooke et al., in 2019, is studying the value of a home-based rehabilitation program. The aim of the study is to demonstrate the efficacy of respiratory rehabilitation compared with standard care, a randomized controlled superiority trial. The study showed no statistically significant difference at 9 weeks on the primary endpoint (the 6-min walk test), due to a lack of power in the trial. A final study (Park et al.) showed the feasibility of outpatient rehabilitation in twelve patients, but did not conclude on the value of respiratory rehabilitation.
Thus, while a few studies have demonstrated the feasibility of respiratory rehabilitation in patients with bronchial cancer, few comparative studies have evaluated the impact of rehabilitation in patients with non-operable bronchial cancer, and no study has assessed the impact of respiratory rehabilitation on quality of life (as a primary endpoint), although this would appear to be an essential element in the care of these patients.
The main objective of our study is to evaluate the impact of a respiratory rehabilitation program (rehabilitation group) in patients with non-small cell lung cancer (NSCLC) treated with chemotherapy and immunotherapy in the maintenance phase compared with patients with NSCLC treated with chemotherapy and immunotherapy in the maintenance phase (control group), on quality of life at 2 months (8 weeks).
- Conditions
- Cancer
- Being tested
- Respiratory Rehabilitation
- Keywords
- Respiratory rehabilitation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory RehabilitationProcedure or surgery
An initial assessment is conducted upon admission to personalize the program. This includes:
Clinical examination Spirometry Maximum Inspiratory Pressure (PImax) measurement Multidimensional Dyspnea Profile questionnaire at end of TM6 Exercise Functional Testing Measurement of quadriceps strength and endurance Blood gases Educational interview and shared educational assessment London Chest Activity of Daily Living (LCADL) Tobacco and/or dietary consultation
The respiratory rehabilitation program, performed twice a week, includes:
Exercise training on an ergocycle and treadmill (30 minutes at ventilatory threshold for the ergocycle; 30 minutes at 60-80% walking speed for the treadmill; or dyspnea rated 4-6 on the Borg scale after endurance exercise) Quadriceps muscle strengthening Therapeutic education program Group gymnastics Smoking cessation assistance Socio-psychological and nutritional support
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Maintenance of chemotherapy and immunotherapy alone: without respiratory rehabilitation (control group) |
| Respiratory rehabilition | Experimental | Maintenance of chemotherapy and immunotherapy combined with a respiratory rehabilitation program of 2 sessions per week for 8 weeks (respiratory rehabilitation group) = 16 sessions Receives: Procedure: Respiratory Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Measurement Using EORTC QLQ-C30
The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-C30. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks
Measured: Week 0
Quality of Life Measurement Using EORTC QLQ-LC13
The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-LC13. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks
Measured: Week 0
Quality of Life Measurement Using EORTC QLQ-C30
The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-C30. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks
Measured: Week 8
Quality of Life Measurement Using EORTC QLQ-LC13
The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-LC13. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks
Measured: Week 8
Secondary outcomes (33)
Evaluation of quality of life using multiple modalities of the QLQ-C30.
Quality of life measurement using the functional scales and symptom scales of the QLQ-C30 questionnaire.
Measured: Week 0
Evaluation of quality of life using multiple modalities of the QLQ-C30.
Quality of life measurement using the functional scales and symptom scales of the QLQ-C30 questionnaire.
Measured: Week 8
Evaluation of quality of life using multiple modalities of the QLQ-C30.
Quality of life measurement using the functional scales and symptom scales of the QLQ-C30 questionnaire.
Measured: Month 6
Evaluation of quality of life using multiple modalities of the QLQ-C30.
Quality of life measurement using the functional scales and symptom scales of the QLQ-C30 questionnaire.
Measured: Month 12
Evaluation of quality of life using multiple modalities of the QLQ-C13.
Quality of life measurement using the functional scales and symptom scales of the QLQ-C13 questionnaire.
Measured: Week 0
Evaluation of quality of life using multiple modalities of the QLQ-C13
Quality of life measurement using the functional scales and symptom scales of the QLQ-C13 questionnaire.
Measured: Week 8
Evaluation of quality of life using multiple modalities of the QLQ-C13
Quality of life measurement using the functional scales and symptom scales of the QLQ-C13 questionnaire.
Measured: Month 6
Evaluation of quality of life using multiple modalities of the QLQ-C13
Quality of life measurement using the functional scales and symptom scales of the QLQ-C13 questionnaire.
Measured: Month 12
Evaluation of quality of life using the global health score of the QLQ-C30
Quality of life measurement using the global health score of the QLQ-C30 at 6 months and 1 year.
Measured: Month 6
Evaluation of quality of life using the global health score of the QLQ-C30
Quality of life measurement using the global health score of the QLQ-C30 at 6 months and 1 year.
Measured: Month 12
Evaluation of the number of deceased and surviving patients throughout the study follow-up.
Evaluation of the number of deceased and surviving patients throughout the study follow-up.
Measured: Week 8
Evaluation of the number of deceased and surviving patients throughout the study follow-up.
Evaluation of the number of deceased and surviving patients throughout the study follow-up.
Measured: Month 6
Evaluation of the number of deceased and surviving patients throughout the study follow-up.
Evaluation of the number of deceased and surviving patients throughout the study follow-up.
Measured: Month 12
Study of tumor response evaluation
Measurement of median Progression-Free Survival (based on RECIST criteria = tumor response evaluation) throughout the study follow-up.
Measured: Week 8
Study of tumor response evaluation
Measurement of median Progression-Free Survival (based on RECIST criteria = tumor response evaluation) throughout the study follow-up.
Measured: Month 6
Study of tumor response evaluation
Measurement of median Progression-Free Survival (based on RECIST criteria = tumor response evaluation) throughout the study follow-up.
Measured: Month 12
Evaluation of exercise capacity using 6-Minute Walk Test
Measurement of exercise capacity using the 6-Minute Walk Test (6MWT) at Week 0 and at 8 weeks (after 16 sessions for the respiratory rehabilitation group)
Measured: Week 0
Evaluation of exercise capacity using 6-Minute Walk Test
Measurement of exercise capacity using the 6-Minute Walk Test (6MWT) at Week 0 and at 8 weeks (after 16 sessions for the respiratory rehabilitation group)
Measured: Week 8
Evaluation of the number of events of interest
Evaluation of the number of events of interest
Measured: Week 8
Evaluation of the number of events of interest
Evaluation of the number of events of interest
Measured: Month 6
Evaluation of the number of events of interest
Evaluation of the number of events of interest
Measured: Month 12
Evaluation of the number of hospitalizations
Number of hospitalizations other than for maintenance treatment
Measured: Week 8
Evaluation of the number of hospitalizations
Number of hospitalizations other than for maintenance treatment
Measured: Month 6
Evaluation of the number of hospitalizations
Number of hospitalizations other than for maintenance treatment
Measured: Month 12
Evaluation of anxiety and depressive disorders
Measurement of anxiety and depressive disorders (HAD questionnaire) between Week 0 and Week 8
Measured: Week 0
Evaluation of anxiety and depressive disorders
Measurement of anxiety and depressive disorders (HAD questionnaire) between Week 0 and Week 8
Measured: Week 8
Evaluation of dyspnea with mMRC scale
Evaluation of dyspnea (MMRC scale) at Week 0 and at 8 weeks
Measured: Week 0
Evaluation of dyspnea with mMRC scale
Evaluation of dyspnea (MMRC scale) at Week 0 and at 8 weeks
Measured: Week 8
Evaluation of dyspnea with Dyspnea-12 questionnaire
Evaluation of dyspnea (Dyspnea-12 questionnaire) at Week 0 and at 8 weeks
Measured: Week 0
Evaluation of dyspnea with Dyspnea-12 questionnaire
Evaluation of dyspnea (Dyspnea-12 questionnaire) at Week 0 and at 8 weeks
Measured: Week 8
Evaluation of self-esteem with ISP-6 questionnaire
Evaluation of self-esteem (ISP-6 questionnaire) at Week 0 and at 8 weeks
Measured: Week 0
Evaluation of self-esteem with ISP-6 questionnaire
Evaluation of self-esteem (ISP-6 questionnaire) at Week 0 and at 8 weeks
Measured: Week 8
Evaluation of tiredness with EORTC QLQ FA-12 questionnaire
Evaluation of tiredness (EORTC QLQ FA-12 questionnaire) at Week 0 and at 8 weeks
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start21 Nov 2025
- Primary completion21 May 2028 (estimated)
- Study completion21 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Model description
- A two-center, randomized, open-label, parallel-group, ratio-distributed (1:1) trial comparing the impact of respiratory rehabilitation (RR) on quality of life at 2 months in patients with advanced NSCLC associated with RR versus patients with advanced NSCLC without RR.
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441773
- Sponsor's protocol ID
- 29BRC22.0255
- Other IDs
- 2024-A02083-44
- Acronym
- REHABIM
- Status last verified
- Jun 2026
- First submitted
- 29 May 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Respiratory Rehabilitation on Quality of Life in Patients With Metastatic Non-small Cell Lung Cancer Treated With Immunotherapy and Chemotherapy in the Maintenance Phase
- ClinicalTrials.gov ID
- NCT06441773
- Acronym / sponsor ID
- REHABIM / 29BRC22.0255
- Conditions
- Cancer
- Keywords
- Respiratory rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 21 May 2028 (estimated)
- Study completion
- 21 Nov 2028 (estimated)
- First posted
- 4 Jun 2024 (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.
Lung cancer is highly prevalent, with approximately 46,363 new cases in 2018, accounting for 20.6% of cancer deaths in France. At diagnosis, 70% of patients have advanced or metastatic cancer, treatable only by palliative care. Respiratory rehabilitation aims to reduce symptoms, enhance performance, increase autonomy, and improve patients\&#39; quality of life. While effective for COPD patients and other conditions causing dyspnea, its benefits in advanced, non-operable lung cancer are less studied. Some studies have shown the feasibility and safety of respiratory rehabilitation, but few have compared its impact on non-operable lung cancer patients or assessed its effect on quality of life. The main objective of the proposed study is to evaluate the impact of a respiratory rehabilitation program on the quality of life of patients with non-small cell lung cancer (NSCLC) undergoing maintenance chemotherapy and immunotherapy, compared to a control group receiving standard care.
Detailed description
Lung cancer accounts for an estimated 46,363 new cases in 2018. At the time of diagnosis, 70% of patients have locally advanced or metastatic cancer that can no longer be treated by surgery, but only by palliative therapy. It is the 4th most common cancer in France, and the most common worldwide. Lung cancer accounts for 20.6% of all cancer deaths in France.
Respiratory rehabilitation aims to minimize symptoms linked to the underlying pathology, and to enhance performance, increase autonomy and promote activities of daily living. It also aims to improve health-related quality of life and long-term maintenance of behavioral changes. It has been shown to be effective for COPD patients. Respiratory rehabilitation has also demonstrated its benefits in other pathologies whose common denominator is dyspnea, such as interstitial lung disease and pulmonary hypertension. In the case of operable lung cancers, numerous studies have focused on the preoperative and postoperative benefits.
Very few studies have focused on its benefits in advanced, non-operable lung cancer.
The team of Olivier et al. studied the benefits of home respiratory rehabilitation for 8 weeks in patients with advanced or metastatic lung cancer or mesothelioma treated with concomitant chemotherapy. Their study shows feasibility and safety for patients who complete the program, but the authors point out that the absence of a control arm and the small number of patients mean that the benefits of respiratory rehabilitation cannot be confirmed.
The team of Edbrooke et al., in 2019, is studying the value of a home-based rehabilitation program. The aim of the study is to demonstrate the efficacy of respiratory rehabilitation compared with standard care, a randomized controlled superiority trial. The study showed no statistically significant difference at 9 weeks on the primary endpoint (the 6-min walk test), due to a lack of power in the trial. A final study (Park et al.) showed the feasibility of outpatient rehabilitation in twelve patients, but did not conclude on the value of respiratory rehabilitation.
Thus, while a few studies have demonstrated the feasibility of respiratory rehabilitation in patients with bronchial cancer, few comparative studies have evaluated the impact of rehabilitation in patients with non-operable bronchial cancer, and no study has assessed the impact of respiratory rehabilitation on quality of life (as a primary endpoint), although this would appear to be an essential element in the care of these patients.
The main objective of our study is to evaluate the impact of a respiratory rehabilitation program (rehabilitation group) in patients with non-small cell lung cancer (NSCLC) treated with chemotherapy and immunotherapy in the maintenance phase compared with patients with NSCLC treated with chemotherapy and immunotherapy in the maintenance phase (control group), on quality of life at 2 months (8 weeks).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two-center, randomized, open-label, parallel-group, ratio-distributed (1:1) trial comparing the impact of respiratory rehabilitation (RR) on quality of life at 2 months in patients with advanced NSCLC associated with RR versus patients with advanced NSCLC without RR.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Maintenance of chemotherapy and immunotherapy alone: without respiratory rehabilitation (control group) |
| Respiratory rehabilition | Experimental | Procedure: Respiratory RehabilitationMaintenance of chemotherapy and immunotherapy combined with a respiratory rehabilitation program of 2 sessions per week for 8 weeks (respiratory rehabilitation group) = 16 sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically proven stage IV non-small cell lung cancer patient
- First-line treatment with chemotherapy combined with immunotherapy in the maintenance phase
- Adenocarcinoma patient: maintenance with Alimta combined with pembrolizumab
- Squamous cell carcinoma patient: maintenance with pembrolizumab alone
- Age of at least 18 years
Key exclusion criteria (10 listed)
- Small cell lung cancer, mesothelioma, neuroendocrine lung cancer
- Patients with orthopedic disorders preventing respiratory rehabilitation that, in the investigator's opinion, could interfere with respiratory rehabilitation
- Unresolved toxicity from previous treatment of grade > 1 (except alopecia) that, in the investigator's opinion, could interfere with respiratory rehabilitation
- Symptomatic brain metastases (corticosteroid treatment is allowed if the doses administered are stable for at least one month before inclusion)
- Bone metastases preventing respiratory rehabilitation
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 |
|---|---|---|
| Respiratory RehabilitationAn initial assessment is conducted upon admission to personalize the program. This includes: Clinical examination Spirometry Maximum Inspiratory Pressure (PImax) measurement Multidimensional Dyspnea Profile questionnaire at end of TM6 Exercise Functional Testing Measurement of quadriceps strength and endurance Blood gases Educational interview and shared educational assessment London Chest Activity of Daily Living (LCADL) Tobacco and/or dietary consultation The respiratory rehabilitation program, performed twice a week, includes: Exercise training on an ergocycle and treadmill (30 minutes at ventilatory threshold for the ergocycle; 30 minutes at 60-80% walking speed for the treadmill; or dyspnea rated 4-6 on the Borg scale after endurance exercise) Quadriceps muscle strengthening Therapeutic education program Group gymnastics Smoking cessation assistance Socio-psychological and nutritional support | Procedure or surgery | Respiratory rehabilition |
Primary outcome
Quality of Life Measurement Using EORTC QLQ-C30
Time frame: Week 0
The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-C30. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks
Quality of Life Measurement Using EORTC QLQ-LC13
Time frame: Week 0
The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-LC13. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks
Quality of Life Measurement Using EORTC QLQ-C30
Time frame: Week 8
The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-C30. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks
Quality of Life Measurement Using EORTC QLQ-LC13
Time frame: Week 8
The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-LC13. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks
33 secondary outcomes
Evaluation of quality of life using multiple modalities of the QLQ-C30.
Time frame: Week 0
Evaluation of quality of life using multiple modalities of the QLQ-C30.
Time frame: Week 8
Evaluation of quality of life using multiple modalities of the QLQ-C30.
Time frame: Month 6
Evaluation of quality of life using multiple modalities of the QLQ-C30.
Time frame: Month 12
Evaluation of quality of life using multiple modalities of the QLQ-C13.
Time frame: Week 0
Evaluation of quality of life using multiple modalities of the QLQ-C13
Time frame: Week 8
Evaluation of quality of life using multiple modalities of the QLQ-C13
Time frame: Month 6
Evaluation of quality of life using multiple modalities of the QLQ-C13
Time frame: Month 12
Evaluation of quality of life using the global health score of the QLQ-C30
Time frame: Month 6
Evaluation of quality of life using the global health score of the QLQ-C30
Time frame: Month 12
Evaluation of the number of deceased and surviving patients throughout the study follow-up.
Time frame: Week 8
Evaluation of the number of deceased and surviving patients throughout the study follow-up.
Time frame: Month 6
Evaluation of the number of deceased and surviving patients throughout the study follow-up.
Time frame: Month 12
Study of tumor response evaluation
Time frame: Week 8
Study of tumor response evaluation
Time frame: Month 6
Study of tumor response evaluation
Time frame: Month 12
Evaluation of exercise capacity using 6-Minute Walk Test
Time frame: Week 0
Evaluation of exercise capacity using 6-Minute Walk Test
Time frame: Week 8
Evaluation of the number of events of interest
Time frame: Week 8
Evaluation of the number of events of interest
Time frame: Month 6
Evaluation of the number of events of interest
Time frame: Month 12
Evaluation of the number of hospitalizations
Time frame: Week 8
Evaluation of the number of hospitalizations
Time frame: Month 6
Evaluation of the number of hospitalizations
Time frame: Month 12
Evaluation of anxiety and depressive disorders
Time frame: Week 0
Evaluation of anxiety and depressive disorders
Time frame: Week 8
Evaluation of dyspnea with mMRC scale
Time frame: Week 0
Evaluation of dyspnea with mMRC scale
Time frame: Week 8
Evaluation of dyspnea with Dyspnea-12 questionnaire
Time frame: Week 0
Evaluation of dyspnea with Dyspnea-12 questionnaire
Time frame: Week 8
Evaluation of self-esteem with ISP-6 questionnaire
Time frame: Week 0
Evaluation of self-esteem with ISP-6 questionnaire
Time frame: Week 8
Evaluation of tiredness with EORTC QLQ FA-12 questionnaire
Time frame: Week 8
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 17 Jun 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Rehabilitation in people with Cancer, run by University Hospital, Brest at 3 sites in France.
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 14 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Contact Florence Jacquemine Péguet-Ménard (06.23.25.64.50, jacquemine.menard@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Measurement Using EORTC QLQ-C30 (time frame: Week 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026.