Study of Three Endpoints to Assess the Benefit of Rehabilitation in Patients With Advanced Non-small Cell Lung Cancer Controlled After at Least 6 Months of Systemic Treatment

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble

About this trial

The objective of this study is to identify an outcome that is relevant for assessing the benefit of rehabilitation in patients with advanced or metastatic non-small cell lung cancer whose disease has been stable or responding for at least 6 months with systemic treatment.

Many people living with lung cancer experience asthenia, which reduces daily activity, independence, and quality of life.

Regular physical activity (PA) is recommended for the management of all chronic diseases, including cancer. PA can be done independently by the patient or supervised by adapted physical activity instructors (EAPA) at home or in a day hospital (HDJ) in medical and rehabilitation care departments (SMR), where it is covered by social security.

Rehabilitation program and physical activity may help improve strength, function, and social participation, for patients with non-small cell lung cancer .

In this study, patients will participate in a 3-month rehabilitation program. We will measure quality of life, hand grip strength, and the Five Times Sit to Stand Test, before and after the program. Other measures will include daily step counts, nutrition, overall health status, continuation of cancer treatment, program adherence, and participant satisfaction.

About 63 participants will be recruited in several hospitals, including CHUGA, CHMS and CHANGE. This patients will be able to choose a program that suits them and is available as part of they care. We are expecting 50 patients to participate in one of the rehabilitation program.

The main goal is to identify the most useful outcomes to assess in future studies that will compare different rehabilitation approaches for people with lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients treated for NSCLC at CHUGA, CHMS, or CHANGE

Locally advanced or metastatic NSCLC

Tumor disease controlled for at least 6 months following any type of anti-tumor treatment

ECOG Performance Status 0 to 2

Disqualifiers

Initial management of the tumor disease started ≥ 2 years ago

Residual toxicity of grade ≥ 2

Estimated life expectancy less than 6 months (at the discretion of the investigator)

Patient with an absolute contraindication to physical activity at the time of consultation (e.g., unstable angina; acute intercurrent event...)

Trial population

The study population includes patients with metastatic or locally advanced non-small cell lung cancer whose tumor disease is controlled and who are at least 6 months post-treatment with any anti-tumor therapy. They must have a complaint related to physical activity.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

63 Participants
are grouped into 1 trial group
Group A: Patients with metastatic or locally advanced non-small cell lung cancer.

Trial outcomes

Primary outcomes

1

Hand-grip

Hand grip strength is measured with a hand dynamometer. It is a measure of grip strength in kilograms, which is associated with muscle mass. The subject holds the device in one hand, usually with the elbow at 90° and the wrist straight. On signal, they squeeze as hard as possible for a few seconds. The test is repeated 2-3 times for each hand, and the best or average value is recorded.

Time frame
periprocedural of the exercise rehabilitation program
2

EQ5DL Score

EQ5DL is a score about life quality. It includes two part: The first part assesses health in five dimensions, each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Each health state can potentially be assigned a summary index score based on societal preference weights for the health state. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part consists of a visual analogue scale (VAS) on which rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).

Time frame
periprocedural of the exercise rehabilitation program
3

Five Times Sit To Stand

The subject sits on a chair , with arms crossed over the chest. On the tester's signal, the subject stands up fully and sits back down five times as quickly as possible without using the arms for support. The time needed to complete the five repetitions is measured.

Time frame
periprocedural of the exercise rehabilitation program

Secondary outcomes

1

ONAPS-PAQ test

The Onaps-PAQ questionnaire assesses the level of physical activity and sedentary behavior during a typical week for the adult population. It is divided into three parts and 21 questions: activities at work, trips for practical purposes, and leisure or home activities. This questionnaire also assesses sedentary behavior in all areas of life (travel, work, leisure). Patients are considered to be very active, active, or inactive. There are also three levels of sedentary behavior: low, moderate, and high.

Time frame
periprocedural of the exercise rehabilitation program
2

ECOG-PS

It describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The ECOG Performance Status Scale measure how the disease impacts a patient's daily living abilities, known to physicians and researchers as a patient's performance status.

Time frame
periprocedural of the exercise rehabilitation program
3

CSQ-8

It is the Client Satisfaction Questionnaire. It will be use to measure and assess consumer satisfaction with health and human services. There are 8 questions, total scores range from 8 to 32, with the higher number indicating greater satisfaction.

Time frame
through study completion, an average of 3 months
4

Average number of steps in the previous week (using smartphone app)

If it's available, on a app, it is the number of steps the week before.

Time frame
periprocedural of the exercise rehabilitation program

Other outcomes

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