Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Behaviors and Mental Disorders

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Breast Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Gastrointestinal Diseases

Quality of Life

supervised exercise program education program on healthy habits Pharmacological treatment and selfcare encouragement

Pharmacological treatment and selfcare encouragement.

Both groups received standardized usual care. The EP group will receive, in addition, a nurse supervised exercise program for 2 months in the PHC and a second phase in community facilities during the remaining 10 month

Supervised Physical activity

education program on healthy habits for 2 months in the PHC and a second phase in community facilities during the remaining 10 months

education program on healthy habits

Gonzalo Grandes, Medicine

Maria Soledad Arietaleanisbeaskoa, Nurse

ARIETALEANIZBEASCOA MARISOL, NURSE

ARCE ARANA, NURSE

GRANDES GONZALO, Medicine

ARIETALEANIZBEASCOA MARIA SOLEDAD, NURSE

AIM: To evaluate the effectiveness and efficiency of an innovative exercise program (EP) for patients during treatment for gastrointestinal tumors, breast and non small cells lung cancer, in terms of improved quality of life (QOL), fatigue and functional capacity respect the usual standard treatment (ST). DESIGN: Pragmatic randomized clinical trial in two parallel groups: EP and ST. SETTING: 7 Primary Health Centers (PHC) of the redIAPPISCIII, in coordination with oncology services. PARTICIPANTS: 250 patients with the above tumors, locally advanced or with metastatic disease, in adjuvant treatment, with Performance Status(PS) PS1-PS0. INTERVENTION: Both groups received standardized usual care. The EP group will receive, in addition, a nurse supervised exercise program for 2 months in the PHC and a second phase in community facilities during the remaining 10 months. MEASUREMENTS: The primary outcome measure is the change from baseline in the QOL+66 treatment, as measured by the specific questionnaire for patients with cancer EORTC QLQ-C-30 and Short Form(SF-36) overall. Secondary: fatigue (FACIT-F), radiological response, functional capacity (6 minutes walking and cardiopulmonary test), muscle strength and progression-free survival and overall. Predictors and confounders: age, sex, stage and tumor type, histology, treatment. ANALYSIS: We will compare between groups mean changes from baseline measurement of quality of life questionnaire (QOL) and other variables, on an intention to treat basis, using longitudinal mixed-effects models for repeated measures at 2, 6 and 12 months follow-up. Cost / effectiveness and cost / incremental utility associated to the program wil be estimated.

Clinical Trial: Effectiveness and Efficiency of Physical Exercise in Cancer Patients

PHYSICAL EXERCISE TO IMPROVE THE QUALITY OF LIFE OF CANCER PATIENTS DURING TREATMENT PROCESS: EFICANCER STUDY

Basque Health Service

Family Medicine specialist, master in epidemiology; Head of the Research Unit of Family Medicine of Bizkaia

Behavior, Addictive

patients will have a home-based physical activity prescription

patients will receive a physical activity counselling, without a real prescription and supervision

patients will have a home-based physical activity prescription, defined on the functional endurance and strength tests and they will be supervised for 3 months. Once monthly they will be examined by the oncologist (visit and questionnaires) and at weeks 4, 6, 8, 10 and 12 at the sport medicine center where the three tests will be repeated. Home-based activity will be monitored daily through a specific application. Endurance improvement is defined as an increase in walking speed; strength improvement is defined as an increase of the number of repetitions

Supervised physical activity

patients will receive a physical activity counselling, without a real prescription and supervision, and the three test will be repeated once a month for three months at the local sport medicine center and at the oncology center (visit and questionnaires). Counselling will include general informations on physical exercise

Unsupervised physical activity

Chiara Bennati, MD

Michela Spreafico

Chiara Bennati

This is an interventional, non-pharmacologic, randomized controlled study evaluating the impact on quality of life of a personalized exercise program in oncogene addicted lung cancer patients undergoing active treatment. Patients will be randomized 1:1 in two arms: arm A (interventional) and arm B (control). The program of physical activity will be established after a test done at the local clinical center and based on easy exercises already studied in other diseases (e.g. coronary syndrome or organ transplant). A smartphone application will allow patients to register their daily physical activity and to easily recover data on strength and endurance. Patients in Arm A will have a home-based physical activity prescription and will be supervised at weeks: 4, 6, 8, 10, 12 by the oncologist and an exercise expert of the local sport center through three exercises (body composition test, endurance test and strength test) and questionnaires. Home-based activity will be monitored daily though a specific application (provided by Technogym). Patients in Arm B will receive an exercise counselling without a subsequent supervision. The three tests and questionnaires will be repeated once a month for three months at the local sport center and oncology center. Counselling will include general information on exercise. Patients will undergo blood sampling at baseline, week 4 and week 12 in order to evaluate changes in their immunological state (lymphocyte populations and cytokines).

This is an interventional, non pharmacological, randomized controlled trial evaluating the impact on quality of life of a personalized exercise program in oncogene addicted lung cancer patients undergoing active treatment.

At Baseline every patient will receive three tests at the Division of Sport Medicine of Azienda Unità Sanitaria Locale (AUSL) of Romagna (Ravenna)

1. Body composition Analysis: Height, Weight, Bioimpedentiometry (resistance and reactance), Volume of Oxygen (VO2) max.
2. Endurance test: 1 Km treadmill test.
3. Strength test: Repetition of three different exercises (Chest press - upper limbs; Leg press - lower limbs; Lat pull down or Lat Machine or Upper Back).

After the three tests have been performed patients will be evaluated for eligibility and randomized into two arms: Arm A (interventional) and Arm B (control).

The program will be guided (prescribed and supervised) by an oncologist and a sport medicine doctor.

Arm A (interventional): patients will have a home-based physical activity prescription, defined on the functional endurance and strength tests and they will be supervised for 3 months. Once monthly they will be examined by the oncologist (visit and questionnaires) and at weeks 4, 6, 8, 10 and 12 at the sport medicine center where the three tests will be repeated. Home-based activity will be monitored daily through a specific application (provided by Technogym). Endurance improvement is defined as an increase in walking speed; strength improvement is defined as an increase of the number of repetitions.

Arm B (control): patients will receive a physical activity counselling, without a real prescription and supervision, and the three test will be repeated once a month for three months at the local sport medicine center and at the oncology center (visit and questionnaires). Counselling will include general informations on physical exercise.

Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment

Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment: a Randomized Controlled Trial

To evaluate the impact of a personalized prescription of physical exercises monitored through a special smartphone application on quality of life assessed with the Italian version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)

To evaluate the impact of a personalized prescription of physical exercises monitored through a special smartphone application on quality of life assessed with the Italian version of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire for lung cancer (QLQ-LC29)

To evaluate the impact of a personalized prescription of physical exercises monitored through a special smartphone application on quality of life assessed with the Italian version of Beck Depression Inventory II (BDI-II)

To evaluate the adherence to the step-counter and the strength training prescription monitored through a specific smartphone application. the number of weeks (at least 9 out of 12 weeks) a subject follows the personalized activity prescription will be measured

Functional capacity will be measured through the 1 Km treadmill test (at baseline; at week 4, week 8 and at week 12): arm A versus arm B. For those in the experimental arm, as the individual progresses with the exercise plan, the exercise dosage will be modulated to facilitate improvements.

Muscle strength will be measured through the maximum repetition tests (at baseline; at week 4, week 8 and at week 12): arm A versus arm B. For those in the experimental arm, as the individual progresses with the exercise plan, the exercise dosage will be modulated to facilitate improvements.

Monitoring the frequency, duration, and severity of adverse events (AEs), through physical examinations, changes in vital signs and through clinical laboratory blood.

Overall survival (OS), defined as the time from randomization to death from any cause.

Patient's satisfaction of an App-based system to guide and monitor home-based physical activity is assessed by dedicated questionnaire addressing specific issues

T Lymphocytes modulation during physical activity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial: Effectiveness and Efficiency of Physical Exercise in Cancer Patients	NCT01786122	Non-Small-Cell ... Digestive Syste... Breast Neoplasm...	Supervised Phys... education progr...	18 Years - 70 Years	Basque Health Service
Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment	NCT05306652	Non-Small Cell ...	Supervised phys... Unsupervised ph...	18 Years -	AUSL Romagna Rimini
Clinical Trial: Effectiveness and Efficiency of Physical Exercise in Cancer Patients	NCT01786122	Non-Small-Cell ... Digestive Syste... Breast Neoplasm...	Supervised Phys... education progr...	18 Years - 70 Years	Basque Health Service
Clinical Trial: Effectiveness and Efficiency of Physical Exercise in Cancer Patients	NCT01786122	Non-Small-Cell ... Digestive Syste... Breast Neoplasm...	Supervised Phys... education progr...	18 Years - 70 Years	Basque Health Service

Spots Global Cancer Trial Database for supervised physical activity