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

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Supervised intervention group: 3 weekly sessions of 1 hour during 6 weeks of therapeutic exercise in which aerobic physical activity will be combined with exercise strength of different muscle groups plus stretches on a supervised basis and strengthening of self-care.

Unsupervised intervention group: The same therapeutic exercise protocol will be scheduled which will be carried out autonomously without supervision with telephone tracking.

6-week supervised educational program with 12-month follow-up compared to the same unsupervised intervention

Education program on healthy habits

Pablo García

Pablo García, PhD

AIM:To evaluate the effectiveness of a therapeutic exercise program (PET) in cancer patients in improving the quality of life and the need for supervision by health professionals during the performance of same after 6 weeks of intervention. DESIGN: Randomized and controlled clinical trial, parallel groups with active control group. With masking of randomization, patient evaluation and analysis of the data. SUBJETS OF STUDY: 58 patients diagnosed with breast and colon cancer and treated up to 2 years later, both with surgery, chemotherapy and hormonal treatments (inhibitors of aromatase, tamoxifen). INTERVENTION: both groups the treatment will be a common work-based therapeutic exercise program aerobic, strength-resistance and self-stretching, in addition to a reinforcement in recommendations usual self-care. The study includes two phases, phase of supervised work and phase of tracing. One of the groups will be supervised in the realization of PET for a period of 6weeks and the other group will do it autonomously and without supervision. The patients will be followed for 1 year, with five blind evaluations: at the beginning of the study, after 6 weeks of intervention, 3, 6 and 12 months after the start of the study.MEASUREMENTS: Principal: Quality of life assessed with the questionnaire measured with the European questionnaire Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-30). Pre-post intervention measure, 3, 6 and 12 months. Secondary: Cancer-related fatigue evaluated with the Functional Assessment of scale Chronic Illness Therapy - Fatigue (FACIT-F). Pre-post Measurement intervention, 3, 6 and 12 months. Functional capacity measured with the Test 6 minutes walking test. Pre-post Measurement intervention, 3, 6 and 12 months. Valuation of the measured force with manual hydraulic dynamometer and 5- test repetition sit-to-stand. Pre-post intervention measure, 3, 6 and 12 months.COST: effectiveness and cost / incremental utility associated to the program wil be estimated.

Study of the Effectiveness of Supervised vs. Non-Supervised Therapeutic Exercise in Cancer Patients

Quality of life assessed with the questionnaire measured with the European questionnaire Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30.

(EORTC QLQ-30). The QLQ-C30 questionnaire is a specific questionnaire for cancer, it is composed of 30 questions or items that assess the quality of life in relation to physical, emotional, social aspects and in general the level of functionality of patients diagnosed with cancer. The QLQ-C30 questionnaire is assigned values between 1 and 4 (1: not at all, 2: a little, 3: a lot, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 are assessed with score from 1 to 7 (1: bad, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, 0 being the worst possible and 100 the best.

Fatigue measurement with FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) questionaire.

The FACIT-F 13-item scale is designed on a 5-point Likert scale (0 = nothing; 1 = little; 2 = something; 3 = a lot; 4 = very much). The FACIT-F scale is designed so that a high score is good, the possible score is 0 to 52, 0 being the worst possible and 52 the best.

The 6-minute walk test consists of measuring the maximum distance that the patient is able to walk in 6 minutes, on a tour short in a hallway, simultaneously assessing heart rate, oxygen saturation and degree of dyspnea. Usually healthy people can walk between 400 and 700 meters in 6 minutes, depending on age, height and sex

Valuation of the measured force with manual hydraulic dynamometer and 5- test repetition sit-to-stand. The test assesses the act of sitting and standing for five repetitions as quickly as possible, in a chair without arms with a seat height of 43 cm. The participant crosses his arms over his chest and sits with his back against the vertical back of the chair. The performance of the test is based on its duration; Consequently, the shorter the time it takes for the patient to perform the test, the better it will be.

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
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
Study of the Effectiveness of Supervised vs. Non-Supervised Therapeutic Exercise in Cancer Patients	NCT04348188	Breast Cancer Colon Cancer	Education progr...	18 Years - 70 Years	Universidad Complutense de Madrid
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

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