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Adaptated Physical Activity During Chemotherapy: Evaluation of the Psychological, Physiological and Biological Impact

NCT02785341 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2016-05-27

No results posted yet for this study

Summary

Although treatments significantly increase the life expectancy of cancer patients, their quality of life is more or less reduced. The development of supportive care, such as physical activity, is one of the tools that should be promoted to maintain quality of life and reduce treatment side effects, including fatigue.

This study was developed to understand the different biopsychosocial effects of a physical activity program carried out with patients suffering from various types of cancers, and to facilitate and improve the implementation of this type of activity in health care facilities.

Study randomized, controlled, cross-over intervention evaluating a 12-week supervised and adapted physical activity program.

Participants were assigned to one of two groups: Group A which first follows a 12-week physical activity program, then undergoes usual care for 12 additional weeks, or Group B, which continues usual care for 12 weeks (control group) and then starts the physical activity program for 12 additional weeks. Quality of life (with questionnaires for 2 groups) , well-being, fatigue, physical capacity, leptin concentration, goal setting and level of physical activity are evaluated during this protocol.

By understanding the multidimensional effects of a physical activity program for various cancer types, depending on the time of proposing the program, by evaluating the correlations among all these variables, and by evaluating long-term effects, the IPCAPA study contributes to identifying the physical activity program which will be effective, viable and feasible for all patients undergoing chemotherapy, whatever the type of cancer.

Conditions

Interventions

OTHER

questionnaires every 6 weeks (T0, T1, T2, T3 and T4)

Questionnaire MFI 20 Questionnaire life satisfaction Scale of measurement of the positive and negative affects Questionnaire QLQ-C30 (EORTC) Questionnaire on the personal goals

OTHER

6-minute walk test) every 6 weeks (T0, T1, T2, T3 and T4)

OTHER

leptin level with a blood test every 12 weeks (T0, T2 and T4)

blood sample

Sponsors & Collaborators

  • Institut Paoli-Calmettes

    lead OTHER

Principal Investigators

  • CAPPIELLO Maria Antonietta, MD · Institut Paoli-Calmettes

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-08-31
Completion
2015-08-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02785341 on ClinicalTrials.gov