Educational Materials Development for Physical Activity in CAncer (EDuCA)

E.D.u.CA: a Guidebook to Increase Physical Activity Level in Cancer Patients

In cancer setting, physical exercise has emerged as an important factor to control cancer-related symptoms and improve patients' quality of life. In addition, the correlation between physical activity and survival is recently consolidating. Nevertheless, several previous studies have shown that the majority of cancer patients are insufficiently active. Written information, for example a guidebook, may be a good oppurtunity, to improve lifestyle. Developing and testing an exercise guidebook, based on Theory of Planned Behavior and specifically designed for cancer patients, may be an effective tool to deliver information and increase physical activity level in this population.

Study Overview

• Status: Unknown
• Conditions: Mixed Cancer
• Intervention / Treatment: Behavioral: Physical activity

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alice Avancini; Phone Number: 3403624264; Email: alice.avancini@univr.it

Study Locations

• Italy
  • Verona, Italy, 37131
    • Recruiting
    • University of Verona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• signed informed consent;
• confirmed cancer diagnosis.

Exclusion Criteria:

- sufficient physical activity level.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Physical exercise	Behavioral: Physical activity; The participants will receive the written exercise guidebook and a counselling by kinesiologist. Moreover, they will be instructed how to increase their physical activity level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physical activity level - using Godin's Leisure Time Exercise Questionnaire (GLTEQ)	Change from baseline physical activity level at 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
quality of life - using European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire" (EORTC QLQ C-30)	Change from baseline physical activity level at 4 weeks
Sedentary behavior - using Sedentary Behaviour Questionnaire (SBQ)	Change from baseline physical activity level at 4 weeks

Collaborators and Investigators

• Sponsor: Universita di Verona

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2020
• Primary Completion (ANTICIPATED): November 1, 2020
• Study Completion (ANTICIPATED): November 1, 2020

Study Registration Dates

• First Submitted: December 25, 2019
• First Submitted That Met QC Criteria: December 25, 2019
• First Posted (ACTUAL): December 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 25, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 67002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No