NCT04213235

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

December 30, 2019

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

December 25, 2019

Last Update Submit

December 25, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Physical activity level - using Godin's Leisure Time Exercise Questionnaire (GLTEQ)

    Change from baseline physical activity level at 4 weeks

Secondary Outcomes (2)

  • 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

Study Arms (1)

Physical exercise

EXPERIMENTAL
Behavioral: Physical activity

Interventions

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.

Physical exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed informed consent;
  • confirmed cancer diagnosis.

You may not qualify if:

  • \- sufficient physical activity level.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Verona

Verona, 37131, Italy

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

December 25, 2019

First Posted

December 30, 2019

Study Start

January 1, 2020

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

December 30, 2019

Record last verified: 2019-12

Locations