Effect of a physical activity promotion program offered online or via blended care on physical activity level in breast and prostate cancer survivors: The PABLO Trial

Recruiting

• Conditions: breast carcinoma / breast cancer; prostate carcinoma / prostate cancer; 10027656

• Registration Number: NL-OMON46574
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 246

Inclusion Criteria

- Histologically confirmed primary breast or prostate cancer (stages: T1 - T4, N0 - N3 and M0)
- Primary treatment should have been completed a minimum of 3 months and a maximum of 36
months prior to study entry.
- Should not have signs of recurrence or progression at time of study entry.
- Should have access to the internet in their home environment.
- Should have basic proficiency in using online applications.
- Should have a DIGID authentication code (to log into the program), or willing to obtain it.
- Patients may currently be receiving adjuvant (anti)hormonal therapy.

Exclusion Criteria

- Patients who are unable to or cannot safely perform unsupervised exercise at the at the
recommended levels
- Patients who lack basic proficiency in Dutch.
- Patients who have serious cognitive or psychiatric problems that would preclude them from
following the intervention or completing the study questionnaires.
- Patients participating in concurrent studies or rehabilitation programs containing psychosocial
and/or exercise interventions.
- Patients who already meet the PA guideline of >150 min/week of moderate to vigorous PA for
longer than six months (patients in the maintenance stage according to TTM). To take into account a *30% overestimation of self-reported PA, we will be excluding patients who report > 200 min/week MVPA for longer than 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is change in minutes of weekly moderate to vigorous<br /><br>physical activity from baseline to 6 and 12 months as assessed by<br /><br>accelerometer. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>secondary outcomes are: Self-reported physical activity (IPAQ). Stage of<br /><br>change, fatigue (MFI), mood (POMS), HRQOL (SF-36 and EQ5D) will be assessed by<br /><br>questionnaires.At baseline, 6 and 12 months. Medical consumption (iMCQ) and<br /><br>productivity costs (iPCQ) will be measured at 6 and 12 months by questionnaire.</p><br>