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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

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 - Promotion of physical activity in breast and prostate cancer survivors

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46574
Enrollment
246
Registered
2018-09-17
Start date
2017-12-21
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast carcinoma / breast cancer

Interventions

Intervention (if applicable): IPAS consists of 6 months of noncommittal use and provides automated, algorithm-based tailored information on PA and PA assignments along with feedback on current PA le
Breast and Prostate cancer
Ehealth
Physical activity

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is change in minutes of weekly moderate to vigorous physical activity from baseline to 6 and 12 months as assessed by accelerometer.

Secondary

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

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)