|- candidate number||28368|
|- NTR Number||NTR6911|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-dec-2017|
|- Secondary IDs||2015-7904 Nederlands Kanker Instituut|
|- Public Title||Promotion of physical activity in breast and prostate cancer survivors|
|- Scientific Title||Effect of a physical activity promotion program offered online or via blended care on physical activity levels in breast and prostate cancer survivors|
|- ACRONYM||The PABLO Trial|
|- hypothesis||This study will evaluate the effectiveness of IPAS, with and without additional support, to improve objectively measured PA levels. We expect that IPAS will raise the level of PA more than normal care (UC) with a higher expected effect for IPAS + support. We also expect that cost effectiveness of the interventions is demonstrated in relation to UC. Secondary outcomes are self-reported PA, stage of change, fatigue, mood and health quality of life (HRQOL). Finally, explorers and mediators of the outcome will be studied in exploratory analyzes.|
|- Healt Condition(s) or Problem(s) studied||Breast cancer, Prostate cancer, Physical activity, Fatigue, Mood disorders|
|- Inclusion criteria||-Histologically confirmed primary breast or prostate cancer (stages: T1 - T4, NO - N3 and M0)|
-Primary treatment should have been completed a minimum of 3 months and a maximum of 12 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 (anti)hormonal adjuvant 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 per week of moderate to vigorous PA for longer than six months (patients in the maintenance stage according to TTM).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2018|
|- planned closingdate||1-mei-2020|
|- Target number of participants||246|
|- 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 level in relation to existing guidelines, using patient input obtained via questionnaires. Added support in the second intervention arm consists of structural and on-demand telephone contact with a physical therapist.|
|- Primary outcome||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 outcome||The secondary outcomes are: self-reported physical activity (IPAQ). Stage of change, fatigue (MFI) mood (POMS), HRQOL (SF-36, EQ5D) and 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.|
|- Timepoints||Baseline, T1 (after 6 months) and T2 (after 12 months). |
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| H.J. Wiel, van de|
|- CONTACT for SCIENTIFIC QUERIES|| H.J. Wiel, van de|
|- Sponsor/Initiator ||Antoni van Leeuwenhoek , Rijnstate Ziekenhuis|
(Source(s) of Monetary or Material Support)
|- Brief summary||Introduction: A higher level of PA is associated with beneficial effects on physical and psychosocial functioning of cancer survivors after treatment. However, cancer survivors often do not meet the recommended level of PA. The Netherlands Cancer Institute (NCI) created an internet-based program to support PA.|
Aim: To investigate the effectiveness of an online PA promotion program or blended care on PA levels in breast and prostate cancer survivors.
Methods: This multicenter trial will randomize participants into 3 study groups (N=82 per group) of men and women with histologically confirmed primary breast or prostate cancer (T1 – T4, N0 – N3, M0), who completed their treatment within 3 till 12 months at the NCI, Rijnstate or UMCU. One intervention group will receive access to the 6-months online intervention. The intervention is based on the Trans Theoretical Model and includes personal activity advice, information documents, video’s and assignments. Every month, the participants complete a short questionnaire online, which determines the stage of behavioral change regarding PA. Based on these results, a tailored and interactive program with assignments about goals, barriers and successes regarding PA of the participants will be provided. The second intervention group will receive access to the online intervention as well as to additional support by a monthly phone call of a physiotherapist. The control group will receive usual care and a leaflet with PA guidelines. The total study duration is 12 months. At baseline, 6 months and 12 months, the primary outcome PA will be objectively measured during 7 days by an accelerometer. The secondary outcomes; self-reported PA (IPAQ), Fatigue (MFI), Mood (POMS) and Health-Related Quality of Life (HRQoL) are measured by online questionnaires.
Analysis: The group differences for primary outcome PA and secondary outcomes; self-reported PA, fatigue, mood and HRQoL will be analyzed by linear mixed models.
Results are expected in 2020.
|- Main changes (audit trail)|
|- RECORD||21-dec-2017 - 4-jan-2018|