Objective: This study will evaluate the effectiveness of IPAS, with and without additional support, for enhancing objectively measured PA levels. We expect that IPAS will increase levels of PA more than usual care (UC), with a larger expected effect…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
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
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.
Background summary
Rationale: Many breast and prostate cancer survivors experience negative
physical and psychosocial consequences of the disease and its treatment. There
is compelling evidence that physical activity (PA) counteracts many of these
consequences. Yet, cancer survivors often do not meet the recommended level of
PA. Therefore, we have developed an internet-based program (IPAS) to encourage
PA in an accessible way. As some studies suggest that supervised programs may
be more effective, we added minimal remote supervision that consists of
structural and on-demand telephone contact with a physical therapist to one of
the intervention arms.
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Study objective
Objective: This study will evaluate the effectiveness of IPAS, with and without
additional support, for enhancing objectively measured PA levels. We expect
that IPAS will increase levels of PA more than usual care (UC), with a larger
expected effect for IPAS + support. We also expect to demonstrate
cost-effectiveness of the interventions, compared to UC. Secondary outcomes are
self-reported PA, stage of change, fatigue, mood, and health-related quality of
life (HRQOL). Finally, moderators and mediators of the outcome will be studied
in exploratory analyses.
Study design
Study design: In this three armed randomized controlled trial patients will be
randomized to IPAS with or without additional support or to a usual care
control group.
Intervention
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.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Patients who participate will be asked to wear
an accelerometer for seven days at three time points and fill out a series of
questionnaires pre and post intervention. Patients in intervention groups will
be encouraged to be more physically active in a way that suits their situation
capabilities and interests best. It is anticipated that the program will have
direct benefit in terms of improvement of patients* fatigue and HRQOL, and will
help them in reaching their goals regarding PA. As patients with
contraindications to participating in unsupervised exercise are excluded, and
advices are directed at enhancing levels of daily type activities, risks of
participation are minimal.
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Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62269.031.17 |