The main objective of this study is to examine the effect of motivational coaching following oncological rehabilitation in cancer patients, on minutes of moderate- to- vigorous physical activity (MVPA) measured after six months, with an…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoints are minutes of moderate- to- vigorous physical activity
(MVPA) per week, assessed using an accelerometer and PA diary
Secondary outcome
Secondary endpoints are the VO2peak and other outcomes on the CPET (like
maximal heart rate (HRpeak) and maximal work rate (Wpeak), heart rate (HR),
work rate (W) and oxygen uptake (VO2) at the ventilatory anaerobic threshold
(VAT) and the respiratory compensation point (RCP); anthropometrics; muscle
strength; physical activity; Health Related Quality of Life (HRQoL); fatigue;
anxiety and depression symptoms, return to work (RTW) rates (%), exercise
participation, the experiences of participants with the transition from
supervised exercise rehabilitation to community-based exercise and the
acceptability of the coaching intervention. All measurements will be performed
at baseline and at six months follow-up, except for the semi-structured
interview which will only take place once, during the follow-up measurement.
Furthermore, patient characteristics, medical treatment, attrition to other
rehabilitation modalities and exercise history will be extracted from
electronic patient dossiers (EPD).
Background summary
Due to improved diagnosis and treatment modalities, cancer survival rates are
increasing. Consequently, the population of cancer-survivors is growing and
there is an urgent need for evidence-based survivorship-care to mitigate or
prevent side-effects. It has been well-established that a cancer rehabilitation
program that contains exercise training, positively affects these side-effects,
but less is known about the long-term effects. The existing evidence suggests
that cardiorespiratory fitness (CRF) does not further increase after completing
oncological rehabilitation and that cancer survivors often do not meet current
exercise guidelines. Motivational coaching for exercise adherence could be
effective to improve physical activity (PA) levels, CRF and other outcomes in
participants after completing oncological rehabilitation.
Study objective
The main objective of this study is to examine the effect of motivational
coaching following oncological rehabilitation in cancer patients, on minutes of
moderate- to- vigorous physical activity (MVPA) measured after six months,
with an accelerometer (MOX) and an activity diary.
Study design
Randomized Controlled Trial (RCT) with two parallel groups.
Intervention
The coaching program is called *Beweeg Bewust* and is guided by the
organization *Maastricht Sport*. The objective of the coaching program is to
motivate the patients to participate in exercise and to be sufficiently active
according to current exercise guidelines.
In this motivational coaching program, each patient will be linked to an
individual coach, who is a trained sports college student and will guide them
to stay physically active. During an intake assessment, the coach will give
individually tailored exercise advice, based on performance tests, personal
motivation and personal preferences. The coach will help them to choose a
sports activity that personally fits. Participants are offered the
possibilities to attend to the groups sessions of the organisation, to go to
other sports clubs or to perform exercise independently (like walking, cycling
etc.) After the intake, the program mainly contains electronic coaching
(e-coaching). Motivational coaching will be based on the COM-B model. In the
first twelve weeks, the coach will approach the participant weekly, by e-mail,
or when preferred by telephone. In this way, the coaches will stimulate the
participants to attend the sports activities. In the twelfth week , there will
be an evaluation appointment to give the coach and participant insight into the
progress of the participant. Intensity and frequency of coaching in the last
three months, will be based on this evaluation.
Study burden and risks
Risks associated with participation in this study are considered negligible.
Participants will be asked to visit the hospital once, to undergo two
performance tests at follow-up. These performance tests are safe in this
population, and could only result in some exhaustion or muscle soreness.
Furthermore, participants will be asked to wear an accelerometer for seven
consecutive days at baseline and follow-up. The accelerometer will be attached
with an anti-allergic plaster, so the risk for allergic reactions is low.
Participants are instructed to remove the plaster, when experiencing any itch
or redness. At baseline, participants fill in three questionnaires as a part of
usual care and two short structured interviews are added for the study. At
follow-up these three questionnaires and structured interviews will be
repeated. Furthermore, a subsample of the participants will participate in a
semi-structured interview about the experiences with with the transition from
supervised exercise rehabilitation to community-based exercise. This means
participants have to fill in 3 extra questionnaires and will undergo 4 or 5
extra interviews for the study. During the 7-day wearing time of the
accelerometer at both time points, participants have to fill in a PA diary. In
total, participants of this study will be asked to spend maximal four hours of
their time for all measurements.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Patients who are histologically confirmed with the diagnosis of cancer
- Patients who are aged >= 18 years
- Patients who undergo / completed treatment with curative intent
- Patients who completed the oncological exercise rehabilitation program at
MUMC+
Exclusion criteria
- Patient who are scheduled to undergo chemotherapy, radiotherapy or surgery in
the next 6 months
- Patients with cognitive disability, who are not able to understand
instructions and /or are not able to fill in the questionnaires.
- Patients who are unable to speak, understand and read the Dutch language
- Patients who are not able to perform basic activities of daily living (such
as walking) or patients who are suffering from other disabling comorbidity that
seriously hamper physical exercise (like severe heart failure, chronic
obstructive pulmonary diseases, neurological disorders or severe polyneuropathy)
- Patients who have an increased risk of falling, as assessed on the *4-Stage
Balance Test* (46).
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 | NL68040.068.18 |