Primary Objective: To investigate the feasibility of a 12 -week postoperative Telerehabilitation program for patients with esophageal cancer treated with esophagectomy and suffering from postoperative complicationsSecondary Objective: To investigate…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility outcomes include willingness to participate in the study, refusal
rate, adherence to the Telerehabilitation intervention operationalized in
amount of sessions attended, performance rate of exercises, amount and duration
of email-, phone-, and/ or video calls conducted by patients and
physiotherapists, duration of treatment per session and adverse events (defined
as an unexpected negative effect directly related to the prescribed exercises)
and patient satisfaction
The Telerehabiliation intervention is considered as feasible if at least 80
percent adherence rate will be achieved, no adverse events will take place and
patient satisfaction will be scored positively.
Secondary outcome
Outcome data on effectiveness will be measurements of musculoskeletal- and
cardiovascular functions and activities as well as participation according to
the domains of the International Classification of Functioning, Disability and
Health (ICF)9.
These outcome data include hand grip strength as a predictor of overall muscle
strength 19, inspiratory and expiratory muscle strength, proximal muscle
strength of the lower extremity, maximal short exercise capacity, walking
capacity, self reported activities and quality of life.
Background summary
Improvement of functional status with physiotherapy is an important goal for
patients suffering from POC after esopahgectomy both during and after hospital
stay. Patients with esophageal cancer and suffering from POC are usually
referred to outpatient physiotherapy to further improve functional status.
However, these patients often deal with a temporary loss of mobility directly
postoperatively and they are at the same time confronted with integrated care
from multiple health providers. Therefore these patients might benefit from a
relief in burden of care and increased efficiency, by providing them with
telerehabilitation in their home situation instead of conventional *face-
to-face* rehabilitation.
Telerehabilitation is considered as a way of providing rehabilitation, with the
main difference that care is moved from the inpatient setting to a patient*s
home situation aimed at reducing hospitalization time and costs.
The aim of telerehabilitation is to be tailor-made, patient-centered care that
improves health care quality and better manages the care, subsequently leading
to higher patient satisfaction and adherence to improve clinical benefit.
Moreover, telerehabilitation has shown to be a valuable tool in managing
postoperative outcomes and functional progress in surgical patients. It can
serve as liaison between specialized treatment in the hospital and
interventions in primary care to promote transition of complex patients.
There is some evidence that shows positive effects on clinical outcomes in
cancer patients, cardiac patients, patients with musculoskeletal disorders and
depression, but information on this highly complex surgical population is
lacking.
Study objective
Primary Objective:
To investigate the feasibility of a 12 -week postoperative Telerehabilitation
program for patients with esophageal cancer treated with esophagectomy and
suffering from postoperative complications
Secondary Objective:
To investigate the preliminary effectiveness of Telerehabilitation on
functional recovery compared to usual care
Study design
A prospective feasibility study with historical controls will be performed.
Participants undergoing the investigational treatment will be matched to
baseline and clinical characteristics of 60 esophagectomy patients who suffered
from POC between March 2012-October 2014 receiving usual care, to assess
preliminary effectiveness.
The study will take place in a large tertiary referral center (the Academic
Medical Center in Amsterdam) and will take 12 weeks after inclusion.
Intervention
Participants will receive a 12-week Telerehabilitation intervention after
discharge from the hospital in their home situation. Before discharge from the
hospital, a physiotherapist will instruct the patient on the Telerehabilitation
intervention.
The Telerehabilitation intervention will be provided with Physitrack®
(Physitrack Limited, Brighton, UK). Physitrack® is an eHealth platform for
healthcare providers to design high-quality home exercise programs and track
patient adherence. With Physitrack, progress in home exercise programs can be
accurately monitored and adapted if necessary. In addition, built-in PROM
surveys and questionnaires allow for detailed outcome measurement analysis to
assess treatment effectiveness and optimize treatment plans for improved
outcomes and efficiencies (Physitrack, 2015). Physitrack® runs on the browser
and is available for iOS and Android as well.
The postoperative physiotherapeutic intervention with Telerehabilitation will
be aimed at improvement of functional status. The intervention will take 12
weeks of two sessions per week (24 sessions in total). The exercises are tailor
made to the patients* specific condition and needs. Patients* condition and
needs are determined 1 day prior to discharge from the hospital. To determine
the specific physiotherapy goals, the Patient Specific Complaint List will be
used 22. Intensity and frequency of the functional exercises provided with
Telerehabilitation will be determined according to the guidelines of the
American College of Sports Medicine (ACSM). During training with
Telerehabilitation, the BORG_RPE score will be used to monitor the Rate of
Perceived Exertion.
Each treatment session will take approximately 1 hour including time spent on
self-assessment, and regular communication with an experienced physiotherapist.
Trained physiotherapists will weekly monitor and adjust Telerehabilitation
treatments. The intervention is evidence based and broadly implemented in other
post surgical populations. No additional risks are to be expected with study
participation compared to usual post surgical physiotherapy treatment or at
least equal to the normal risks of treatment complications.
Study burden and risks
No additional risks are to be expected with study participation compared to
usual post surgical physiotherapy treatment or at least equal to the normal
risks of treatment complications.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Participants will be included if:
- they are aged 18 years or older,
- the primary reason of hospital stay is status after esophagectomy,
- suffering from a postoperative complication grade 3a or worse according to the Clavien-Dindo Classification,
- a postoperative length of hospital stay of more than 14 days,
- indicated for outpatient physiotherapy according to clinical expertise of hospital physiotherapist,
- having internet access at home and
- signed for informed consent.
Exclusion criteria
- unable to complete self-reported questionnaires,
- insufficiently able to read or speak the Dutch language,
- having cognitive disorders,
- or any other severe medical conditions that prevents the patient from doing exercises at home.
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 | NL58388.018.16 |