Since multiple dimensions (physical, emotional and cognitive) seem to be involved in the pathophysiology of fatigue, multidimensional approach to alleviate will probably have a synergistic effect. Previous studies supporting this assumption included…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
General fatigue, assessed with the Multidimensional Fatigue Inventory (MFI).
Secondary outcome
Secondary outcomes are quality of life, cardiopulmonary fitness, skeletal
muscle mass and strength, frailty, anxiety, depression, performance status, and
body weight. Furthermore, overall survival will be assessed.
Background summary
In gastrointestinal cancer patients, overall almost 30% of patients experience
severe fatigue while in HPB cancer the vast majority suffers from fatigue.
Generally, even after successful cancer treatment, 19 to 38% of disease-free
cancer survivors remain fatigue, which underlines its persistent character. The
cancer itself, as well as the sequelae after surgical interventions or
chemotherapy may lead to physical and psychosocial impairment in cancer
patients. As patients experience increased fear and a lower exercise tolerance
due to persistent fatigue they are at great risk of spiralling down a vicious
circle which progressively enhances these symptoms and further impairs their
quality of life and self-management capacity. In patients who have been treated
for cancer, psychotherapy and physical exercise are shown to reduce fatigue
complaints.
Study objective
Since multiple dimensions (physical, emotional and cognitive) seem to be
involved in the pathophysiology of fatigue, multidimensional approach to
alleviate will probably have a synergistic effect. Previous studies supporting
this assumption included general cancer populations or breast and colon cancer
patients, who are known for their relatively good prognosis and post-treatment
functional outcome.
The purpose of our study is to investigate whether a postoperative
rehabilitation program (solution focused psycho- and physical exercise therapy)
improves fatigue (primary outcome) and quality of life, muscle mass, and
physical fitness (secondary outcomes) in cancer patients operated for HPB
malignancies, known to have a more dismal prognosis.
Study design
In this multicentre randomized controlled trial, patients will randomly be
assigned to the treatment (rehabilitation program) or control (usual care)
group in the four participating centres. After hospital discharge, the
treatment group will undergo a supervised, tailored exercise program aimed at
both cardiorespiratory fitness (aerobic training) and muscle strength
(resistance training) twice a week during twelve weeks. Furthermore, one hour
solution focused therapy is offered every other week. The primary outcome will
be fatigue, assessed using the Multidimensional Fatigue Inventory assessed 6
and 12 months after surgery. Secondary outcomes are quality of life,
cardiopulmonary fitness, skeletal muscle mass and strength, frailty, anxiety,
depression, and body weight, assessed preoperatively, at the start and end of
the rehabilitation program and six and twelve months after surgery. Validated
tests are used to assess these parameters. Furthermore, an effect of the
intervention on overall survival will be investigated.
Intervention
rehabilitation program consisting of physical exercise therapy, psychotherapy
and dietary consultation.
Study burden and risks
risk associated with participation:
- potential increase in fatigue.
Furthermore participation will imply:
- that the patient will spend extra time
- that the patient has to fill in potentially confronting questionaires
- that the patient will have to adhere to the instructions and additional
meetings
's Gravendijkwal 230
Rotterdam 3015CE
NL
's Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
* Undergoing curative intent surgery for HPB malignancies. Liver surgery will be defined as major if a left or right (extended) hemihepatectomy or if 3 or more segments are resected and minor if less than 3 segments are resected.
* Clinically suspect or histologically confirmed liver, bile duct, pancreatic carcinoma or invasive IPMN;
* Life expectancy of at least six (6) months;
* Resection performed
* Fatigue score * 4 on a numeric rating scale (NRS) with scores of 0 to 10
* Able to read and understand the Dutch language;
* Written informed consent.
Exclusion criteria
- Bone metastases or other high risk of fracture;
- Not able to perform basic activities of daily living (ECOG *3);
- Decompensated heart disease, uncontrolled hypertension (systolic blood pressure > 200 mmHg or diastolic blood pressure > 110 mmHg), heart failure (NYHA Class II or greater) or chronic obstructive pulmonary disease causing fatigue;
- Living in nursing homes;
- Cognitive impairment;
- BMI <15 kg2/m2, >5% weight loss per month or other health problems that would not allow physical exercise training;
- Anxiety or depression requiring psychiatric consultation;
- Cancer treatment in the previous 3 years (except basal skin cancer);
- Participation in other studies containing elements of physical exercise or psychological therapy.
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 | NL64296.078.17 |