|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
7 June 2021 |
|
Main ID: |
NCT02332317 |
|
Date of registration:
|
30/12/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Early, Integrated, Specialized Palliative Rehabilitation
|
|
Scientific title:
|
A Randomized, Controlled Phase III Study of Integrated, Specialized Palliative Rehabilitation for Patients With Newly Diagnosed Non-resectable Cancer. |
|
Date of first enrolment:
|
December 2014 |
|
Target sample size:
|
301 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02332317 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Denmark
| | | | | | | |
|
Contacts
|
|
Name:
|
Henrik Jensen, Assoc. prof. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Vejle Hospital |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
Participants must:
- be diagnosed with non-resectable cancer less than 8 weeks before inclusion. For
patients with prostate cancer they must be refered to systemic oncology treatment for
the first time less than 8 weeks before inclusion.
- be fit to receive standard oncology treatment and accepting treatment
- read and understand Danish
- sign informed consent
Exclusion Criteria:
- contact with a specialized palliative unit within the last year before inclusion
- unability to cooperate in the study
- missing informed consent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Advanced Cancer
|
|
Intervention(s)
|
|
Behavioral: Palliative rehabilitation
|
|
Primary Outcome(s)
|
|
Effect of the intervention on "The Primary Problem" chosen by the patient.
[Time Frame: 6 and 12 weeks]
|
|
Secondary Outcome(s)
|
|
Effect of the intervention on worries and symptoms of anxiety and depression
[Time Frame: 6 and 12 weeks]
|
|
Effect of the intervention on all symptoms and problems present in the EORTC-QLQ-C30 Questionnaire
[Time Frame: 6 and 12 weeks]
|
|
Economic consequences
[Time Frame: 3 months after last data collection]
|
|
All cause mortality
[Time Frame: 3 months after last data collection]
|
|
Secondary ID(s)
|
|
Pal-Rehab
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|