Early Rehabilitation of Cancer Patients
Primary Purpose
Breast Cancer, Colorectal Cancer, Lymphoma
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Stressmanagement
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed with breast cancer,
- colorectal cancer,
- lymphoma,
- prostate cancer or testicle cancer and scheduled for adjuvant and/or curative treatment in the form of chemotherapy, radiation therapy and/or hormonal therapy at the Department of Oncology and Medical physics, Haukeland University Hospital, (Dept. of Oncology) Bergen,
- residence in Rogaland, Hordaland and Sogn and fjordane county council,
- initial treatment for cancer
Exclusion Criteria:
- An ongoing psychiatric condition,
- language deficiencies in Norwegian,
- surgery for prostate cancer (only applies for prostate cancer) patients),
- men with breast cancer,
- live in nursing homes,
- previous cancer,
- treated for cancer earlier,
- already implemented oncological treatment,
- not self-reliant
Sites / Locations
- Department of Oncology and Medical Physics, Cancer center for Education and rehabilitation, Haukeland University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Stressmanagement counselling
Control
Arm Description
Outcomes
Primary Outcome Measures
Change in psychosocial status
Secondary Outcome Measures
Cost effectiveness of the stress-management intervention.
Full Information
NCT ID
NCT01588262
First Posted
January 30, 2012
Last Updated
October 12, 2015
Sponsor
Haukeland University Hospital
Collaborators
University of Bergen, Uppsala University, University of Agder
1. Study Identification
Unique Protocol Identification Number
NCT01588262
Brief Title
Early Rehabilitation of Cancer Patients
Official Title
Early Rehabilitation of Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
University of Bergen, Uppsala University, University of Agder
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A life threatening disease such as cancer may lead to post traumatic stress disorder, and even when reporting low levels of side-effects from cancer disease and treatment, 80% report high levels of stress symptoms. The purpose of the present randomised controlled trial is to examine the psychosocial effects of a stress management intervention based on cognitive behaviour therapy and with focus on increased physical activity in patients with various cancer diagnoses using a stepped-care approach. When using a stepped-care approach it is possible to study the level and intensity of stress management intervention required to achieve increased well-being. A cost-utility analysis will also be performed. 300 adult patients with a recent diagnosis of breast-, colorectal- prostate, testicular cancer or lymphoma and scheduled for adjuvant and/or curative oncologic treatment at Haukeland University Hospital, will be consecutively included in the prospective intervention study. The patients will be randomized to intervention or control. In step 1, all patients in the intervention group (I-a) will receive 2 counselling sessions. Patients who report clinically significant levels of stress, such as intrusive thoughts/avoidance behaviour (measured by Impact of Event Scale) and/or worry and depressions (measured by Hospital and Depression Scale) will be included in Step 2 (I-b) and include another 4-7 counselling sessions. There will also be a focus on motivating to increase physical activity level. Both the intervention (I) and control group (C) are allowed to take part in the common rehabilitation program with patient education and physical training. Data will be collected with self-reported standardized questionnaires. Objectively measures of physical activity level, sleep and daily energy expenditure are recorded with SenseWear™ Pro3 Armband. Measure point is at inclusion and than after 6 week, 4, 8, 12 and 24 month.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer, Lymphoma, Prostate Cancer, Testicle Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stressmanagement counselling
Arm Type
Other
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Stressmanagement
Other Intervention Name(s)
I-a, I-b
Intervention Description
Individual stepped-care approach stressmanagement by specially trained counsellor
Primary Outcome Measure Information:
Title
Change in psychosocial status
Time Frame
from baseline to 24 month
Secondary Outcome Measure Information:
Title
Cost effectiveness of the stress-management intervention.
Time Frame
24 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed with breast cancer,
colorectal cancer,
lymphoma,
prostate cancer or testicle cancer and scheduled for adjuvant and/or curative treatment in the form of chemotherapy, radiation therapy and/or hormonal therapy at the Department of Oncology and Medical physics, Haukeland University Hospital, (Dept. of Oncology) Bergen,
residence in Rogaland, Hordaland and Sogn and fjordane county council,
initial treatment for cancer
Exclusion Criteria:
An ongoing psychiatric condition,
language deficiencies in Norwegian,
surgery for prostate cancer (only applies for prostate cancer) patients),
men with breast cancer,
live in nursing homes,
previous cancer,
treated for cancer earlier,
already implemented oncological treatment,
not self-reliant
Facility Information:
Facility Name
Department of Oncology and Medical Physics, Cancer center for Education and rehabilitation, Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
23294513
Citation
Arving C, Thormodsen I, Brekke G, Mella O, Berntsen S, Nordin K. Early rehabilitation of cancer patients - a randomized controlled intervention study. BMC Cancer. 2013 Jan 7;13:9. doi: 10.1186/1471-2407-13-9.
Results Reference
derived
Learn more about this trial
Early Rehabilitation of Cancer Patients
We'll reach out to this number within 24 hrs