Early Rehabilitation of Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Bergen
Uppsala University
University of Agder
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01588262
First received: January 30, 2012
Last updated: November 22, 2013
Last verified: November 2013

January 30, 2012
November 22, 2013
May 2011
December 2015   (final data collection date for primary outcome measure)
Change in psychosocial status [ Time Frame: from baseline to 24 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01588262 on ClinicalTrials.gov Archive Site
Cost effectiveness of the stress-management intervention. [ Time Frame: 24 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Early Rehabilitation of Cancer Patients
Early Rehabilitation of Cancer Patients

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Colorectal Cancer
  • Lymphoma
  • Prostate Cancer
  • Testicle Cancer
Other: Stressmanagement
Individual stepped-care approach stressmanagement by specially trained counsellor
Other Names:
  • I-a
  • I-b
  • Stressmanagement counselling
    Intervention: Other: Stressmanagement
  • No Intervention: Control
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 81 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01588262
REKnr 2010/1911
Yes
Haukeland University Hospital
Haukeland University Hospital
  • University of Bergen
  • Uppsala University
  • University of Agder
Not Provided
Haukeland University Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP