Early Rehabilitation of Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01588262
Recruitment Status : Completed
First Posted : April 30, 2012
Last Update Posted : October 14, 2015
University of Bergen
Uppsala University
University of Agder
Information provided by (Responsible Party):
Haukeland University Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Lymphoma Prostate Cancer Testicle Cancer Other: Stressmanagement Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Early Rehabilitation of Cancer Patients
Study Start Date : May 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Stressmanagement counselling Other: Stressmanagement
Individual stepped-care approach stressmanagement by specially trained counsellor
Other Names:
  • I-a
  • I-b

No Intervention: Control

Primary Outcome Measures :
  1. Change in psychosocial status [ Time Frame: from baseline to 24 month ]

Secondary Outcome Measures :
  1. Cost effectiveness of the stress-management intervention. [ Time Frame: 24 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01588262

Department of Oncology and Medical Physics, Cancer center for Education and rehabilitation, Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Uppsala University
University of Agder

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Haukeland University Hospital Identifier: NCT01588262     History of Changes
Other Study ID Numbers: REKnr 2010/1911
First Posted: April 30, 2012    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Colorectal Neoplasms
Testicular Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders