Early Rehabilitation of Cancer Patients
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Purpose
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 | Intervention |
|---|---|
|
Breast Cancer Colorectal Cancer Lymphoma Prostate Cancer Testicle Cancer |
Other: Stressmanagement |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Early Rehabilitation of Cancer Patients |
- Change in psychosocial status [ Time Frame: from baseline to 24 month ] [ Designated as safety issue: No ]
- Cost effectiveness of the stress-management intervention. [ Time Frame: 24 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Stressmanagement counselling |
Other: Stressmanagement
Individual stepped-care approach stressmanagement by specially trained counsellor
Other Names:
|
| No Intervention: Control |
Eligibility| Ages Eligible for Study: | 18 Years to 81 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Karin Nordin, PhD | 0046184713487 | karin.nordin@pubcare.uu.se |
| Contact: Inger Thormodsen, MS | 004755973917 | inger.thormodsen@helse-bergen.no |
| Norway | |
| Department of Oncology and Medical Physics, Cancer center for Education and rehabilitation, Haukeland University Hospital | Recruiting |
| Bergen, Norway, 5021 | |
| Contact: Karin Nordin, PhD 0046184713487 karin.nordin@pubcare.uu.se | |
| Contact: Inger Thormodsen, MS 004755973917 inger.thormodsen@helse-bergen.no | |
More Information
No publications provided by Haukeland University Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Haukeland University Hospital |
| ClinicalTrials.gov Identifier: | NCT01588262 History of Changes |
| Other Study ID Numbers: | REKnr 2010/1911 |
| Study First Received: | January 30, 2012 |
| Last Updated: | March 19, 2013 |
| Health Authority: | Norway: Regional Ethics Commitee |
Additional relevant MeSH terms:
|
Breast Neoplasms Colorectal Neoplasms Lymphoma Prostatic Neoplasms Testicular Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Endocrine Gland Neoplasms Endocrine System Diseases Testicular Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on May 22, 2013