Clinical trial NCT01588262: Early Rehabilitation of Cancer Patients
Official title: Early Rehabilitation of Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Lymphoma
Prostate Cancer
Testicle Cancer
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: Uppsala University
name: University of Agder
First posted: 2012-04-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in psychosocial status
timeFrame: from baseline to 24 month
Secondary outcomes:
measure: Cost effectiveness of the stress-management intervention.
timeFrame: 24 month
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Department of Oncology and Medical Physics, Cancer center for Education and rehabilitation, Haukeland University Hospital
Study officials:
References:
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.