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
  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

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Change in psychosocial status [ Time Frame: from baseline to 24 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: December 2015 (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:
  • I-a
  • I-b
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years to 81 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588262

Locations
Norway
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
  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: November 22, 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 July 23, 2014