Early Rehabilitation of Cancer Patients

NCT ID: NCT01588262

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-08-31

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.

Conditions

Breast Cancer; Colorectal Cancer; Lymphoma; Prostate Cancer; Testicle Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Stressmanagement counselling

Group Type: OTHER

Stressmanagement

Intervention Type: OTHER

Individual stepped-care approach stressmanagement by specially trained counsellor

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stressmanagement

Individual stepped-care approach stressmanagement by specially trained counsellor

Intervention Type: OTHER

Other Intervention Names

I-a; I-b

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bergen

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: collaborator

University of Agder

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Oncology and Medical Physics, Cancer center for Education and rehabilitation, Haukeland University Hospital

Bergen, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 23294513 (View on PubMed)

Other Identifiers

REKnr 2010/1911

Identifier Type: -

Identifier Source: org_study_id