Stress Management in Breast Cancer Patients

NCT ID: NCT01555645

Last Updated: 2015-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 466 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2014-09-30

Brief Summary

The purpose of this study within Caring sciences is to identify women with breast cancer who have stress symptoms and to offer these women appropriate care to reduce stress and increase well-being. This will be achieved by

1. Studying the prevalence of stress related symptoms in female patients with breast cancer

2. Testing the use of two short screening instruments to identify women at risk for developing long-standing stress symptoms

3. Studying the level and intensity of stress management interventions required to achieve increased well-being, using a stepped-care approach.

4. Studying the effects of interventions based on cognitive behavior therapy, delivered individually or in a group format.

The hypothesis is that half of the individuals assigned to a low intensity intervention will be significantly improved after treatment. For individuals who continue to have symptoms after low intensity treatment it is hypothesized that continued treatment in a group setting with high intensity interventions will be more cost-effective. In addition the assumption is that reduction of stress symptoms in women with breast cancer will lead to a reduction in socio-economic costs.

Conditions

Breast Cancer; Stress

Study Design

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

Study Groups

Stress management Individual format

The methods and techniques will be the same as those used in the group intervention. The first session will be used for a detailed assessment of the individual's psychosocial problems, as used in earlier studies. The sessions will last 45 - 60 minutes. The number of sessions will depend on the individual patient's problems and the joint assessment made by the patient and nurse together. The total number of sessions will be at least 4, with a maximum of 8. The contents of the sessions are Session 1: Assessment, Session 2: Analysis of diary (self-registration) and suggestions for problem management, Session 3: Evaluation of problem management skills Session 4: Follow-up and conclusion of the intervention. When necessary Sessions 5 -8 will address specific obstacles and continued practice.

Group Type: EXPERIMENTAL

Stress management, in two steps

Intervention Type: BEHAVIORAL

All patients start at the first step of the intervention program with a two hours psychoeducation in stress management. Patients, who don't report a decrease in stress related symptoms, after the first step will be offered an intensive stress management, either in individual or group format. Components included in the intervention concern 1) basic knowledge about cancer, treatment, healthy living and stress reactions, 2) self-awareness with help of diary for thoughts, feelings and behavior 3) instruction in various techniques on how to express negative feelings, how to communicate with others more effectively, how to change behaviors related to stress 4) training these techniques in real-life situations 5) cognitive restructuring 6) spirituality, derived from cognitive behavior therapy.

Stress management Group format

Participants will meet for 2 hours every week for a total of 20 hours. In the intervals between the group meetings patients will be asked to do homework. Homework entails practicing problem-solving techniques, keeping a diary, practicing relaxation or physical activities. Each group meeting has a specific subject, i.e. What is stress and stress behaviors, Stress related symptoms, How to manage anger and negative thoughts, Self-registrations and behavioral changes, Future perspectives, Cancer, stress and relations, Expectations and demands, Body, pleasure and sexuality.

Group Type: EXPERIMENTAL

Stress management, in two steps

Intervention Type: BEHAVIORAL

All patients start at the first step of the intervention program with a two hours psychoeducation in stress management. Patients, who don't report a decrease in stress related symptoms, after the first step will be offered an intensive stress management, either in individual or group format. Components included in the intervention concern 1) basic knowledge about cancer, treatment, healthy living and stress reactions, 2) self-awareness with help of diary for thoughts, feelings and behavior 3) instruction in various techniques on how to express negative feelings, how to communicate with others more effectively, how to change behaviors related to stress 4) training these techniques in real-life situations 5) cognitive restructuring 6) spirituality, derived from cognitive behavior therapy.

Interventions

Stress management, in two steps

All patients start at the first step of the intervention program with a two hours psychoeducation in stress management. Patients, who don't report a decrease in stress related symptoms, after the first step will be offered an intensive stress management, either in individual or group format. Components included in the intervention concern 1) basic knowledge about cancer, treatment, healthy living and stress reactions, 2) self-awareness with help of diary for thoughts, feelings and behavior 3) instruction in various techniques on how to express negative feelings, how to communicate with others more effectively, how to change behaviors related to stress 4) training these techniques in real-life situations 5) cognitive restructuring 6) spirituality, derived from cognitive behavior therapy.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• over the age of 18
• a recent diagnosis of breast cancer
• scheduled for adjuvant treatment in Falun, Gävle or Uppsala (Sweden)

Exclusion Criteria

• ongoing psychiatric condition
• language deficiencies in Swedish

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karin Nordin, Prof

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Falun, , Sweden

Gävle, , Sweden

Uppsala, , Sweden

Countries

Sweden

References

Hellerstedt-Borjesson S, Nordin K, Fjallskog ML, Holmstrom IK, Arving C. Women Treated for Breast Cancer Experiences of Chemotherapy-Induced Pain: Memories, Any Present Pain, and Future Reflections. Cancer Nurs. 2016 Nov/Dec;39(6):464-472. doi: 10.1097/NCC.0000000000000322.

Reference Type: DERIVED

PMID: 26632880 (View on PubMed)

Nordin K, Rissanen R, Ahlgren J, Burell G, Fjallskog ML, Borjesson S, Arving C. Design of the study: how can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care. BMC Cancer. 2012 May 4;12:167. doi: 10.1186/1471-2407-12-167.

Reference Type: DERIVED

PMID: 22559200 (View on PubMed)

Other Identifiers

CAN 2009/25

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CAN 2011/08

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

K2010-70X-21412-01-3

Identifier Type: -

Identifier Source: org_study_id