Stress Management in Breast Cancer Patients

NCT01555645 | Completed DMC

• 3 other identifiers: K2010-70X-21412-01-3CAN 2009/25CAN 2011/08
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 3

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. 1.Studying the prevalence of stress related symptoms in female patients with breast cancer
2. 2.Testing the use of two short screening instruments to identify women at risk for developing long-standing stress symptoms
3. 3.Studying the level and intensity of stress management interventions required to achieve increased well-being, using a stepped-care approach.
4. 4.Studying the effects of interventions based on cognitive behavior therapy, delivered individually or in a group format.

Conditions

Breast Cancer; Stress

Keywords

Breast cancer; Stress management; Stepped care; Randomized

Outcome Measures

Primary Outcomes (1)

• Psychosocial aspect

  Intrusion, Avoidance, Anxiety, Depression, Quality of life, Fatigue, Daily stress

  Changes in psychosocial aspects from baseline to 12 months post diagnosis

Secondary Outcomes (2)

• Cost-Utility Analysis

  12 month

• Patient satisfaction

  3 month, after intensive intervention and 12 month

Study Arms (2)

Stress management Individual format

EXPERIMENTAL

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.

Behavioral: Stress management, in two steps

Stress management Group format

EXPERIMENTAL

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.

Behavioral: Stress management, in two steps

Interventions

Stress management, in two steps 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; Stress management Individual format

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• ongoing psychiatric condition
• language deficiencies in Swedish

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (3)

Unknown Facility

Falun, Sweden

Location

Unknown Facility

Gävle, Sweden

Location

Unknown Facility

Uppsala, Sweden

Location

Related Publications (2)

• 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.

  PMID: 26632880 DERIVED

• 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.

  PMID: 22559200 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Karin Nordin, Prof

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 15, 2012
• Study Start: May 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 4, 2015

Record last verified: 2015-12

Locations

SE (3)