Adverse Effects, Anxiety, Depression, Health Behavior
Conditions
Keywords
neoplasms, rehabilitation, anxiety, depression, adverse effects, health behavior
Brief summary
The purpose of this study is to examine if a psychosocial intervention including a nurse navigator and systematic symptom screening may reduce psychological and physical symptoms as well as health behavior after breast cancer.
Detailed description
In this pilot study with a randomized controlled trial design, we examine the effect of an intervention optimizing and integrating rehabilitation for breast cancer on psychological and physical symptoms as well as health behavior after breast cancer. In the intervention group, we systematically screen for psychological and physical symptoms as well as health behavior (smoking alcohol and physical activity) not in line with the recommendations. Patients who screen positive are offered a sequence of sessions with a navigator nurse who monitor rehabilitation needs, supports the patient, educate in self-management of symptoms and refer to existing rehabilitation services as well as to up to 6 free sessions with a psychologist specialized in cancer patients. The rehabilitation services that the nurse refers to include several hospital departments and municipality services as well as general practice and by thorough follow-up on the patients use of these, the intervention aims at developing an integrated treatment and rehabilitation trajectory. The control group receives standard care.
Interventions
OTHERScreening-based nurse navigation
Screening-based nurse navigation for breast cancer rehabilitation
Sponsors
TRYG Foundation
Rigshospitalet, Denmark
Center for Kræft og Sundhed
Danish Cancer Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of primary breast cancer at Breast Oncology Clinic, Rigshospitalet, Copenhagen, Denmark * lives in Copenhagen municipality * score ≥7 on distress thermometer * able to read and understand Danish * not pregnant * expected survival more than 6 months * physically able to participate in rehabilitation * no severe psychiatric disease demanding treatment * no severe cognitive problems (e.g. dementia or confusion)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychological distress | 6 and 12 months | Difference in change in psychological distress between patients in the intervention and control group.Psychological distress wil be measured using the Distress Thermometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety and depression | 6 and 12 months | Difference in change in patient reported anxiety and depression between patients in the intervention and control group. Anxiety and depresison will be measured using the Hospital Anxiety and Depression scale (HADS). |
| Smoking | 6 and 12 months | Difference in change in patient reported cigarette smoking measured in grams per day between patients in intervention and control group. |
| Alcohol consumption | 6 and 12 months | Difference in change in patient reported alcohol consumption measured in grams per day between patients in intervention and control group. |
| Health related quality of life | 6 and 12 months | Difference in change in patient reported health related quality of life between patients in the intervention and control group. Health related quality of life will be measured using the European Organization for Research and Treatment of Cancer quality of life questionnaire EORTC QLQ C30 and the EORTC BR23 including subscales. |
| Physical activity | 6 and 12 months | Difference in change in patient reported physical activity between patients in intervention and control group. |
| Use of rehabilitation services | 6 and 12 months | Difference in change in patient reported use of rehabilitation services between patients in intervention and control group. |
| Body mass index | 6 and 12 months | Difference in change in patient reported body masss index between patients in intervention and control group. |
Countries
Denmark
Outcome results
None listed