Breast Neoplasms, Psychological Distress, Rehabilitation
Conditions
Brief summary
This study aims to evaluate the effects of an intervention based on systematic screening of psychological distress as the basis for individualised support and rehabilitation following primary breast cancer surgery focusing on psychological , physical and health-economics outcomes. The aim is also to illuminate patients' and relatives' experiences and need of support during the rehabilitation .
Detailed description
Breast cancer survivors are known to suffer from remaining problems from their treatment after surgery. Despite numerous of studies evaluating the effect of various rehabilitation programs it is know that patients often receive rehabilitation recommendations that are general rather than individualised to their needs. The large amount of studies within this area have contributed to knowledge about potential beneficial rehabilitation interventions for these patients but there is still a lack of knowledge about how patients specific needs of rehabilitation can be identified and how health care can adjust and individualize rehabilitation to optimize rehabilitation. This study aims to evaluate the effects of an intervention based on systematic screening of psychological distress as the basis for individualised support and rehabilitation following primary breast cancer surgery focusing on psychological , physical and health-economics outcomes. The aim is also to illuminate patients' and relatives' experiences and need of support during the rehabilitation.
Interventions
OTHERIndividualised rehabilitation
Patients will get access/support to individualised rehabilitation based on their needs identified through the distress thermometer
OTHERCare as usual
Patients will get care as usual
Sponsors
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
RCT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergone treatment for primary breast cancer * ≤18 years old * Ability to communicate in Swedish * Written informed consent
Exclusion criteria
* Recurrent disease * Palliative diagnosis * Pregnancy * Prior history of breast cancer * Inability to participate in the study due to cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychological Distress | Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time. | Psychological Distress measured by the Distress thermometer. A instrument that the patients answer themselves measuring the level of distress and the potential problems the may have. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Information needs | Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time. | The INFO35 instrument is developed by the EORTC and measures the patients perception of information received |
| Resilience | Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time. | Conner-Davidsson Resilience scale (CD-RISC) will be used to measure patients resilience trough 25 questions ranging from 0-4. Lower scores indicates more problems |
| Life style changes | Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time. | Life style changes will be measured by single items concerning exercise (amount hours of physical activity/day), Body mass index (based on weight and length), alcohol (units/glasses/ day) and tobacco habits (yes/no) |
| General Quality of life | Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time. | The instrument QLQ-C30 is developed by the EORTC (European Organization for Research and Treatment of Cancer) and measurers quality of life |
| Breast cancer specific quality of life | Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time. | The instrument QLQ-BR23 is developed by the EORTC (European Organization for Research and Treatment of Cancer) and measurers diagnose specific quality of life |
| Satisfaction with care | Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time. | Singel items focusing on satisfaction with care |
| Health economics | Evaluations will be conducted after data collection is finished. 6 months and one year after inclusion. | Cost-effectiveness analysis will be performed by evaluations of health care consumption (number of and total cost of health care visits) and by evaluating sickness absence (number of days) |
Countries
Sweden
Contacts
Primary ContactMarlene Malmström, Ass professor
Backup ContactUlrika Olsson Möller, PhD
Outcome results
None listed