Clinical trial NCT03434717: Optimized Rehabilitation Following Primary Breast Cancer Surgery
Official title: Optimized Rehabilitation Following Primary Breast Cancer Surgery - Systematic Screening as a Tool for Individualised Rehabilitation: Study Protocol for the RE-SCREEN Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rehabilitation
Breast Neoplasms
Psychological Distress
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 643
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Psychological Distress
timeFrame: 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.
Secondary outcomes:
measure: General Quality of life
timeFrame: 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.
measure: Information needs
timeFrame: 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.
measure: Resilience
timeFrame: 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.
measure: Life style changes
timeFrame: 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.
measure: Health economics
timeFrame: Evaluations will be conducted after data collection is finished. 6 months and one year after inclusion.
measure: Breast cancer specific quality of life
timeFrame: 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.
measure: Satisfaction with care
timeFrame: 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.
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne university hospital
Study officials:
affiliation: Lund university, department of health siences, Lund
name: Marlene Malmström, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olsson Moller U, Ryden L, Malmstrom M. Systematic screening as a tool for individualized rehabilitation following primary breast cancer treatment: study protocol for the ReScreen randomized controlled trial. BMC Cancer. 2020 May 29;20(1):484. doi: 10.1186/s12885-020-06815-3.