Adjuvant Therapy, Breast Cancer, Colorectal Cancer (CRC), Neoadjuvant Therapy, Prostate Cancer
Conditions
Keywords
sedentary behavior, behavior change, intervention, Randomized controlled trial
Brief summary
Summary Reducing sedentary behavior during treatment is important to reduce the risk of future health problems in individuals undergoing cancer treatment. Therefore, the goal of this project is with a multicenter randomised controlled design investigate whether a digital support intervention during ongoing neo- or adjuvant cancer treatment for breast, prostate or colon cancer is effective in reducing sedentary lifestyle and improving well-being in the short and long term.
Detailed description
Description of the project This project is about investigating the effect of a digital support intervention to reduce sedentary behavior in people with breast, prostate, or colorectal cancer during neo- or adjuvant cancer treatment. The digital support intervention has been developed with patients and researchers and consists of existing high-quality technology that provides support for setting and following goals. The people who use the digital support intervention also receive support from a physiotherapist to set goals for reduced sedentary time and get to choose which activities will replace the time spent sedentary. The goal of the project The goal of the project is to investigate the effects of a digital support intervention on reduced sedentary and well-being during ongoing cancer treatment, both in the short and long term. In addition, the project will study the health-economic effects, and climate benefits of using the digital support intervention. By focusing on reducing a sedentary lifestyle and replacing it with daily activities and/or physical activity, the health of individuals is expected to be positively affected in the short term through, for example, increased well-being and reduced side effects from cancer treatment, and the long term through a reduced risk of developing complications and new illness related to the cancer treatment, such as cardiovascular disease.
Interventions
BEHAVIORALDigital self-management program
The program consists of commercially available technologies, e.g. applications including behavour change techniques for reducing sedentary behavior (SB) (i.e. self-monitorization of physical activity, reminders for breaking SB/doing physical activity, and providing feedback on physical activity/breaks from SB) and a webpage containing information and tips (provided in short videos and text) regarding how to reduce SB. The participants will be receive help with setting goals for reducing time spent in sedentary/being active and help with planning for what activities to do to replace time in sedentary. Participants will then have access to the webpage and download the application to their smartphones. Follow-up meetings with the physiotherapist (digital or physical) will be conducted after 2, 8 and 12 weeks after start of intervention.
Sponsors
Mälardalen University
Region Västmanland
Uppsala University
Centrallasarettet Västerås
Uppsala University Hospital
Uppsala County Council, Sweden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals diagnosed with breast, prostate, or colorectal cancer planned for or resently started neo- or adjuvant treatment (e.g. chemotherapy, radiotherapy, endocrine treatment) at the hospitals in Uppsala and Västerås, Sweden.
Exclusion criteria
* Individuals diagnosed with dementia. * Individuals diagnosed with severe psychiatric disease. * Individuals with severe loss of vision, or communicative ability. * Individuals who cannot walk independently indoors with or without a walking aid. * Individuals completed treatment for other cancer diseases less than 12 months ago or not recovered from previous cancer treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sedentary behavior time | At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point. | The Axivity accelerometer is used for measuring the primary outcome of sedentary time, i.e. mean time spent in sedentary behavior/day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedentary behavior bouts | At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point. | The Axivity accelerometer is used for measuring sedentary bouts, i.e. mean number of bouts/day and mean bouts time/day. |
| Physical activity | At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point. | The Axivity accelerometer is used for measuring physical activity mean time/day and mean time spent in low-, moderate and high intensity physical activity. |
| Health-related quality of life | At baseline, 3-months, 6 months, 12 months and 24 months. | Patient reported health related quality of life will be assessed with European Organization for Research and Treatment of Cancer QLQ C 30 and diagnose specific modules BR23, PR26 and CR29. |
| Cancer related fatigue | At baseline, 3-months, 6 months, 12 months and 24 months. | Patient reported outcome cancer related fatigue is measured with Brief Fatigue Inventory. |
| Fear of movement | At baseline, 3-months, 6 months, 12 months and 24 months. | Patient reported outcome Fear of movement is assessed with Cancer specific Tampa Scale for Kinesiophobia. |
| Changes in health | At 3-months, 6 months, 12 months and 24 months. | Patient reported outcome Changes in health is assessed with Patient Global Impression of Change Scale. |
| Work ability | At baseline, 3-months, 6 months, 12 months and 24 months. | Selected and adapted questions from Work Ability Index are used for assessing patient reported outcome work ability. |
| Self-efficacy for reducing sedentary behavior | At baseline, 3-months, 6 months, 12 months and 24 months. | Study specific question is used for assessing patient reported outcome of Self-efficacy for reducing sedentary behavior. |
| Perceived support from peers | At baseline, 3-months, 6 months, 12 months and 24 months. | Study specific question is used for assessing patient reported outcome of Perceived support from peers. |
Countries
Sweden
Contacts
CONTACTPetra von Heideken Wågert, Professor
CONTACTAnna Henriksson
PRINCIPAL_INVESTIGATORPetra von Heideken Wågert, Professor
Mälardalen University
Outcome results
None listed