Clinical trial NCT06719206: Reduce Sedentary Behavior During Cancer Treatment - the RedSedCan Study
Official title: Reduce Sedentary Behavior During Cancer Treatment - the RedSedCan Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer (CRC)
Prostate Cancer
Neoadjuvant Therapy
Adjuvant Therapy
Keywords: sedentary behavior
behavior change
intervention
Randomized controlled trial
Lead sponsor: Mälardalen University
Sponsor class: OTHER
Collaborators: name: Uppsala University
name: Uppsala University Hospital
name: Region VÃ¤stmanland
name: Centrallasarettet VÃ¤sterÃ¥s
name: Region Uppsala
First posted: 2024-12-05
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 self-management program 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 self-management program to reduce sedentary behavior in people with breast, prostate, or colorectal cancer during neo- or adjuvant cancer treatment. The self-management program 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 self-help program 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 self-management program 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 self-management program. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sedentary behavior time
timeFrame: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.
Secondary outcomes:
measure: Sedentary behavior bouts
timeFrame: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.
measure: Physical activity
timeFrame: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.
measure: Health-related quality of life
timeFrame: At baseline, 3-months, 6 months, 12 months and 24 months.
measure: Health-related quality of life
timeFrame: At baseline, 3-months, 6 months, 12 months and 24 months.
measure: Cancer related fatigue
timeFrame: At baseline, 3-months, 6 months, 12 months and 24 months.
measure: Fear of movement
timeFrame: At baseline, 3-months, 6 months, 12 months and 24 months.
measure: Changes in health
timeFrame: At 3-months, 6 months, 12 months and 24 months.
measure: Work ability
timeFrame: At baseline, 3-months, 6 months, 12 months and 24 months.
measure: Self-efficacy for reducing sedentary behavior
timeFrame: At baseline, 3-months, 6 months, 12 months and 24 months.
measure: Perceived support from peers
timeFrame: At baseline, 3-months, 6 months, 12 months and 24 months.
Other outcomes:
measure: Demographic variables
timeFrame: Baseline
measure: Diagnoses
timeFrame: At baseline
measure: Cancer treatment
timeFrame: At baseline, 3-months, 6 months, 12 months and 24 months.
measure: Health care costs
timeFrame: At baseline, 3-months, 6 months, 12 months and 24 months.
measure: Costs of intervention
timeFrame: At baseline, 3-months, 6 months, 12 months and 24 months.
measure: Sick leave
timeFrame: At baseline, 3-months, 6 months, 12 months and 24 months.
measure: Adherence
timeFrame: At baseline, 3-months, 6 months, 12 months and 24 months.
measure: Green house gas emissions
timeFrame: At baseline, 3-months, 6 months, 12 months and 24 months.
Locations:
Study officials:
affiliation: Mälardalen University
name: Petra von Heideken Wågert, Professor
role: PRINCIPAL_INVESTIGATOR
References: