Cancer SurvivorsRPACNCT04245943
Rehabilitation - Physical Activity and Coping
A study testing Exercise training in people with Cancer Survivors, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The project is a non-randomized intervention study with group-based physical exercise. Cancer survivors who have participated in the rehabilitation program at the Center for Education and Rehabilitation are included in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivors
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 22 Jul 2019to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years
- Women and men
- Regardless of cancer diagnosis
- Resident in Bergen municipality
- Finishes their rehabilitation at The Cancer Center for Education and Rehabilitation spring/summer 2019.
Who cannot join
- Patients who do not speak or understand Norwegian
- Unable to express themselves in writing
- Unable to perform basic daily tasks
- Display cognitive disorder or severe emotional instability
- Suffer from other debilitating illnesses / conditions that may inhibit physical exercise (heart failure, chronic obstructive pulmonary disease, orthopedic conditions, neurological disorders or the like) will be excluded from the study. -
Trial locations and contacts
1 site in 1 country.
About this study
The project is a non-randomized intervention study with group-based physical exercise. Cancer survivors who have participated in the rehabilitation program at the Center for Education and Rehabilitation are included in the study.
The cancer and cancer treatment have led to patients struggling with physical, mental and social late effects which prevent them from functioning in everyday life and return to work. The purpose of the project is to investigate whether one municipal group training measure can help to lower the threshold for the user to maintain good exercise habits and return to work / everyday life, as well as the effect on the user's physical form and quality of life and the transition between health level and the body itself measure.
- Conditions
- Cancer Survivors
- Being tested
- Exercise training
- Keywords
- Rehabilitation, Physical exercise, Return to work, Fatigue, Cancer survivors
- Medical subject headings
- Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
18 weeks supervised strength and aerobic exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 18 weeks supervised strength and aerobic exercise training Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objectively recorded physical activity level
Change in objectively recorded physical activity level, measured with the SenseWear ™ Mini Armband (SWA) (BodyMedia Inc. Pittsburgh, PA, USA) as average minutes of moderate- to vigorous intensity physical activity (MVPA) from before intervention to after completion of the intervention.
Measured: 18 weeks
Secondary outcomes (4)
Change in maximal oxygen uptake measured by VO2max
Change in VO2max, measured by a maximal incremental exercise test on a treadmill, from before training intervention to post training intervention.
Measured: 18 weeks
Change in maximal strength
Change in 1 repetition maximum strength in upper and lower body measured from before intervention and after completion of the intervention.
Measured: 18 weeks
Change in quality of life measured by Short Form Health Survey (SF-36)
Change in scores on the Short Form Health Survey (SF-36) from before intervention to after completion of the intervention.
Measured: 18 weeks
Change in fatigue scores using the Chalder Fatigue Questionaire (FQ)
Change in scores on the Chalder Fatigue Questionaire (FQ) from before intervention to after completion of the intervention.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start22 Jul 2019
- Primary completion26 Aug 2019
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecilia Arving, PhD, Study director, Helse Bergen, Cancer Center for Education and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245943
- Sponsor's protocol ID
- 2019/620
- Acronym
- RPAC
- Status last verified
- Feb 2024
- First submitted
- 16 Jan 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) that underlie results in a publication are to be shared with two master students and their professors/supervisors/researchers who take part in the study.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation - Physical Activity and Coping
- ClinicalTrials.gov ID
- NCT04245943
- Acronym / sponsor ID
- RPAC / 2019/620
- Conditions
- Cancer Survivors
- Keywords
- Rehabilitation, Physical exercise, Return to work, Fatigue, Cancer survivors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project is a non-randomized intervention study with group-based physical exercise. Cancer survivors who have participated in the rehabilitation program at the Center for Education and Rehabilitation are included in the study.
The cancer and cancer treatment have led to patients struggling with physical, mental and social late effects which prevent them from functioning in everyday life and return to work. The purpose of the project is to investigate whether one municipal group training measure can help to lower the threshold for the user to maintain good exercise habits and return to work / everyday life, as well as the effect on the user's physical form and quality of life and the transition between health level and the body itself measure.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise training18 weeks supervised strength and aerobic exercise training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years
- Women and men
- Regardless of cancer diagnosis
- Resident in Bergen municipality
- Finishes their rehabilitation at The Cancer Center for Education and Rehabilitation spring/summer 2019.
Key exclusion criteria (5 listed)
- Patients who do not speak or understand Norwegian
- Unable to express themselves in writing
- Unable to perform basic daily tasks
- Display cognitive disorder or severe emotional instability
- Suffer from other debilitating illnesses / conditions that may inhibit physical exercise (heart failure, chronic obstructive pulmonary disease, orthopedic conditions, neurological disorders or the like) will be excluded from the study. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise training18 weeks supervised strength and aerobic exercise training. | Behavioural | Exercise |
Primary outcome
Objectively recorded physical activity level
Time frame: 18 weeks
Change in objectively recorded physical activity level, measured with the SenseWear ™ Mini Armband (SWA) (BodyMedia Inc. Pittsburgh, PA, USA) as average minutes of moderate- to vigorous intensity physical activity (MVPA) from before intervention to after completion of the intervention.
4 secondary outcomes
Change in maximal oxygen uptake measured by VO2max
Time frame: 18 weeks
Change in maximal strength
Time frame: 18 weeks
Change in quality of life measured by Short Form Health Survey (SF-36)
Time frame: 18 weeks
Change in fatigue scores using the Chalder Fatigue Questionaire (FQ)
Time frame: 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) that underlie results in a publication are to be shared with two master students and their professors/supervisors/researchers who take part in the study.
Related trials for Cancer Survivors
Active, not recruiting
A Collaborative Intervention for Improving Cancer Pain Management in Cancer Survivors
Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
Recruiting
A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
Survivorship
RecruitingObservational study
Breast Cancer Rehabilitation Needs and Service Uptake
Breast Cancer, Cancer Survivorship
Active, not recruitingPhase 3
Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia
Breast Cancer, Arthralgia
RecruitingObservational study
Association Between Exercise, Patient-Reported Outcomes, and Clinical Events in Adult Cancer Survivors
Survivorship, Recurrent
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilia Arving, PhD study director
Helse Bergen, Cancer Center for Education and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Cancer Survivors, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objectively recorded physical activity level (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.