Young Adult, Cancer, Physical ActivityNCT03000166
Step-Up Intervention for Self-Management of Fatigue in Young Adults Receiving Chemotherapy
A study testing Step-Up Intervention in people with Young Adult, Cancer, Physical Activity, run by University of Wisconsin, Milwaukee at 2 sites in United States.
Trial summary
The purpose of the study is to determine the impact of a physical activity intervention on the self-management of fatigue in young adults receiving chemotherapy. Half of the participants will receive an intervention which includes education and resources to set physical activity goals and monitor progress toward goals. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Young Adult, Cancer, Physical Activity
- What is being tested?
- Step-Up Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2017to 16 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- have a diagnosis of cancer;
- are within the first two months of a chemotherapy regimen that will last at least another 3 months;
- are ambulatory without assistance;
- have written consent from their physician to participate;
- have the ability to understand English;
- have access to a computer and the Internet.
Who cannot join
- symptoms of uncontrolled cardiopulmonary disease, neurological disease
- delayed wound healing
- high risk of bone fracture
- pre-existing peripheral neuropathy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Froedtert Hospital
Milwaukee, Wisconsin, 53226
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53233
About this study
The purpose of the study is to determine the impact of a physical activity intervention on the self-management of fatigue in young adults receiving chemotherapy. Half of the participants will receive an intervention which includes education and resources to set physical activity goals and monitor progress toward goals.
Read the detailed description
Interventions to increase physical activity have been shown to relieve fatigue in patients receiving chemotherapy, but no studies have tested a physical activity intervention to improve fatigue in young adults receiving chemotherapy. This study will determine the impact of a physical activity intervention on the self-management process variables of self-efficacy and self-regulation and their relationships to physical activity and fatigue severity in young adults receiving chemotherapy.
- Conditions
- Young Adult, Cancer, Physical Activity
- Being tested
- Step-Up Intervention
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step-Up InterventionBehavioural
Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.
| Study group | Role | What they receive |
|---|---|---|
| Step-Up Intervention Group | Experimental | Participants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity. Receives: Behavioral: Step-Up Intervention |
| Attention Control Group | No intervention | Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy for Physical Activity
Physical Activity Assessment Inventory (Haas \& Northam, 2010) The scale measures confidence to be physically active under various conditions. Scores range from 0=cannot do at all to 100=certain can do.
Measured: Completion of post-study measures (average 15 weeks)
Self-regulation of Physical Activity
Index of Self-Regulation (Yeom et al., 2011) The scale measures self-regulation skills, including processing information, monitoring performance, and taking action to meet goals. Scores range from 1 to 6, with higher scores indicating agreement that the individual has these skills.
Measured: Completion of post-study measures (average 15 weeks)
Secondary outcomes (2)
Steps Per Day
Measured by accelerometer
Measured: Completion of post-study measures (average 15 weeks)
Fatigue Severity
Measured with PROMIS - Fatigue Short Form Fatigue severity is measured over the past 7 days from 1=never to 5=always. The raw scores are converted to T-scores, where 50=average fatigue in the general population. Higher scores indicate greater fatigue severity.
Measured: Completion of end-of-study measures (average 15 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start31 Jan 2017
- Primary completion1 May 2019
- Study completion16 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Young Adult, Cancer, Physical ActivityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Collaborators
- Froedtert Hospital, Children's Hospital and Health System Foundation, Wisconsin, Medical College of Wisconsin
- Responsible party
- Principal investigator, Jeanne M. Erickson, University of Wisconsin, Milwaukee
- Investigators
- Rachel Schiffman, PhD, Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000166
- Sponsor's protocol ID
- P20NR015339-PP3
- Other IDs
- P20NR015339
- Status last verified
- Jul 2021
- First submitted
- 15 Dec 2016
- Last updated
- 11 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step-Up Intervention for Self-Management of Fatigue in Young Adults Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT03000166
- Acronym / sponsor ID
- P20NR015339-PP3
- Conditions
- Young Adult, Cancer, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Collaborators
- Froedtert Hospital, Children's Hospital and Health System Foundation, Wisconsin, Medical College of Wisconsin
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Posted 11 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the impact of a physical activity intervention on the self-management of fatigue in young adults receiving chemotherapy. Half of the participants will receive an intervention which includes education and resources to set physical activity goals and monitor progress toward goals.
Detailed description
Interventions to increase physical activity have been shown to relieve fatigue in patients receiving chemotherapy, but no studies have tested a physical activity intervention to improve fatigue in young adults receiving chemotherapy. This study will determine the impact of a physical activity intervention on the self-management process variables of self-efficacy and self-regulation and their relationships to physical activity and fatigue severity in young adults receiving chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Step-Up Intervention Group | Experimental | Behavioral: Step-Up InterventionParticipants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity. |
| Attention Control Group | No intervention | –Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- have a diagnosis of cancer;
- are within the first two months of a chemotherapy regimen that will last at least another 3 months;
- are ambulatory without assistance;
- have written consent from their physician to participate;
- have the ability to understand English;
Key exclusion criteria (4 listed)
- symptoms of uncontrolled cardiopulmonary disease, neurological disease
- delayed wound healing
- high risk of bone fracture
- pre-existing peripheral neuropathy
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 |
|---|---|---|
| Step-Up InterventionIntervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker. | Behavioural | Step-Up Intervention Group |
Primary outcome
Self-efficacy for Physical Activity
Time frame: Completion of post-study measures (average 15 weeks)
Physical Activity Assessment Inventory (Haas \& Northam, 2010) The scale measures confidence to be physically active under various conditions. Scores range from 0=cannot do at all to 100=certain can do.
Self-regulation of Physical Activity
Time frame: Completion of post-study measures (average 15 weeks)
Index of Self-Regulation (Yeom et al., 2011) The scale measures self-regulation skills, including processing information, monitoring performance, and taking action to meet goals. Scores range from 1 to 6, with higher scores indicating agreement that the individual has these skills.
2 secondary outcomes
Steps Per Day
Time frame: Completion of post-study measures (average 15 weeks)
Fatigue Severity
Time frame: Completion of end-of-study measures (average 15 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Young Adult, Cancer, Physical Activity
Recruiting
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study
Pediatric Brain Tumor
Recruiting
Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm
RecruitingPhase 1/2
A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
Mature B-Cell Non-Hodgkin Lymphoma
Active, not recruiting
Optimization of a mHealth Physical Activity Promotion Intervention With Mindful Awareness for AYAO (OPT2MOVE)
Cancer
Active, not recruiting
Cancer Prevention for Young Rural Adults
Cancer
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.
Rachel Schiffman, PhD principal investigator
University of Wisconsin, Milwaukee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step-Up Intervention in people with Young Adult, Cancer, Physical Activity, run by University of Wisconsin, Milwaukee at 2 sites in United States.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 11 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-efficacy for Physical Activity (time frame: Completion of post-study measures (average 15 weeks)). The study lists 2 primary outcomes in all. 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 11 Aug 2021.