CancerNCT03120819
Exercise Information for Women With Cancer
A study testing Oncologist Recommendation and Oncologist Recommendation + DVD in people with Cancer, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Fatigue is a troublesome symptom for breast cancer patients, which might be mitigated with exercise. Cancer patients often prefer their oncologist recommend an exercise program, yet a recommendation alone may not be enough to change behavior. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer
- What is being tested?
- Oncologist Recommendation and Oncologist Recommendation + DVD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2010to 1 Apr 2017
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of breast cancer
- Scheduled for a clinical appointment with a surgical, radiation or medical oncologist at Oregon Health \& Science University (OHSU)
- Capable of answering survey questions by phone
Who cannot join
- Not medically cleared to participate in low-intensity exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Determine the Effect of Supplementing an Oncologist's Recommendation to Exercise With Multimedia on Fatigue Levels in Breast Cancer Patients
Fatigue is a troublesome symptom for breast cancer patients, which might be mitigated with exercise. Cancer patients often prefer their oncologist recommend an exercise program, yet a recommendation alone may not be enough to change behavior. Our study will determine whether adding an exercise DVD to an oncologist's recommendation to exercise led to better outcomes than a recommendation alone.
Read the detailed description
Purpose: Controlled, intervention trials suggest that exercise may be a useful strategy to manage symptoms and side effects associated with cancer treatment. However, practical programs that facilitate exercise engagement among cancer patients are few and have been insufficiently studied. Medical providers may be best suited to deliver exercise information because of their frequent patient contact and the trust that patients place in their advice; however, unless sufficient resources are supplied in conjunction with verbal advice, patients may be less likely to successfully follow their physician's advice. The addition of an easy-to-follow, cancer specific exercise instructional video (DVD) to a provider's recommendation to exercise may provide patients with the motivation and ability to increase physical activity. We propose a feasibility study that will 1) determine acceptance and use of a provider-disseminated instructional home-exercise DVD among female cancer patients treated at OHSU and 2) determine if this cancer specific home-based DVD exercise program leads to greater decreases in fatigue, increases in exercise motivation and in physical activity compared to a standard exercise recommendation only among breast cancer patients treated at OHSU (N=100).
Methods: Medical providers who see female cancer patients during routine clinical visits will be approached to participate in the study. Willing providers will be enlisted to consent patients to receive a brief conversation (2-3 minutes) about the importance of exercise in their cancer care and then ask whether or not patients are willing to receive more information about the study from study staff. Providers will inform study staff about consenting participants who will then be randomized to one of two groups in the order that they enrolled. Study staff will then contact participants by phone to further explain the study and confirm eligibility then ask questions about their treatment, symptoms, and physical activity history. Based on their randomly assigned group, participants will receive either a control packet of standard exercise information based on guidelines from the American Cancer Society or standard exercise information plus a cancer specific home-based exercise DVD program. Fatigue, motivation for exercise, physical activity and use / acceptability of exercise information (+/- DVD) will be reassessed at 4 and 8 weeks following enrollment.
- Conditions
- Cancer
- Being tested
- Oncologist Recommendation, Oncologist Recommendation + DVD
- Keywords
- exercise, fatigue, physical activity
- Medical subject headings
- Neoplasms, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncologist RecommendationBehavioural
Patients in this arm receive a 2-3 minute verbal recommendation about exercise from their treating oncologist
Oncologist Recommendation + DVDBehavioural
Patients in this arm receive a 2-3 minute verbal recommendation about exercise from their treating oncologist and then be sent an instructional exercise DVD to follow at their home three times per week for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Oncologist Recommendation only | Active comparator | Medical providers in this study provide a standardized brief recommendation for exercise to a consenting patient during a clinical visit. Patients randomized to this arm receive a packet that contained a study information sheet and standard published exercise information materials. The standard materials consisted of publicly available exercise recommendations for cancer survivors from the American Cancer Society (ACS). The packet of exercise information intended to represent general information about exercise and cancer that would be readily available to patients through the internet, a medical clinic, or cancer support services. Receives: Behavioral: Oncologist Recommendation |
| Oncologist Recommendation + DVD | Experimental | Participants in this arm receive the same oncologist's recommendation and written materials as the comparator group and also received an instructional yoga DVD. Inclusion of the video is intended to provide patients with a tool for following the oncologist's exercise recommendation. The instructional video contains a brief introduction from a breast cancer survivor, who was also featured in the exercise portion of the DVD, and safety information about lymphedema from a lymphedema therapist. The exercise program is a 30-minute, low intensity, restorative yoga program to improve whole body flexibility and to be safe for participants who were in active treatment for cancer and/or who had metastatic disease. Women are encouraged to use the DVD at least 3 times per week. Receives: Behavioral: Oncologist Recommendation + DVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-Reported Fatigue
Fatigue will be measured with the Brief Profile of Mood States Fatigue subscale
Measured: baseline, 4 and 8 weeks
Secondary outcomes (3)
Change in self-efficacy for exercise
Self-efficacy for exercise will be measured using the Self-Efficacy Assessment scale modified for exercise
Measured: baseline, 4 and 8 weeks
Change in exercise readiness assessed by the Stage of Change for exercise
We will measure a person's readiness to engage in recommended levels of physical activity using the Stage of Change for behavior change modified for exercise
Measured: baseline, 4 and 8 weeks
Change in self-report physical activity measured with the International Physical Activity Questionnaire
We will measure changes in the reported time spent in physical activities per week
Measured: Baseline, 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start1 Aug 2010
- Primary completion31 Jul 2011
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Model description
- 2 x 3 repeated measures design with 2 groups and 3 time points
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerri Winters, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120819
- Sponsor's protocol ID
- IRB00005997
- Status last verified
- Apr 2017
- First submitted
- 12 Apr 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Winters-Stone KM, Moe EL, Perry CK, Medysky M, Pommier R, Vetto J, Naik A. Enhancing an oncologist's recommendation to exercise to manage fatigue levels in breast cancer patients: a randomized controlled trial. Support Care Cancer. 2018 Mar;26(3):905-912. doi: 10.1007/s00520-017-3909-z. Epub 2017 Sep 30.
PubMed 28965138
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Determine the Effect of Supplementing an Oncologist's Recommendation to Exercise With Multimedia on Fatigue Levels in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03120819
- Acronym / sponsor ID
- IRB00005997
- Conditions
- Cancer
- Keywords
- exercise, fatigue, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- 31 Jul 2011 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 19 Apr 2017 (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.
Fatigue is a troublesome symptom for breast cancer patients, which might be mitigated with exercise. Cancer patients often prefer their oncologist recommend an exercise program, yet a recommendation alone may not be enough to change behavior. Our study will determine whether adding an exercise DVD to an oncologist's recommendation to exercise led to better outcomes than a recommendation alone.
Detailed description
Purpose: Controlled, intervention trials suggest that exercise may be a useful strategy to manage symptoms and side effects associated with cancer treatment. However, practical programs that facilitate exercise engagement among cancer patients are few and have been insufficiently studied. Medical providers may be best suited to deliver exercise information because of their frequent patient contact and the trust that patients place in their advice; however, unless sufficient resources are supplied in conjunction with verbal advice, patients may be less likely to successfully follow their physician's advice. The addition of an easy-to-follow, cancer specific exercise instructional video (DVD) to a provider's recommendation to exercise may provide patients with the motivation and ability to increase physical activity. We propose a feasibility study that will 1) determine acceptance and use of a provider-disseminated instructional home-exercise DVD among female cancer patients treated at OHSU and 2) determine if this cancer specific home-based DVD exercise program leads to greater decreases in fatigue, increases in exercise motivation and in physical activity compared to a standard exercise recommendation only among breast cancer patients treated at OHSU (N=100).
Methods: Medical providers who see female cancer patients during routine clinical visits will be approached to participate in the study. Willing providers will be enlisted to consent patients to receive a brief conversation (2-3 minutes) about the importance of exercise in their cancer care and then ask whether or not patients are willing to receive more information about the study from study staff. Providers will inform study staff about consenting participants who will then be randomized to one of two groups in the order that they enrolled. Study staff will then contact participants by phone to further explain the study and confirm eligibility then ask questions about their treatment, symptoms, and physical activity history. Based on their randomly assigned group, participants will receive either a control packet of standard exercise information based on guidelines from the American Cancer Society or standard exercise information plus a cancer specific home-based exercise DVD program. Fatigue, motivation for exercise, physical activity and use / acceptability of exercise information (+/- DVD) will be reassessed at 4 and 8 weeks following enrollment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- 2 x 3 repeated measures design with 2 groups and 3 time points
| Arm | Type | Receives |
|---|---|---|
| Oncologist Recommendation only | Active comparator | Behavioral: Oncologist RecommendationMedical providers in this study provide a standardized brief recommendation for exercise to a consenting patient during a clinical visit. Patients randomized to this arm receive a packet that contained a study information sheet and standard published exercise information materials. The standard materials consisted of publicly available exercise recommendations for cancer survivors from the American Cancer Society (ACS). The packet of exercise information intended to represent general information about exercise and cancer that would be readily available to patients through the internet, a medical clinic, or cancer support services. |
| Oncologist Recommendation + DVD | Experimental | Behavioral: Oncologist Recommendation + DVDParticipants in this arm receive the same oncologist's recommendation and written materials as the comparator group and also received an instructional yoga DVD. Inclusion of the video is intended to provide patients with a tool for following the oncologist's exercise recommendation. The instructional video contains a brief introduction from a breast cancer survivor, who was also featured in the exercise portion of the DVD, and safety information about lymphedema from a lymphedema therapist. The exercise program is a 30-minute, low intensity, restorative yoga program to improve whole body flexibility and to be safe for participants who were in active treatment for cancer and/or who had metastatic disease. Women are encouraged to use the DVD at least 3 times per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of breast cancer
- Scheduled for a clinical appointment with a surgical, radiation or medical oncologist at Oregon Health \& Science University (OHSU)
- Capable of answering survey questions by phone
Key exclusion criteria (1 listed)
- Not medically cleared to participate in low-intensity exercise
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 |
|---|---|---|
| Oncologist RecommendationPatients in this arm receive a 2-3 minute verbal recommendation about exercise from their treating oncologist | Behavioural | Oncologist Recommendation only |
| Oncologist Recommendation + DVDPatients in this arm receive a 2-3 minute verbal recommendation about exercise from their treating oncologist and then be sent an instructional exercise DVD to follow at their home three times per week for eight weeks | Behavioural | Oncologist Recommendation + DVD |
Primary outcome
Change in Patient-Reported Fatigue
Time frame: baseline, 4 and 8 weeks
Fatigue will be measured with the Brief Profile of Mood States Fatigue subscale
3 secondary outcomes
Change in self-efficacy for exercise
Time frame: baseline, 4 and 8 weeks
Change in exercise readiness assessed by the Stage of Change for exercise
Time frame: baseline, 4 and 8 weeks
Change in self-report physical activity measured with the International Physical Activity Questionnaire
Time frame: Baseline, 4 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Derived from this study: PubMed 28965138Winters-Stone KM, Moe EL, Perry CK, Medysky M, Pommier R, Vetto J, Naik A. Enhancing an oncologist's recommendation to exercise to manage fatigue levels in breast cancer patients: a randomized controlled trial. Support Care Cancer. 2018 Mar;26(3):905-912. doi: 10.1007/s00520-017-3909-z. Epub 2017 Sep 30.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oncologist Recommendation and Oncologist Recommendation + DVD in people with Cancer, run by Oregon Health and Science University at 1 site 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 3 inclusion and 1 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 19 Apr 2017. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Patient-Reported Fatigue (time frame: baseline, 4 and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03120819, which also lists 1 linked publication.
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 19 Apr 2017.