A Diagnosis of Any Hematologic or Solid MalignancyNCT02627079
ICanSTEP : Increasing Physical Activity With Text Messaging
A study testing Daily SMS text messaging in people with A Diagnosis of Any Hematologic or Solid Malignancy, run by Duke University at 1 site in United States.
Trial summary
The proposed pilot study will develop and test feasibility and preliminary efficacy of an exercise motivation intervention using a 12-week smartphone-text messaging program tailored to physical activity data retrieved from a Fitbit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- A Diagnosis of Any Hematologic or Solid Malignancy
- What is being tested?
- Daily SMS text messaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2016to 21 May 2018
- 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
- Eligible participants must be / have
- age 18 or older,
- a diagnosis of any hematologic or solid malignancy
- a life expectancy of at least 12 months
- ECOG < /=2
- in active cancer treatment or have completed active cancer treatment within one year of obtaining consent (with the exception of adjuvant hormonal therapy),
Show all 12Show fewer
- not scheduled for any major surgery during the anticipated study period,
- able to read and understand English
- sedentary defined as participating in 2 or less days of dedicated physical activity per week,
- consistent daily access to a smartphone
- a text messaging plan that includes a minimum of 150 text messages a month at no additional cost
- capable of providing informed consent.
Who cannot join
- Significant cardiac disease (i.e., left ventricular ejection fraction of <50%, unstable angina, placement of cardiac stents and myocardial infarction within previous 6 months)
- Contraindications to a 6-minute walk test as recommended by the American Thoracic Society: (a) acute myocardial infarction (3-5 days), (b) unstable angina, (c) uncontrolled arrhythmias causing symptoms or hemodynamic compromise, (d) syncope, (e) acute endocarditis, (f) acute myocarditis or pericarditis, (g) uncontrolled heart failure, (h) acute pulmonary embolus or pulmonary infarction, (i) thrombosis of lower extremities, (j) suspected dissecting aneurysm, (k) uncontrolled asthma, (l) pulmonary edema, (m) room air desaturation at rest ≤85%, (n) respiratory failure, (o) acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise, (p) mental impairment leading to inability to cooperate, and (q) extensive bone metastases
- ECOG >2
- Participates in 3 or more days of dedicated physical activity per week
- Known allergic reaction to nickel
- No access to a smart phone or text messaging plan less than 150 messages per month
- Physical or psychological contraindication to participation at the discretion of the treating physician.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ICanSTEP: Increasing Physical Activity in Cancer Survivors Through a Text-messaging Exercise Motivation Program
The proposed pilot study will develop and test feasibility and preliminary efficacy of an exercise motivation intervention using a 12-week smartphone-text messaging program tailored to physical activity data retrieved from a Fitbit. Target population is 15 cancer survivors and 15 patients actively undergoing cancer treatment.
Read the detailed description
Cancer survivors have substantial residual cardiometabolic risk due to the fact that they are living longer and are exposed to the same lifestyle and environmental factors that have led to the drastic increase in obesity and diabetes in Western societies over the last four decades. In addition, survivors' cardiovascular health is significantly impaired due to cancer treatment. Research has shown that physical activity improves quality of life in cancer survivors, ameliorates treatment-related side effects reduces the risk of cancer recurrence, and extends overall survival. Despite these advantages, most cancer patients are sedentary. The early survivor period is a teachable moment to improve healthy behaviors. Social Cognitive Theory argues that to change exercise behavior, we must increase behavior change self-efficacy of participants (i.e., confidence), increase their outcome expectations that changing their behavior will lead to better health, enhance motivation to exercise, enhance their ability to regulate their behavior (self-regulation), teach them tangible behavior change skills, and help them overcome barriers to behavior change. In this study validated patient-reported outcomes will be performed at baseline and at 12 weeks - FACIT-F to document general cancer symptoms with additional questions on fatigue, the Beck Depression Inventory (BDI-II), and the modified Godin-Leisure Questionnaire as a measure of activity level. The investigators will also perform baseline and 3 month weight / BMI and 6-minute walk testing as a second well-validated objective measure of fitness. At enrollment and at 3 months, patients will be queried as to barriers to behavior change. At 3 months, patients will be asked by 5-point Likert scale how helpful the program was in increasing their physical activity. Six months after enrollment (+/- 4 weeks), level of physical activity and use of Fitbit will be determined.
- Being tested
- Daily SMS text messaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily SMS text messagingOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | Cohort 1 will include 15 sedentary participants who have completed all cancer therapy except adjuvant hormonal therapy.
All participants will be provided a Fitbit. Participants will then be provided daily SMS text messaging tailored to their activity level for 12 weeks.. Receives: Other: Daily SMS text messaging |
| Cohort 2 | Active comparator | Cohort 2 will include 15 sedentary participants in active treatment. All participants will be provided a Fitbit. Participants will then be provided daily SMS text messaging tailored to their activity levels for 12 weeks. Receives: Other: Daily SMS text messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, as measured by the percentage of eligible patients who can be enrolled
Measured: 6 months
Feasibility, as measured by accrual rate
Measured: 6 months
Change in daily step count, as measured by Fitbit
Measured: Baseline, 12 weeks
Change in minutes of weekly exercise, as measured by Fitbit
Measured: Baseline, 12 weeks
Change in fatigue, as measured by questionnaire
Measured: Baseline, 12 weeks
Change in depression, as measured by questionnaire
Measured: Baseline, 12 weeks
Change in general activity, as measured by questionnaire
Measured: Baseline, 6 months
Change in quality of life, as measured by questionnaire
Measured: Baseline, 12 weeks
Change in body mass index (BMI)
Measured: Baseline, 12 weeks
Secondary outcomes (7)
Mean difference in daily step count, as measured by Fitbit
This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.
Measured: Baseline, 12 weeks
Mean difference in minutes of weekly exercise, as measured by Fitbit
This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.
Measured: Baseline, 12 weeks
Mean difference in fatigue, as measured by questionnaire
This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.
Measured: Baseline, 12 weeks
Mean difference in depression, as measured by questionnaire
This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.
Measured: Baseline, 12 weeks
Mean difference in general activity, as measured by questionnaire
This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.
Measured: Baseline, 12 weeks
Mean difference in quality of life, as measured by questionnaire
This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.
Measured: Baseline, 12 weeks
Mean difference in body mass index (BMI)
This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start4 Aug 2016
- Primary completion6 Feb 2018
- Study completion21 May 2018
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 A Diagnosis of Any Hematologic or Solid MalignancyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bridget Koontz, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627079
- Sponsor's protocol ID
- Pro00068978
- Status last verified
- Jun 2021
- First submitted
- 8 Dec 2015
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Koontz BF, Levine E, McSherry F, Niedzwiecki D, Sutton L, Dale T, Streicher M, Rushing C, Owen L, Kraus WE, Bennett G, Pollak KI. Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP). Support Care Cancer. 2021 Dec;29(12):7339-7349. doi: 10.1007/s00520-021-06281-y. Epub 2021 May 28.
PubMed 34050402
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICanSTEP: Increasing Physical Activity in Cancer Survivors Through a Text-messaging Exercise Motivation Program
- ClinicalTrials.gov ID
- NCT02627079
- Acronym / sponsor ID
- Pro00068978
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 4 Aug 2016 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 21 May 2018 (actual)
- First posted
- 10 Dec 2015 (estimated)
- 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 proposed pilot study will develop and test feasibility and preliminary efficacy of an exercise motivation intervention using a 12-week smartphone-text messaging program tailored to physical activity data retrieved from a Fitbit. Target population is 15 cancer survivors and 15 patients actively undergoing cancer treatment.
Detailed description
Cancer survivors have substantial residual cardiometabolic risk due to the fact that they are living longer and are exposed to the same lifestyle and environmental factors that have led to the drastic increase in obesity and diabetes in Western societies over the last four decades. In addition, survivors' cardiovascular health is significantly impaired due to cancer treatment. Research has shown that physical activity improves quality of life in cancer survivors, ameliorates treatment-related side effects reduces the risk of cancer recurrence, and extends overall survival. Despite these advantages, most cancer patients are sedentary. The early survivor period is a teachable moment to improve healthy behaviors. Social Cognitive Theory argues that to change exercise behavior, we must increase behavior change self-efficacy of participants (i.e., confidence), increase their outcome expectations that changing their behavior will lead to better health, enhance motivation to exercise, enhance their ability to regulate their behavior (self-regulation), teach them tangible behavior change skills, and help them overcome barriers to behavior change. In this study validated patient-reported outcomes will be performed at baseline and at 12 weeks - FACIT-F to document general cancer symptoms with additional questions on fatigue, the Beck Depression Inventory (BDI-II), and the modified Godin-Leisure Questionnaire as a measure of activity level. The investigators will also perform baseline and 3 month weight / BMI and 6-minute walk testing as a second well-validated objective measure of fitness. At enrollment and at 3 months, patients will be queried as to barriers to behavior change. At 3 months, patients will be asked by 5-point Likert scale how helpful the program was in increasing their physical activity. Six months after enrollment (+/- 4 weeks), level of physical activity and use of Fitbit will be determined.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Other: Daily SMS text messagingCohort 1 will include 15 sedentary participants who have completed all cancer therapy except adjuvant hormonal therapy. All participants will be provided a Fitbit. Participants will then be provided daily SMS text messaging tailored to their activity level for 12 weeks.. |
| Cohort 2 | Active comparator | Other: Daily SMS text messagingCohort 2 will include 15 sedentary participants in active treatment. All participants will be provided a Fitbit. Participants will then be provided daily SMS text messaging tailored to their activity levels for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Eligible participants must be / have
- age 18 or older,
- a diagnosis of any hematologic or solid malignancy
- a life expectancy of at least 12 months
- ECOG < /=2
Key exclusion criteria (7 listed)
- Significant cardiac disease (i.e., left ventricular ejection fraction of <50%, unstable angina, placement of cardiac stents and myocardial infarction within previous 6 months)
- Contraindications to a 6-minute walk test as recommended by the American Thoracic Society: (a) acute myocardial infarction (3-5 days), (b) unstable angina, (c) uncontrolled arrhythmias causing symptoms or hemodynamic compromise, (d) syncope, (e) acute endocarditis, (f) acute myocarditis or pericarditis, (g) uncontrolled heart failure, (h) acute pulmonary embolus or pulmonary infarction, (i) thrombosis of lower extremities, (j) suspected dissecting aneurysm, (k) uncontrolled asthma, (l) pulmonary edema, (m) room air desaturation at rest ≤85%, (n) respiratory failure, (o) acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise, (p) mental impairment leading to inability to cooperate, and (q) extensive bone metastases
- ECOG >2
- Participates in 3 or more days of dedicated physical activity per week
- Known allergic reaction to nickel
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 |
|---|---|---|
| Daily SMS text messaging | Other | Cohort 1, Cohort 2 |
Primary outcome
Feasibility, as measured by the percentage of eligible patients who can be enrolled
Time frame: 6 months
Feasibility, as measured by accrual rate
Time frame: 6 months
Change in daily step count, as measured by Fitbit
Time frame: Baseline, 12 weeks
Change in minutes of weekly exercise, as measured by Fitbit
Time frame: Baseline, 12 weeks
Change in fatigue, as measured by questionnaire
Time frame: Baseline, 12 weeks
Change in depression, as measured by questionnaire
Time frame: Baseline, 12 weeks
Change in general activity, as measured by questionnaire
Time frame: Baseline, 6 months
Change in quality of life, as measured by questionnaire
Time frame: Baseline, 12 weeks
Change in body mass index (BMI)
Time frame: Baseline, 12 weeks
7 secondary outcomes
Mean difference in daily step count, as measured by Fitbit
Time frame: Baseline, 12 weeks
Mean difference in minutes of weekly exercise, as measured by Fitbit
Time frame: Baseline, 12 weeks
Mean difference in fatigue, as measured by questionnaire
Time frame: Baseline, 12 weeks
Mean difference in depression, as measured by questionnaire
Time frame: Baseline, 12 weeks
Mean difference in general activity, as measured by questionnaire
Time frame: Baseline, 12 weeks
Mean difference in quality of life, as measured by questionnaire
Time frame: Baseline, 12 weeks
Mean difference in body mass index (BMI)
Time frame: Baseline, 12 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 10 Jun 2021.
- Results publication: PubMed 34050402Koontz BF, Levine E, McSherry F, Niedzwiecki D, Sutton L, Dale T, Streicher M, Rushing C, Owen L, Kraus WE, Bennett G, Pollak KI. Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP). Support Care Cancer. 2021 Dec;29(12):7339-7349. doi: 10.1007/s00520-021-06281-y. Epub 2021 May 28.
- Individual participant dataSharing planned: No
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.
Bridget Koontz, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily SMS text messaging in people with A Diagnosis of Any Hematologic or Solid Malignancy, run by Duke 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 12 inclusion and 7 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 10 Jun 2021. 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?
Feasibility, as measured by the percentage of eligible patients who can be enrolled (time frame: 6 months). The study lists 9 primary outcomes in all. 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 NCT02627079, 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 10 Jun 2021.