Cancer, BreastIMPETUSNCT03036436
The IMPETUS Cancer Trial. A Technology Delivered Physical Activity Intervention in Cancer
A study testing Intervention in people with Cancer, Breast and Cancer, Colorectal, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial summary
Participants will take part in a 12 week intervention, with at least one follow up at 24 +/- 2 weeks. Each participant will be provided with support, motivation and professional guidance about improving physical activity (PA) levels and will be given a commercially available PA tracker. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Breast, Cancer, Colorectal, Malignancy
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2017to Dec 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
- Agreement of the participant's cancer clinician that he/she can participate, including medical clearance to exercise
- Aged >18 years
- Completed chemotherapy or radiotherapy with curative intent within the preceding 3 years. Patients may have had chemotherapy or radiotherapy as the sole treatment for cancer, but not surgery alone. Patients who are still on adjuvant hormone therapy and/or adjuvant Her2-directed therapy are eligible (with physician agreement as above).
- Able to understand English
- Owns or has access to a device which is compatible with the Fitbit app i.e. smartphone, tablet or computer.
Who cannot join
- Diagnosis of prostate cancer or upper gastro-intestinal cancer.
- Chronic medical and orthopaedic conditions that would preclude exercise (e.g uncontrolled congestive heart failure or angina, recent MI within 6 months recent Pulmonary embolism within 3 months, breathing difficulties requiring oxygen use or hospitalization, osteoarthritis causing significant mobility issues).
- Confirmed pregnancy
- Dementia, cognitive impairment or psychiatric illness that would preclude ability to participate in study.
- Incomplete haematological recovery after chemotherapy (WCC < 3, Hb < 10 or Platelets < 100).
- Patients<18 years
- Evidence of active cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Feasibility and Acceptability of a Technology Delivered Physical Activity (PA) Intervention in Cancer: The IMPETUS Cancer Trial. (IMproving Physical Activity and Exercise With Technology Use in Cancer Survivors)
Participants will take part in a 12 week intervention, with at least one follow up at 24 +/- 2 weeks. Each participant will be provided with support, motivation and professional guidance about improving physical activity (PA) levels and will be given a commercially available PA tracker. The PA tracker will also include a smartphone or web-based application, where participants can upload their exercise performed each day, and keep up to date with their goals using their smartphone or by logging on to their computer. The aim of the study is to find out how useful and effective technology with support from a healthcare professional is in helping cancer survivors to become more physically active.
This study will measure objective PA levels of the participants at the start of the study and at the end. The acceptability of using this intervention to promote PA in cancer survivors will also be investigated.
Read the detailed description
The overall aim is to determine the feasibility of a specific PA intervention, combining technology and professional input, in the cancer survivor population.
Study Design: A single arm feasibility trial of a PA intervention using technology and behavioural change theories as tools to achieve increased PA. Participants in the study will receive 12 weeks of the intervention. Outcomes will be measured at baseline, 12 weeks and 24 weeks (+/- 2 weeks) post baseline.
Patient recruitment: Participants will be recruited from those attending the St. James' Hospital oncology and haematology services. Study personnel will provide further information to these patients and assess them for eligibility. Informed consent will be gained from each participant.
Sample size: Proposed sample size is 60 (based on Sim and Lewis, 2012 recommendations) and allowing for 20% drop-out.
Intervention: This study will use the commercially available 'Fitbit' wearable technology with its paired smartphone application. PA goals will be prescribed by a qualified, chartered physiotherapist using the American Cancer Society (ACS) guidelines (Doyle et al 2006). Participants will use the Fitbit and its paired application for 12 weeks. The Fitbit device is a tool for motivation and monitoring of PA behaviours in this intervention.
This study will also use evidence-based psychological behavioural change theory. Behavioural change techniques include 'self-monitoring of behaviour', 'goal-setting', 'feedback on behaviour' and 'information about health consequences'.
Procedures: This study includes time-points at baseline, 12 weeks (Intervention end) and 24 weeks post baseline (+/- 2 weeks (Follow-up).
Pre-intervention:Consent and PA measurement
- Consent: Study personnel meets potential participants at their outpatient appointment. The agreement of the patient's consultant to exercise has been obtained before the patient information leaflet (PIL) is provided. The researcher explains the study and gives the potential participant a consent form and a patient information leaflet and a verbal explanation of the study.
- Initial PA measurement: Participants who consent are given an Actigraph PA monitor which they will be instructed to wear for 7 days to measure their baseline physical activity levels. Participants who wish to consider the study can take the PIL home, post it back, and receive the Actigraph by post.
Baseline Session:
Participants attend
- 1) An educational session, delivered by the lead researcher, a chartered physiotherapist. This is a group information session on PA following cancer treatment.
- 2) Educational session to introduce the technological component to the participants and instruct them in use and upload of Fitbit data to allow monitoring by researcher(s).
- 3) Measurement of height, weight, BMI and body composition and 6 minute walk test During intervention. (week 1-12)
- Participants wear Fitbit and upload data for self-monitoring and monitoring by chartered physiotherapist researcher.
- Participants receive scheduled structured telephone calls, giving them feedback on their achievement of goals and reminders about uploading data as follows; 2 calls each week till week 4, 1 call a week between week 4 and 8 and 2 calls, 2 weeks apart between week 8 and week 12.
After intervention ends (12 weeks):
- Measurement of height, weight, BMI and body composition and 6 minute walk test
- Participants wear Actigraph x 7 days 12 weeks after end of intervention:
- Measurement of height, weight, BMI and body composition and 6 minute walk test
- Participants wear Actigraph x 7 days
- Conditions
- Cancer, Breast, Cancer, Colorectal, Malignancy
- Being tested
- Intervention
- Keywords
- Cancer, EHealth, Cancer Survivor, Rehabilitation
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
A physical activity intervention, delivered remotely using a combination of the Fitbit application and support from a chartered physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in this group will receive the intervention. They will receive a Fitbit activity tracker, and will also receive support and goal setting with a view to improving their daily physical activity. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity (Objective)
Accelerometry will be used to monitor 7 days of activity at Week 0, Week 12 (+/- 2 weeks) and 24 weeks (+/- 2 weeks) post baseline.
Measured: Baseline, 12 weeks, 24 weeks
Evaluation of recruitment capability and resulting sample characteristics
The number of participants we can recruit will be assessed. This will explore the potential sample size of the randomised control trial.
Measured: 12 weeks
Data collection procedures and outcome measures
Procedures to collect data will be assessed for suitability and outcome measures used will be analysed for optimisation of measurement of clinical outcomes
Measured: 12 weeks
Acceptability and suitability of the intervention and study procedures
Compliance with daily logging of exercise information and adherence to the intervention duration will be assessed
Measured: 12 weeks
Use of resources and ability to manage and implement the study and intervention
The ability of study personnel and the availability of resources to implement the study will be assessed, demonstrated by successful implementation of the intervention
Measured: 12 weeks
Preliminary evaluation of participant responses to intervention
The qualitative outcome in this feasibility study will invite participants' to provide feedback on the intervention's likelihood of being successful. Satisfaction with the technological intervention will be measured using a questionnaire given to participants at study end (12 weeks).
Measured: 12 weeks
Change in body composition
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in percentage body fat.
Measured: Baseline, 12 weeks and 24 weeks
Change in self-report PA
A modified version of the Godin Leisure Time Exercise Questionnaire will be used.
Measured: Baseline, 12 weeks and 24 weeks
Change in quality of life
The FACT-G scale (general) (Cella et al 1993) will be used to assess quality of life.
Measured: Baseline, 12 weeks and 24 weeks
Change in aerobic capacity/endurance
This will be measured using the 6MWT (Six minute walk test).
Measured: Baseline,12 weeks and 24 weeks
Change in BMI
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in kg/m^2.
Measured: Baseline, 12 weeks and 24 weeks
Change in Body Weight (kg)
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in kg.
Measured: Baseline,12 weeks and 24 weeks
Change in waist circumference
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in cm.
Measured: Baseline,12 weeks and 24 weeks
Change in quality of life
The physical functional measure of the SF-36 (Brazier et al 1992) will be used to measure quality of life.
Measured: Baseline,12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cancer, BreastStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciaran Haberlin, University of Dublin, Trinity College
- Investigators
- Ciaran Haberlin, BSc(Physiotherapy), Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036436
- Sponsor's protocol ID
- IMPETUS-01
- Acronym
- IMPETUS
- Status last verified
- Jul 2018
- First submitted
- 19 Dec 2016
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.
PubMed 22169081Doyle C, Kushi LH, Byers T, Courneya KS, Demark-Wahnefried W, Grant B, McTiernan A, Rock CL, Thompson C, Gansler T, Andrews KS; 2006 Nutrition, Physical Activity and Cancer Survivorship Advisory Committee; American Cancer Society. Nutrition and physical activity during and after cancer treatment: an American Cancer Society guide for informed choices. CA Cancer J Clin. 2006 Nov-Dec;56(6):323-53. doi: 10.3322/canjclin.56.6.323.
PubMed 17135691Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983 Jun;51(3):390-5. doi: 10.1037//0022-006x.51.3.390. No abstract available.
PubMed 6863699Bandura, A. (1986). Social foundations of thought and action: A social cognitive theory. Englewood Cliffs, NJ, US, Prentice-Hall, Inc.
Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.
PubMed 23512568Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
PubMed 4053261Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
PubMed 8445433Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.
PubMed 1285753BALKE B. A SIMPLE FIELD TEST FOR THE ASSESSMENT OF PHYSICAL FITNESS. REP 63-6. Rep Civ Aeromed Res Inst US. 1963 Apr:1-8. No abstract available.
PubMed 14131272Haberlin C, Broderick J, Guinan EM, Darker C, Hussey J, O'Donnell DM. eHealth-based intervention to increase physical activity levels in people with cancer: protocol of a feasibility trial in an Irish acute hospital setting. BMJ Open. 2019 Mar 8;9(3):e024999. doi: 10.1136/bmjopen-2018-024999.
PubMed 30852540
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Feasibility and Acceptability of a Technology Delivered Physical Activity (PA) Intervention in Cancer: The IMPETUS Cancer Trial. (IMproving Physical Activity and Exercise With Technology Use in Cancer Survivors)
- ClinicalTrials.gov ID
- NCT03036436
- Acronym / sponsor ID
- IMPETUS / IMPETUS-01
- Conditions
- Cancer, Breast, Cancer, Colorectal, Malignancy
- Keywords
- Cancer, EHealth, Cancer Survivor, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 30 Jan 2017 (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.
Participants will take part in a 12 week intervention, with at least one follow up at 24 +/- 2 weeks. Each participant will be provided with support, motivation and professional guidance about improving physical activity (PA) levels and will be given a commercially available PA tracker. The PA tracker will also include a smartphone or web-based application, where participants can upload their exercise performed each day, and keep up to date with their goals using their smartphone or by logging on to their computer. The aim of the study is to find out how useful and effective technology with support from a healthcare professional is in helping cancer survivors to become more physically active.
This study will measure objective PA levels of the participants at the start of the study and at the end. The acceptability of using this intervention to promote PA in cancer survivors will also be investigated.
Detailed description
The overall aim is to determine the feasibility of a specific PA intervention, combining technology and professional input, in the cancer survivor population.
Study Design: A single arm feasibility trial of a PA intervention using technology and behavioural change theories as tools to achieve increased PA. Participants in the study will receive 12 weeks of the intervention. Outcomes will be measured at baseline, 12 weeks and 24 weeks (+/- 2 weeks) post baseline.
Patient recruitment: Participants will be recruited from those attending the St. James' Hospital oncology and haematology services. Study personnel will provide further information to these patients and assess them for eligibility. Informed consent will be gained from each participant.
Sample size: Proposed sample size is 60 (based on Sim and Lewis, 2012 recommendations) and allowing for 20% drop-out.
Intervention: This study will use the commercially available 'Fitbit' wearable technology with its paired smartphone application. PA goals will be prescribed by a qualified, chartered physiotherapist using the American Cancer Society (ACS) guidelines (Doyle et al 2006). Participants will use the Fitbit and its paired application for 12 weeks. The Fitbit device is a tool for motivation and monitoring of PA behaviours in this intervention.
This study will also use evidence-based psychological behavioural change theory. Behavioural change techniques include 'self-monitoring of behaviour', 'goal-setting', 'feedback on behaviour' and 'information about health consequences'.
Procedures: This study includes time-points at baseline, 12 weeks (Intervention end) and 24 weeks post baseline (+/- 2 weeks (Follow-up).
Pre-intervention:Consent and PA measurement
- Consent: Study personnel meets potential participants at their outpatient appointment. The agreement of the patient's consultant to exercise has been obtained before the patient information leaflet (PIL) is provided. The researcher explains the study and gives the potential participant a consent form and a patient information leaflet and a verbal explanation of the study.
- Initial PA measurement: Participants who consent are given an Actigraph PA monitor which they will be instructed to wear for 7 days to measure their baseline physical activity levels. Participants who wish to consider the study can take the PIL home, post it back, and receive the Actigraph by post.
Baseline Session:
Participants attend
- 1) An educational session, delivered by the lead researcher, a chartered physiotherapist. This is a group information session on PA following cancer treatment.
- 2) Educational session to introduce the technological component to the participants and instruct them in use and upload of Fitbit data to allow monitoring by researcher(s).
- 3) Measurement of height, weight, BMI and body composition and 6 minute walk test During intervention. (week 1-12)
- Participants wear Fitbit and upload data for self-monitoring and monitoring by chartered physiotherapist researcher.
- Participants receive scheduled structured telephone calls, giving them feedback on their achievement of goals and reminders about uploading data as follows; 2 calls each week till week 4, 1 call a week between week 4 and 8 and 2 calls, 2 weeks apart between week 8 and week 12.
After intervention ends (12 weeks):
- Measurement of height, weight, BMI and body composition and 6 minute walk test
- Participants wear Actigraph x 7 days 12 weeks after end of intervention:
- Measurement of height, weight, BMI and body composition and 6 minute walk test
- Participants wear Actigraph x 7 days
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionParticipants in this group will receive the intervention. They will receive a Fitbit activity tracker, and will also receive support and goal setting with a view to improving their daily physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Agreement of the participant's cancer clinician that he/she can participate, including medical clearance to exercise
- Aged >18 years
- Completed chemotherapy or radiotherapy with curative intent within the preceding 3 years. Patients may have had chemotherapy or radiotherapy as the sole treatment for cancer, but not surgery alone. Patients who are still on adjuvant hormone therapy and/or adjuvant Her2-directed therapy are eligible (with physician agreement as above).
- Able to understand English
- Owns or has access to a device which is compatible with the Fitbit app i.e. smartphone, tablet or computer.
Key exclusion criteria (7 listed)
- Diagnosis of prostate cancer or upper gastro-intestinal cancer.
- Chronic medical and orthopaedic conditions that would preclude exercise (e.g uncontrolled congestive heart failure or angina, recent MI within 6 months recent Pulmonary embolism within 3 months, breathing difficulties requiring oxygen use or hospitalization, osteoarthritis causing significant mobility issues).
- Confirmed pregnancy
- Dementia, cognitive impairment or psychiatric illness that would preclude ability to participate in study.
- Incomplete haematological recovery after chemotherapy (WCC < 3, Hb < 10 or Platelets < 100).
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 |
|---|---|---|
| InterventionA physical activity intervention, delivered remotely using a combination of the Fitbit application and support from a chartered physiotherapist. | Behavioural | Intervention |
Primary outcome
Change in Physical Activity (Objective)
Time frame: Baseline, 12 weeks, 24 weeks
Accelerometry will be used to monitor 7 days of activity at Week 0, Week 12 (+/- 2 weeks) and 24 weeks (+/- 2 weeks) post baseline.
Evaluation of recruitment capability and resulting sample characteristics
Time frame: 12 weeks
The number of participants we can recruit will be assessed. This will explore the potential sample size of the randomised control trial.
Data collection procedures and outcome measures
Time frame: 12 weeks
Procedures to collect data will be assessed for suitability and outcome measures used will be analysed for optimisation of measurement of clinical outcomes
Acceptability and suitability of the intervention and study procedures
Time frame: 12 weeks
Compliance with daily logging of exercise information and adherence to the intervention duration will be assessed
Use of resources and ability to manage and implement the study and intervention
Time frame: 12 weeks
The ability of study personnel and the availability of resources to implement the study will be assessed, demonstrated by successful implementation of the intervention
Preliminary evaluation of participant responses to intervention
Time frame: 12 weeks
The qualitative outcome in this feasibility study will invite participants' to provide feedback on the intervention's likelihood of being successful. Satisfaction with the technological intervention will be measured using a questionnaire given to participants at study end (12 weeks).
Change in body composition
Time frame: Baseline, 12 weeks and 24 weeks
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in percentage body fat.
Change in self-report PA
Time frame: Baseline, 12 weeks and 24 weeks
A modified version of the Godin Leisure Time Exercise Questionnaire will be used.
Change in quality of life
Time frame: Baseline, 12 weeks and 24 weeks
The FACT-G scale (general) (Cella et al 1993) will be used to assess quality of life.
Change in aerobic capacity/endurance
Time frame: Baseline,12 weeks and 24 weeks
This will be measured using the 6MWT (Six minute walk test).
Change in BMI
Time frame: Baseline, 12 weeks and 24 weeks
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in kg/m^2.
Change in Body Weight (kg)
Time frame: Baseline,12 weeks and 24 weeks
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in kg.
Change in waist circumference
Time frame: Baseline,12 weeks and 24 weeks
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in cm.
Change in quality of life
Time frame: Baseline,12 weeks and 24 weeks
The physical functional measure of the SF-36 (Brazier et al 1992) will be used to measure quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Background: PubMed 22169081Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.
- Background: PubMed 17135691Doyle C, Kushi LH, Byers T, Courneya KS, Demark-Wahnefried W, Grant B, McTiernan A, Rock CL, Thompson C, Gansler T, Andrews KS; 2006 Nutrition, Physical Activity and Cancer Survivorship Advisory Committee; American Cancer Society. Nutrition and physical activity during and after cancer treatment: an American Cancer Society guide for informed choices. CA Cancer J Clin. 2006 Nov-Dec;56(6):323-53. doi: 10.3322/canjclin.56.6.323.
- Background: PubMed 6863699Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983 Jun;51(3):390-5. doi: 10.1037//0022-006x.51.3.390. No abstract available.
- BackgroundBandura, A. (1986). Social foundations of thought and action: A social cognitive theory. Englewood Cliffs, NJ, US, Prentice-Hall, Inc.
- Background: PubMed 23512568Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.
- Background: PubMed 4053261Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
- Background: PubMed 8445433Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
- Background: PubMed 1285753Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.
- Background: PubMed 14131272BALKE B. A SIMPLE FIELD TEST FOR THE ASSESSMENT OF PHYSICAL FITNESS. REP 63-6. Rep Civ Aeromed Res Inst US. 1963 Apr:1-8. No abstract available.
- Derived from this study: PubMed 30852540Haberlin C, Broderick J, Guinan EM, Darker C, Hussey J, O'Donnell DM. eHealth-based intervention to increase physical activity levels in people with cancer: protocol of a feasibility trial in an Irish acute hospital setting. BMJ Open. 2019 Mar 8;9(3):e024999. doi: 10.1136/bmjopen-2018-024999.
- Individual participant dataSharing planned: Undecided
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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.
Ciaran Haberlin, BSc(Physiotherapy) principal investigator
University of Dublin, Trinity College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Cancer, Breast and Cancer, Colorectal, run by University of Dublin, Trinity College at 1 site in Ireland.
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 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: status not confirmed, as of the sponsor's last update on 24 Jul 2018. 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 Ireland. 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?
Change in Physical Activity (Objective) (time frame: Baseline, 12 weeks, 24 weeks). The study lists 14 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 NCT03036436, which also lists 10 linked publications.
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 24 Jul 2018.