LeukemiaNCT03052777
Using Telephone Counselling to Improve Exercise Participation in Hematologic Cancer Survivors
A study testing Telephone counselling in people with Leukemia and Lymphoma, run by University of Alberta at 1 site in Canada.
Trial summary
This study evaluates the impact of a 12-week theory-based exercise telephone counselling program (versus a self-directed exercise group) on closing the exercise intention-behavior gap in a sample of hematologic cancer survivors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Leukemia, Lymphoma, Lymphoma, Non-Hodgkin
- What is being tested?
- Telephone counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- 21 Feb 2017to 1 Aug 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria for this study will be survivors who have had a histologically confirmed hematologic cancer, and who are between 18-80 years of age, living in Alberta, can speak and comprehend English, and willing to participate in a 12-week exercise telephone counseling intervention.
Who cannot join
- Survivors reporting greater or equal to 150 minutes of moderate-to-vigorous exercise will be excluded because they will already be meeting the public health guidelines for exercise. Survivors planning to be away for more than 2 weeks during the intervention, or with major exercise contraindications will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Quality of Life in Hematologic Cancer Survivors by Closing the Exercise Intention-Behavior Gap: a Phase II Randomized Controlled Trial of a Theory-based, Telephone-delivered Exercise Counselling Intervention
This study evaluates the impact of a 12-week theory-based exercise telephone counselling program (versus a self-directed exercise group) on closing the exercise intention-behavior gap in a sample of hematologic cancer survivors.
Read the detailed description
Problem: Regular exercise participation improves quality of life and physical function for cancer survivors. Unfortunately, the most effective way of promoting exercise to cancer survivors has yet to be determined, and as a result, many survivors are inactive. Theory-based efforts have typically focused on promoting intentions to exercise, though we are now discovering that only about half of those who intend to exercise actually follow through on their intentions. This is known as the exercise intention-behavior gap. It also appears that survivors are more likely to follow-through on their intention to exercise when they report employing key behavioral and motivational strategies (i.e., creating detailed exercise plans, feeling capable and obligated to exercise, perceiving it to be beneficial and fun, and avoiding the temptation to participate in alternative activities) which may be promoted via telephone counselling.
Objective: To determine whether a theory-based telephone counselling intervention focused on closing the exercise intention-behavior gap is feasible and can improve exercise levels, motivation, quality of life, and fatigue in hematologic cancer survivors.
Methods: A two-armed randomized controlled trial will compare the efficacy of telephone counselling versus a control condition (self-directed with Canada's Physical Activity Guide). All participants will be asked to increase their exercise by at least 60 minutes per week. Hematologic cancer survivors who previously participated in an exercise survey study and indicated interest in participating in future exercise related research (N=407) will be contacted to participate in the current trial. Eligible participants will be randomized in a 1:1 ratio to either the telephone counseling group or a self-directed exercise group. Participants in the intervention arm will receive 12 weekly telephone counseling sessions aimed at helping survivors follow-through on their exercise intention. A sample of approximately N=66 hematologic cancer survivors will be recruited for this 12-week trial. Data will be collected via online surveys assessing changes in exercise levels, motivation, quality of life, and fatigue. Feasibility will be determined by eligibility percentage, recruitment percentage, adherence rate, assessment completion rate, adverse events, and ratings of program acceptability.
- Conditions
- Leukemia, Lymphoma, Lymphoma, Non-Hodgkin, Behavior, Health
- Being tested
- Telephone counselling
- Medical subject headings
- Leukemia, Lymphoma, Lymphoma, Non-Hodgkin, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone counsellingBehavioural
The intervention is a 12 week telephone counselling exercise program where participants will receive weekly telephone counselling that targets key theoretical behavior change constructs. Participants will also receive a copy of Canada's Physical Activity Guideline.
| Study group | Role | What they receive |
|---|---|---|
| Telephone Counselling | Experimental | Participants will be asked to increase their exercise by at least 60 minutes per week and will receive a copy of Canada's Physical Activity Guideline plus 12 weekly telephone counseling sessions aimed at helping survivors follow-through on their exercise intention. Receives: Behavioral: Telephone counselling |
| Control | No intervention | Participants will be asked to increase their exercise by at least 60 minutes per week and will be self-directed, only receiving a copy of Canada's Physical Activity Guideline as standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Exercise Levels
Exercise levels assessed using the Godin Leisure-Time Exercise Questionnaire
Measured: Baseline and within 7 days of completing the 12-week intervention
Secondary outcomes (3)
Change from baseline in Exercise Motivation
Exercise motivation assessed via validated questionnaires that align with the Multi-Process Action Control Framework
Measured: Baseline and within 7 days of completing the 12-week intervention
Change from baseline in Quality of life
Quality of life assessed using the Short Form-36 (SF-36) questionnaire
Measured: Baseline and within 7 days of completing the 12-week intervention
Change from baseline in Fatigue
Fatigue assessed using the Functional Assessment of Cancer Therapy: Fatigue (FACT-F) questionnaire
Measured: Baseline and within 7 days of completing the 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start21 Feb 2017
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerry Courneya, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052777
- Sponsor's protocol ID
- HREBA.CC-16-0775
- Status last verified
- Oct 2017
- First submitted
- 31 Jan 2017
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vallerand JR, Rhodes RE, Walker GJ, Courneya KS. Social Cognitive Effects and Mediators of a Pilot Telephone Counseling Intervention to Increase Aerobic Exercise in Hematologic Cancer Survivors. J Phys Act Health. 2019 Jan 1;16(1):43-51. doi: 10.1123/jpah.2018-0014. Epub 2018 Dec 2.
PubMed 30501541Vallerand JR, Rhodes RE, Walker GJ, Courneya KS. Feasibility and preliminary efficacy of an exercise telephone counseling intervention for hematologic cancer survivors: a phase II randomized controlled trial. J Cancer Surviv. 2018 Jun;12(3):357-370. doi: 10.1007/s11764-018-0675-y. Epub 2018 Feb 6.
PubMed 29411314
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Life in Hematologic Cancer Survivors by Closing the Exercise Intention-Behavior Gap: a Phase II Randomized Controlled Trial of a Theory-based, Telephone-delivered Exercise Counselling Intervention
- ClinicalTrials.gov ID
- NCT03052777
- Acronym / sponsor ID
- HREBA.CC-16-0775
- Conditions
- Leukemia, Lymphoma, Lymphoma, Non-Hodgkin, Behavior, Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 14 Feb 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.
This study evaluates the impact of a 12-week theory-based exercise telephone counselling program (versus a self-directed exercise group) on closing the exercise intention-behavior gap in a sample of hematologic cancer survivors.
Detailed description
Problem: Regular exercise participation improves quality of life and physical function for cancer survivors. Unfortunately, the most effective way of promoting exercise to cancer survivors has yet to be determined, and as a result, many survivors are inactive. Theory-based efforts have typically focused on promoting intentions to exercise, though we are now discovering that only about half of those who intend to exercise actually follow through on their intentions. This is known as the exercise intention-behavior gap. It also appears that survivors are more likely to follow-through on their intention to exercise when they report employing key behavioral and motivational strategies (i.e., creating detailed exercise plans, feeling capable and obligated to exercise, perceiving it to be beneficial and fun, and avoiding the temptation to participate in alternative activities) which may be promoted via telephone counselling.
Objective: To determine whether a theory-based telephone counselling intervention focused on closing the exercise intention-behavior gap is feasible and can improve exercise levels, motivation, quality of life, and fatigue in hematologic cancer survivors.
Methods: A two-armed randomized controlled trial will compare the efficacy of telephone counselling versus a control condition (self-directed with Canada's Physical Activity Guide). All participants will be asked to increase their exercise by at least 60 minutes per week. Hematologic cancer survivors who previously participated in an exercise survey study and indicated interest in participating in future exercise related research (N=407) will be contacted to participate in the current trial. Eligible participants will be randomized in a 1:1 ratio to either the telephone counseling group or a self-directed exercise group. Participants in the intervention arm will receive 12 weekly telephone counseling sessions aimed at helping survivors follow-through on their exercise intention. A sample of approximately N=66 hematologic cancer survivors will be recruited for this 12-week trial. Data will be collected via online surveys assessing changes in exercise levels, motivation, quality of life, and fatigue. Feasibility will be determined by eligibility percentage, recruitment percentage, adherence rate, assessment completion rate, adverse events, and ratings of program acceptability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Counselling | Experimental | Behavioral: Telephone counsellingParticipants will be asked to increase their exercise by at least 60 minutes per week and will receive a copy of Canada's Physical Activity Guideline plus 12 weekly telephone counseling sessions aimed at helping survivors follow-through on their exercise intention. |
| Control | No intervention | –Participants will be asked to increase their exercise by at least 60 minutes per week and will be self-directed, only receiving a copy of Canada's Physical Activity Guideline as standard of care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria for this study will be survivors who have had a histologically confirmed hematologic cancer, and who are between 18-80 years of age, living in Alberta, can speak and comprehend English, and willing to participate in a 12-week exercise telephone counseling intervention.
Key exclusion criteria (1 listed)
- Survivors reporting greater or equal to 150 minutes of moderate-to-vigorous exercise will be excluded because they will already be meeting the public health guidelines for exercise. Survivors planning to be away for more than 2 weeks during the intervention, or with major exercise contraindications will also be excluded.
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 |
|---|---|---|
| Telephone counsellingThe intervention is a 12 week telephone counselling exercise program where participants will receive weekly telephone counselling that targets key theoretical behavior change constructs. Participants will also receive a copy of Canada's Physical Activity Guideline. | Behavioural | Telephone Counselling |
Primary outcome
Change from baseline in Exercise Levels
Time frame: Baseline and within 7 days of completing the 12-week intervention
Exercise levels assessed using the Godin Leisure-Time Exercise Questionnaire
3 secondary outcomes
Change from baseline in Exercise Motivation
Time frame: Baseline and within 7 days of completing the 12-week intervention
Change from baseline in Quality of life
Time frame: Baseline and within 7 days of completing the 12-week intervention
Change from baseline in Fatigue
Time frame: Baseline and within 7 days of completing the 12-week intervention
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 3 Oct 2017.
- Derived from this study: PubMed 30501541Vallerand JR, Rhodes RE, Walker GJ, Courneya KS. Social Cognitive Effects and Mediators of a Pilot Telephone Counseling Intervention to Increase Aerobic Exercise in Hematologic Cancer Survivors. J Phys Act Health. 2019 Jan 1;16(1):43-51. doi: 10.1123/jpah.2018-0014. Epub 2018 Dec 2.
- Derived from this study: PubMed 29411314Vallerand JR, Rhodes RE, Walker GJ, Courneya KS. Feasibility and preliminary efficacy of an exercise telephone counseling intervention for hematologic cancer survivors: a phase II randomized controlled trial. J Cancer Surviv. 2018 Jun;12(3):357-370. doi: 10.1007/s11764-018-0675-y. Epub 2018 Feb 6.
- 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 Telephone counselling in people with Leukemia and Lymphoma, run by University of Alberta at 1 site in Canada.
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 1 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 3 Oct 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 Canada. 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 from baseline in Exercise Levels (time frame: Baseline and within 7 days of completing the 12-week intervention). 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 NCT03052777, which also lists 2 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 3 Oct 2017.