LymphomaLymfit_RCTNCT05257785
Lymfit to Improve the Fitness and Quality of Life in Lymphoma Survivors
A study testing Lymfit exercise intervention in people with Lymphoma and Cancer Survivors, run by McGill University at 1 site in Canada.
Trial summary
This randomized control trial seeks to determine whether a tailored and supervised exercise program adopting mobile-health technology will be able to improve fitness and quality of life among lymphoma survivors. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Lymphoma, Cancer Survivors
- What is being tested?
- Lymfit exercise intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2022to 1 Dec 2024
- 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 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- newly diagnosed lymphoma patients who received an initial diagnosis at the age of age 18-39,
- approved by their hematologist as having no contra-indications to vigorous exercise,
- receiving or has received chemotherapy with curative intent within the past 6 months,
- own a cellular phone that is able to download the Fitbit app and to complete the study questionnaires online in either French or English, and
- has an Internet connection at home that supports participation in coaching sessions via videoconferencing (zoom).
Who cannot join
- The patient has contra-indications to vigorous exercise,
- the patient doesn't want to wear a fitness tracker due to various concerns (as no Fitbit data could be collected).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3A 2A7
Christine Maheu, 5146165954, christine.maheu@mcgill.ca
About this study
Official title: Lymfit to Improve the Fitness and Quality of Life in Lymphoma Survivors: A Randomized Controlled Trial
This randomized control trial seeks to determine whether a tailored and supervised exercise program adopting mobile-health technology will be able to improve fitness and quality of life among lymphoma survivors.
Read the detailed description
Lymphoma is the most common cancer diagnosed in young adults. While curing 80% of patients, lymphoma treatment has a significant impact on young adults' health and psycho-social wellbeing by increasing fatigue and anxiety, risk of cardiovascular disease and other chronic disorders, all of which compromise one's quality of life. Regular exercise has the potential to reduce the side effects associated with cancer treatments. Thus, the most recent guidelines suggest that cancer patients should engage in adapted exercise programs during and after their treatment.
However, these guidelines are not systematically recommended by doctors and are often not followed by patients. Fatigue and lack of motivation are the main barriers to exercise among cancer survivors. Our study aims to identify young adults lymphoma patients and encourage them to adhere to the exercise guidelines with the help of an exercise physiologist and a fitness tracker. The investigators will evaluate the efficacy of these strategies in motivating exercise among young adults lymphoma survivors. Our proposed study carries significant implications for the prevention of complications of treatment for young adults lymphoma survivors.
- Conditions
- Lymphoma, Cancer Survivors
- Being tested
- Lymfit exercise intervention, Waitlist control
- Keywords
- Cancer survivorship, Quality of Life, Physical Activity, Fear of Recurrence, Randomized controlled trial
- Medical subject headings
- Lymphoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymfit exercise interventionBehavioural
Participants randomized to this arm will be allocated a pre-registered Inspire II / Charge IV model Fitbit. The kinesiologist of the study will meet with the participants for a baseline fitness assessment. The kinesiologist will examine the baseline physical activity levels, fitness level and sedentary behaviours of the participants, to design a personalized exercise prescription. Within one week after the baseline fitness assessment, the kinesiologist will contact the participants to discuss the exercise prescription. Every two weeks there-after, the kinesiologist will follow up with the participants via videoconferencing to discuss their progress and to modify or advance their exercise prescriptions as needed. Participants will be followed-up at 6 months and 12 months.
Waitlist controlBehavioural
Participants will be contacted by the study kinesiologist for a baseline fitness assessment 3 months after they consent, participants will be given a Fitbit, a personalized exercise prescription and receive bi-weekly follow-ups for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lymfit exercise intervention | Experimental | Participants randomized to the intervention group will be allocated a pre-registered Fitbit, a personalized exercise prescription designed by the kinesiologist, and 12 weeks of supervision by the kinesiologist. Receives: Behavioral: Lymfit exercise intervention |
| Waitlist control | Other | Participants will receive the exact same Lymfit exercise intervention 3 months after they consent to participate in the study. Receives: Behavioral: Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the exercise guideline as determined by comparing the active minutes captured in the Fitbit
The investigators will determine the percentage of lymphoma patients who adhere to the recommended exercise guidelines for cancer patients at baseline and after the intervention, i.e. compare the minutes of Moderate to vigorous physical activity per week captured in the Fitbit among participants in the intervention arm and waitlist control arm at baseline and 3 months.
Measured: 3 months
Secondary outcomes (3)
Change from baseline multi-dimensional Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System-29
The Patient-Reported Outcomes Measurement Information System-29 is a 29-item instrument assessing multi-dimensional eight domains (29 items) (i.e., anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, ability to participate in social roles and activities, and pain intensity). Raw scores generated for each domain are transformed into T scores; higher T scores indicate greater endorsement of the construct being assessed.
Measured: 12 months
Change from baseline Work Ability assessed by the Work Ability Index (WAI)
The Work Ability Index (WAI) questionnaire (7 items) will be used to collect productivity loss data within clinical trials and is suitable for direct translation into a monetary figure. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor [7-27], moderate [28-36], good (37-43) and excellent (44-49).
Measured: 12 months
Change from baseline Fear of Cancer Recurrence assessed by the Cancer Worry Scale (CWS)
Cancer Worry Scale is a six-item scale designed to measure worry about the risk of developing cancer and the impact of worry on daily functioning. The scale consists of six questions with four response options (1 = not at all or rarely; 2 = sometimes; 3 = often; 4 = almost all the time), such that each individual attains a score ranging from 6 (minimum worry) to 24 (maximum worry).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start15 Jan 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Jewish General Hospital, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Principal investigator, Christine Maheu, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257785
- Sponsor's protocol ID
- 2021-2560
- Acronym
- Lymfit_RCT
- Status last verified
- Apr 2024
- First submitted
- 9 Feb 2022
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymfit to Improve the Fitness and Quality of Life in Lymphoma Survivors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05257785
- Acronym / sponsor ID
- Lymfit_RCT / 2021-2560
- Conditions
- Lymphoma, Cancer Survivors
- Keywords
- Cancer survivorship, Quality of Life, Physical Activity, Fear of Recurrence, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Jewish General Hospital, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 25 Feb 2022 (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 randomized control trial seeks to determine whether a tailored and supervised exercise program adopting mobile-health technology will be able to improve fitness and quality of life among lymphoma survivors.
Detailed description
Lymphoma is the most common cancer diagnosed in young adults. While curing 80% of patients, lymphoma treatment has a significant impact on young adults' health and psycho-social wellbeing by increasing fatigue and anxiety, risk of cardiovascular disease and other chronic disorders, all of which compromise one's quality of life. Regular exercise has the potential to reduce the side effects associated with cancer treatments. Thus, the most recent guidelines suggest that cancer patients should engage in adapted exercise programs during and after their treatment.
However, these guidelines are not systematically recommended by doctors and are often not followed by patients. Fatigue and lack of motivation are the main barriers to exercise among cancer survivors. Our study aims to identify young adults lymphoma patients and encourage them to adhere to the exercise guidelines with the help of an exercise physiologist and a fitness tracker. The investigators will evaluate the efficacy of these strategies in motivating exercise among young adults lymphoma survivors. Our proposed study carries significant implications for the prevention of complications of treatment for young adults lymphoma survivors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymfit exercise intervention | Experimental | Behavioral: Lymfit exercise interventionParticipants randomized to the intervention group will be allocated a pre-registered Fitbit, a personalized exercise prescription designed by the kinesiologist, and 12 weeks of supervision by the kinesiologist. |
| Waitlist control | Other | Behavioral: Waitlist controlParticipants will receive the exact same Lymfit exercise intervention 3 months after they consent to participate in the study. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- newly diagnosed lymphoma patients who received an initial diagnosis at the age of age 18-39,
- approved by their hematologist as having no contra-indications to vigorous exercise,
- receiving or has received chemotherapy with curative intent within the past 6 months,
- own a cellular phone that is able to download the Fitbit app and to complete the study questionnaires online in either French or English, and
- has an Internet connection at home that supports participation in coaching sessions via videoconferencing (zoom).
Key exclusion criteria (2 listed)
- The patient has contra-indications to vigorous exercise,
- the patient doesn't want to wear a fitness tracker due to various concerns (as no Fitbit data could be collected).
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 |
|---|---|---|
| Lymfit exercise interventionParticipants randomized to this arm will be allocated a pre-registered Inspire II / Charge IV model Fitbit. The kinesiologist of the study will meet with the participants for a baseline fitness assessment. The kinesiologist will examine the baseline physical activity levels, fitness level and sedentary behaviours of the participants, to design a personalized exercise prescription. Within one week after the baseline fitness assessment, the kinesiologist will contact the participants to discuss the exercise prescription. Every two weeks there-after, the kinesiologist will follow up with the participants via videoconferencing to discuss their progress and to modify or advance their exercise prescriptions as needed. Participants will be followed-up at 6 months and 12 months. | Behavioural | Lymfit exercise intervention |
| Waitlist controlParticipants will be contacted by the study kinesiologist for a baseline fitness assessment 3 months after they consent, participants will be given a Fitbit, a personalized exercise prescription and receive bi-weekly follow-ups for 12 weeks. | Behavioural | Waitlist control |
Primary outcome
Change of the exercise guideline as determined by comparing the active minutes captured in the Fitbit
Time frame: 3 months
The investigators will determine the percentage of lymphoma patients who adhere to the recommended exercise guidelines for cancer patients at baseline and after the intervention, i.e. compare the minutes of Moderate to vigorous physical activity per week captured in the Fitbit among participants in the intervention arm and waitlist control arm at baseline and 3 months.
3 secondary outcomes
Change from baseline multi-dimensional Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System-29
Time frame: 12 months
Change from baseline Work Ability assessed by the Work Ability Index (WAI)
Time frame: 12 months
Change from baseline Fear of Cancer Recurrence assessed by the Cancer Worry Scale (CWS)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymfit exercise intervention in people with Lymphoma and Cancer Survivors, run by McGill University 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 5 inclusion and 2 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 5 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Maheu, Ph.D. (514-616-5954, christine.maheu@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the exercise guideline as determined by comparing the active minutes captured in the Fitbit (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.