Quality of LifeQI_LFNCT05546489
Proof-of-concept Lymfif
A study testing Lymfit intervention in people with Quality of Life, run by McGill University at 1 site in Canada.
Trial summary
This proof-of-concept study was to explore the implementation feasibility to deliver the Lymfit intervention to participants remotely during the pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- Lymfit intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2021to 1 Feb 2022
- 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
- 1. previously diagnosed with lymphoma
- 2. have completed chemotherapy
- 3. had access to a smart phone or an electronic device (e.g., tablet) that allowed them to attend virtual meetings and install the Fitbit application
Who cannot join
- -1. have any contra-indications to performing physical activities as determined by the hematologist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof-of-concept Study of Lymfit: A Personalized, Virtual Exercise Intervention to Improve Health Outcomes in Lymphoma Survivors in the Pandemic
This proof-of-concept study was to explore the implementation feasibility to deliver the Lymfit intervention to participants remotely during the pandemic.
- Conditions
- Quality of Life
- Being tested
- Lymfit intervention
- Keywords
- Quality of Life, cancer survivors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymfit interventionBehavioural
Wearable activity trackers (Fitbit) were given to participants as a motivational tool and for data collection purposes. Participants received a personalized exercise prescription designed by a kinesiologist. Physiologic metrics were collected by the Fitbit monitors and were stored in the Lymfit database. Self-reported questionnaires measuring health outcomes were collected at baseline and post-intervention.
| Study group | Role | What they receive |
|---|---|---|
| Lymfit intervention | Experimental | Participants will receive a Fitbit wearable tracker, expert guidance, and a personalized exercise prescription to optimize physical activities among lymphoma survivors. The intervention is 12 weeks long, participants are meeting with a kinesiologist every 2 weeks. Receives: Behavioral: Lymfit intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life : changes from baseline to post-intervention
Patient-Reported Outcomes Measurement Information System 29 items The scale has 29 items which measure perceived health status along 7 domains (physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference), with items answered on five-point Likert scales. Raw scores generated for each domain will be transformed into a T score. The T score range from -0.022 to 1.0, with higher scores indicating greater endorsement of the construct being assessed.
Measured: 12 weeks
Secondary outcomes (2)
Fear of Cancer Recurrence : changes from baseline to post-intervention
Fear of Cancer Recurrence Inventory 42 items
Measured: 12 weeks
Fear related to the pandemic : changes from baseline to post-intervention
the Fear of 2019 coronavirus disease (COVID) scale 7 items The items are rated on a five-point Likert scale ranging from "strongly disagree" (1) to "strongly agree" (5) with total scores ranging from 7 to 35. Higher total scores represent higher levels of fear.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 May 2021
- Primary completion1 Nov 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Maheu, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546489
- Sponsor's protocol ID
- QI_LF
- Acronym
- QI_LF
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-concept Study of Lymfit: A Personalized, Virtual Exercise Intervention to Improve Health Outcomes in Lymphoma Survivors in the Pandemic
- ClinicalTrials.gov ID
- NCT05546489
- Acronym / sponsor ID
- QI_LF / QI_LF
- Conditions
- Quality of Life
- Keywords
- Quality of Life, cancer survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 19 Sep 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 proof-of-concept study was to explore the implementation feasibility to deliver the Lymfit intervention to participants remotely during the pandemic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymfit intervention | Experimental | Behavioral: Lymfit interventionParticipants will receive a Fitbit wearable tracker, expert guidance, and a personalized exercise prescription to optimize physical activities among lymphoma survivors. The intervention is 12 weeks long, participants are meeting with a kinesiologist every 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. previously diagnosed with lymphoma
- 2. have completed chemotherapy
- 3. had access to a smart phone or an electronic device (e.g., tablet) that allowed them to attend virtual meetings and install the Fitbit application
Key exclusion criteria (1 listed)
- -1. have any contra-indications to performing physical activities as determined by the hematologist
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 interventionWearable activity trackers (Fitbit) were given to participants as a motivational tool and for data collection purposes. Participants received a personalized exercise prescription designed by a kinesiologist. Physiologic metrics were collected by the Fitbit monitors and were stored in the Lymfit database. Self-reported questionnaires measuring health outcomes were collected at baseline and post-intervention. | Behavioural | Lymfit intervention |
Primary outcome
Quality of Life : changes from baseline to post-intervention
Time frame: 12 weeks
Patient-Reported Outcomes Measurement Information System 29 items The scale has 29 items which measure perceived health status along 7 domains (physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference), with items answered on five-point Likert scales. Raw scores generated for each domain will be transformed into a T score. The T score range from -0.022 to 1.0, with higher scores indicating greater endorsement of the construct being assessed.
2 secondary outcomes
Fear of Cancer Recurrence : changes from baseline to post-intervention
Time frame: 12 weeks
Fear related to the pandemic : changes from baseline to post-intervention
Time frame: 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 21 Sep 2022.
- 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 Lymfit intervention in people with Quality of Life, 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 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 21 Sep 2022. 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?
Quality of Life : changes from baseline to post-intervention (time frame: 12 weeks). 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 21 Sep 2022.