Cancer SurvivorsLymfitNCT05259657
Feasibility, Acceptability, and Preliminary Effects of Lymfit
A study testing Lymfit Intervention in people with Cancer Survivors and Lymphoma, run by McGill University at 1 site in Canada.
Trial summary
Background: Lymphoma is one of the most diagnosed cancers in young adults aged 18 to 39. Lymphoma is highly treatable, and the survival rate is often high. Yet, cancer treatments can be toxic, and their side effects can negatively impact the quality of life among cancer survivors. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cancer Survivors, Lymphoma
- What is being tested?
- Lymfit 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
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2022to 1 Dec 2023
- 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 18 to 39
- Receiving or have received chemotherapy with curative intent within the past six months
- Own a smartphone that is able to download the Fitbit application
- Have an internet connection at home that supports participation in coaching sessions via videoconferencing and the ability to complete the study questionnaires online
- Proficient in either French or English
Who cannot join
- 1) Have any contra-indications to moderate to vigorous levels of exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Acceptability, and Preliminary Effects of a Physical Activity Intervention on Psychological Need Satisfaction, Exercise Motivation, Physical Activity Level, and Quality of Life: A Pilot Randomized Controlled Trial Among Young Adult Lymphoma Survivors
Background: Lymphoma is one of the most diagnosed cancers in young adults aged 18 to 39. Lymphoma is highly treatable, and the survival rate is often high. Yet, cancer treatments can be toxic, and their side effects can negatively impact the quality of life among cancer survivors. The current research suggests that being active after treatment can improve cancer outcomes. For instance, reducing cancer-related fatigue, anxiety, depression, and improving sleep quality and survival. Physical activities can greatly improve the quality of life after cancer treatment.
Knowledge Gap: Young adults are unique from cancer patients of other age groups. Young adults need stage-of-life-specific, person-centred cancer and survivorship care. Despite knowing that exercise is beneficial in improving cancer outcomes, cancer survivors' engagement and adherence to exercise guidelines remain poor. It is crucial to develop an effective intervention that can motivate lymphoma patients to be active after treatment.
Read more
Purposes: Our study team developed a behavioural change intervention named LymFit. The LymFit intervention involves a personalized exercise program, bi-weekly kinesiology follow-ups, and the use of activity trackers. The aim of this study is to test if the design of the intervention is feasible and acceptable. The investigators also aim to test if the intervention is able to promote exercise motivation among young adult lymphoma survivors.
Implications: This 12-week pilot study examines the implementation strategies and clinical relevance of a behavioural change intervention targeting young adult lymphoma survivors. The study results have the potential to map out the optimal design of an effective physical activity intervention in improving cancer outcomes, and optimize post-cancer treatment care coordination among health professionals.
Read the detailed description
Background: Lymphoma and its subtypes are among the most commonly diagnosed cancers in young adults aged 18 to 39. Most types of lymphoma are often treated with curative therapies. Unfortunately, treatment side effects, and unhealthy or sedentary lifestyles can substantially affect quality of life and long-term cancer prognosis outcomes among young adult cancer survivors.
A growing body of evidence reveals significant associations between physical activity and cancer-related outcomes. Evidence suggests that specific frequency, intensity, timing, and types of physical activity can have positive effects on cancer treatment processes and outcomes. Physical activity is also significantly associated with enhanced health-related quality of life among cancer survivors.
Despite sustained efforts in the development and implementation of exercise interventions geared towards specific cancer populations and age groups, evidence suggests that lymphoma survivors' exercise engagements remain suboptimal. This warrants the development of an intervention that is theoretically guided, and specific to cancer type and age, to enhance physical activity levels sufficient to improve cancer outcomes. Grounded in self-determination theory, the Lymfit intervention (an individualized exercise program with bi-weekly kinesiology assessments and an activity tracker device) supports the psychological need satisfaction of competence, relatedness, and autonomy in engaging physical activities.
Purpose: To evaluate the feasibility, acceptability, and preliminary effects of the Lymfit intervention on participants' motivation to engage in exercise among young adult lymphoma survivors.
Methods: This study is a two-armed feasibility pilot randomized controlled trial. A target sample size of 28 young adult lymphoma survivors (at the end of their treatment up to six months post-treatment) will be randomly allocated to receive either the 12-week Lymfit intervention (intervention group; n=14) or be on a wait-list (control group; n=14). Feasibility will be assessed by examining criteria related to recruitment, randomization, retention, questionnaire completion, and intervention fidelity. Acceptability will be assessed by examining participant satisfaction with the intervention and the perceived suitability of intervention delivery procedures. Preliminary effects will be assessed using self-report questionnaires at baseline and post-intervention with four study outcomes: psychological need satisfaction, exercise motivation, physical activity level, and quality of life.
Implications: This study examines the feasibility and acceptability of the Lymfit intervention. The results of this study are expected to help in mapping out the optimal design of an effective exercise program for improving cancer outcomes and quality of life in young adults with lymphoma. If the Lymfit intervention shows desired effects, it will have to potential to offer nursing professionals an alternative care option to enhance the quality of post-treatment young adults cancer survivorship care.
- Conditions
- Cancer Survivors, Lymphoma
- Being tested
- Lymfit Intervention, Wait-list control
- Keywords
- Cancer survivorship, Quality of Life, Motivation, Physical Activity
- 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 InterventionBehavioural
Participants will be allocated a pre-registered Inspire II / Charge IV model Fitbit. The research team will reach out to the participant via videoconferencing and help them to: download the Fitbit smartphone application; log-in using the anonymous study identification information; and pair their Fitbit with their smartphone application.
A 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, plus an acceptability assessment survey.
Wait-list 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 intervention | Experimental | Participants randomized to the intervention group will be allocated a pre-registered Inspire II model Fitbit. The kinesiologist will design a personalized exercise prescription for the participant. The kinesiologist will follow up with the participants every 2 weeks for 3 months to discuss their progress and to modify or advance their exercise prescriptions as needed. Receives: Behavioral: Lymfit Intervention |
| Wait-list control arm | Other | The control group participants will begin receiving the Lymfit intervention 3 months after they sign the consent form. Receives: Behavioral: Wait-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate from baseline to end of intervention
Measured by calculating the percentage of participants completing the post-intervention survey (retained in the study).
Measured: 3 months
Acceptability of the study procedures assessed using a set of self-report items
10 self-report items examining participant satisfaction with the intervention and perceived suitability of intervention delivery procedures. The items are assessed using a Likert scale ranging from "1. very dissatisfied" to "5. very satisfied".
Measured: 3 months
Secondary outcomes (4)
Change from baseline Psychological Need Satisfaction assessed by The Psychological Need Satisfaction in Exercise (PNSE) scale
The PNSE comprises 18 items and each item is assessed on a six-point Likert scale from false (1) to true (6). There are six items corresponding to each of the three subscales which measure perceived support for competence, autonomy, and relatedness. Subscale scores (ranging from 1 to 6, with higher scores indicating better outcome) are calculated by averaging the scores for the six items that comprise each scale. A mean score of the full scale will also be calculated to represent the overall satisfaction of psychological needs.
Measured: 3 months
Change from baseline Exercise motivation assessed by the Behavioral Regulation in Exercise Questionnaire (BREQ-3)
The multidimensional BREQ-3 instrument comprises 24 items and six subscales each subscale will assess one form of behavioral regulation (i.e., amotivation, external regulation, introjection, identification, integration, and intrinsic regulation). Each question is scored on a five-point Likert scale from not true for me (0) to very true for me (4). The subscales will be weighted to provide an overall estimate of behavioral regulation, the relative autonomy index (RAI), for which higher scores reflect more self-determination.
Measured: 3 months
Change from baseline Exercise level assessed by the Godin-Shephard leisure-time physical activity questionnaire (LTPA-Q)
The LTPA-Q is a 3-item instrument, it asks individuals to recall the number of times in the past seven days they have performed any strenuous, moderate, and mild physical activity of more than 15 minutes in duration.
Measured: 3 months
Change from baseline Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-Preference)
The PROMIS-Preference is a 31-item instrument assessing 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), and Cognitive Function Abilities (2 items). Raw scores generated for each domain are transformed into T scores; higher PROMIS T scores indicate greater endorsement of the construct being assessed.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Feb 2022
- Primary completion1 Mar 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies 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
- 26 participants (actual)
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
- NCT05259657
- Sponsor's protocol ID
- MP-05-2021-2560
- Acronym
- Lymfit
- Status last verified
- Apr 2024
- First submitted
- 8 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
- Yes: Publishing study protocol
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
- Feasibility, Acceptability, and Preliminary Effects of a Physical Activity Intervention on Psychological Need Satisfaction, Exercise Motivation, Physical Activity Level, and Quality of Life: A Pilot Randomized Controlled Trial Among Young Adult Lymphoma Survivors
- ClinicalTrials.gov ID
- NCT05259657
- Acronym / sponsor ID
- Lymfit / MP-05-2021-2560
- Conditions
- Cancer Survivors, Lymphoma
- Keywords
- Cancer survivorship, Quality of Life, Motivation, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- 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
- 1 Feb 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 28 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.
Background: Lymphoma is one of the most diagnosed cancers in young adults aged 18 to 39. Lymphoma is highly treatable, and the survival rate is often high. Yet, cancer treatments can be toxic, and their side effects can negatively impact the quality of life among cancer survivors. The current research suggests that being active after treatment can improve cancer outcomes. For instance, reducing cancer-related fatigue, anxiety, depression, and improving sleep quality and survival. Physical activities can greatly improve the quality of life after cancer treatment.
Knowledge Gap: Young adults are unique from cancer patients of other age groups. Young adults need stage-of-life-specific, person-centred cancer and survivorship care. Despite knowing that exercise is beneficial in improving cancer outcomes, cancer survivors' engagement and adherence to exercise guidelines remain poor. It is crucial to develop an effective intervention that can motivate lymphoma patients to be active after treatment.
Purposes: Our study team developed a behavioural change intervention named LymFit. The LymFit intervention involves a personalized exercise program, bi-weekly kinesiology follow-ups, and the use of activity trackers. The aim of this study is to test if the design of the intervention is feasible and acceptable. The investigators also aim to test if the intervention is able to promote exercise motivation among young adult lymphoma survivors.
Implications: This 12-week pilot study examines the implementation strategies and clinical relevance of a behavioural change intervention targeting young adult lymphoma survivors. The study results have the potential to map out the optimal design of an effective physical activity intervention in improving cancer outcomes, and optimize post-cancer treatment care coordination among health professionals.
Detailed description
Background: Lymphoma and its subtypes are among the most commonly diagnosed cancers in young adults aged 18 to 39. Most types of lymphoma are often treated with curative therapies. Unfortunately, treatment side effects, and unhealthy or sedentary lifestyles can substantially affect quality of life and long-term cancer prognosis outcomes among young adult cancer survivors.
A growing body of evidence reveals significant associations between physical activity and cancer-related outcomes. Evidence suggests that specific frequency, intensity, timing, and types of physical activity can have positive effects on cancer treatment processes and outcomes. Physical activity is also significantly associated with enhanced health-related quality of life among cancer survivors.
Despite sustained efforts in the development and implementation of exercise interventions geared towards specific cancer populations and age groups, evidence suggests that lymphoma survivors' exercise engagements remain suboptimal. This warrants the development of an intervention that is theoretically guided, and specific to cancer type and age, to enhance physical activity levels sufficient to improve cancer outcomes. Grounded in self-determination theory, the Lymfit intervention (an individualized exercise program with bi-weekly kinesiology assessments and an activity tracker device) supports the psychological need satisfaction of competence, relatedness, and autonomy in engaging physical activities.
Purpose: To evaluate the feasibility, acceptability, and preliminary effects of the Lymfit intervention on participants' motivation to engage in exercise among young adult lymphoma survivors.
Methods: This study is a two-armed feasibility pilot randomized controlled trial. A target sample size of 28 young adult lymphoma survivors (at the end of their treatment up to six months post-treatment) will be randomly allocated to receive either the 12-week Lymfit intervention (intervention group; n=14) or be on a wait-list (control group; n=14). Feasibility will be assessed by examining criteria related to recruitment, randomization, retention, questionnaire completion, and intervention fidelity. Acceptability will be assessed by examining participant satisfaction with the intervention and the perceived suitability of intervention delivery procedures. Preliminary effects will be assessed using self-report questionnaires at baseline and post-intervention with four study outcomes: psychological need satisfaction, exercise motivation, physical activity level, and quality of life.
Implications: This study examines the feasibility and acceptability of the Lymfit intervention. The results of this study are expected to help in mapping out the optimal design of an effective exercise program for improving cancer outcomes and quality of life in young adults with lymphoma. If the Lymfit intervention shows desired effects, it will have to potential to offer nursing professionals an alternative care option to enhance the quality of post-treatment young adults cancer survivorship care.
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 intervention | Experimental | Behavioral: Lymfit InterventionParticipants randomized to the intervention group will be allocated a pre-registered Inspire II model Fitbit. The kinesiologist will design a personalized exercise prescription for the participant. The kinesiologist will follow up with the participants every 2 weeks for 3 months to discuss their progress and to modify or advance their exercise prescriptions as needed. |
| Wait-list control arm | Other | Behavioral: Wait-list controlThe control group participants will begin receiving the Lymfit intervention 3 months after they sign the consent form. |
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 18 to 39
- Receiving or have received chemotherapy with curative intent within the past six months
- Own a smartphone that is able to download the Fitbit application
- Have an internet connection at home that supports participation in coaching sessions via videoconferencing and the ability to complete the study questionnaires online
- Proficient in either French or English
Key exclusion criteria (1 listed)
- 1) Have any contra-indications to moderate to vigorous levels of exercise
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 InterventionParticipants will be allocated a pre-registered Inspire II / Charge IV model Fitbit. The research team will reach out to the participant via videoconferencing and help them to: download the Fitbit smartphone application; log-in using the anonymous study identification information; and pair their Fitbit with their smartphone application. A 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, plus an acceptability assessment survey. | Behavioural | Lymfit intervention |
| Wait-list 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 | Wait-list control arm |
Primary outcome
Retention rate from baseline to end of intervention
Time frame: 3 months
Measured by calculating the percentage of participants completing the post-intervention survey (retained in the study).
Acceptability of the study procedures assessed using a set of self-report items
Time frame: 3 months
10 self-report items examining participant satisfaction with the intervention and perceived suitability of intervention delivery procedures. The items are assessed using a Likert scale ranging from "1. very dissatisfied" to "5. very satisfied".
4 secondary outcomes
Change from baseline Psychological Need Satisfaction assessed by The Psychological Need Satisfaction in Exercise (PNSE) scale
Time frame: 3 months
Change from baseline Exercise motivation assessed by the Behavioral Regulation in Exercise Questionnaire (BREQ-3)
Time frame: 3 months
Change from baseline Exercise level assessed by the Godin-Shephard leisure-time physical activity questionnaire (LTPA-Q)
Time frame: 3 months
Change from baseline Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-Preference)
Time frame: 3 months
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 5 Apr 2024.
- Individual participant dataSharing planned: Yes. Publishing study protocol
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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 Cancer Survivors and Lymphoma, 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 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 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?
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?
Retention rate from baseline to end of intervention (time frame: 3 months). The study lists 2 primary outcomes in all. 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.