Proof-of-concept Lymfif

Study Overview
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Brief Summary
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This proof-of-concept study was to explore the implementation feasibility to deliver the Lymfit intervention to participants remotely during the pandemic.

Official Title
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A Proof-of-concept Study of Lymfit: A Personalized, Virtual Exercise Intervention to Improve Health Outcomes in Lymphoma Survivors in the Pandemic

Conditions
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Quality of Life

Intervention / Treatment
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* Behavioral: Lymfit intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: -1. have any contra-indications to performing physical activities as determined by the hematologist

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lymfit intervention<br>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. | Behavioral: Lymfit intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of Cancer Recurrence : changes from baseline to post-intervention | Fear of Cancer Recurrence Inventory 42 items | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life, cancer survivors