Proof-of-concept Lymfif

Quality of Life Clinical Trial

— QI_LF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05546489
• Other study ID #: QI_LF
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: September 2022
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life

Intervention

Behavioral:
• Lymfit intervention
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.

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fear of Cancer Recurrence : changes from baseline to post-intervention	Fear of Cancer Recurrence Inventory 42 items	12 weeks
Secondary	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