Proof-of-concept Lymfif

Not Applicable

Completed

• Conditions: Quality of Life

• Registration Number: NCT05546489
• Lead Sponsor: McGill University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2021-11-01
• Study Completion: 2022-02-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-16
• Last Update Submitted: 2022-09-17
• Study First Posted: 2022-09-19
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Quality of Life : changes from baseline to post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Fear of Cancer Recurrence : changes from baseline to post-intervention	12 weeks	Fear of Cancer Recurrence Inventory 42 items
Fear related to the pandemic : changes from baseline to post-intervention	12 weeks	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.

Trial Locations

Locations (1)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada