Proof-of-concept Lymfif (QI_LF)

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life
• Intervention / Treatment: Behavioral: Lymfit intervention

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A 2A7
      • Jewish General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Lymfit intervention; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: McGill University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2021
• Primary Completion (ACTUAL): November 1, 2021
• Study Completion (ACTUAL): February 1, 2022

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (ACTUAL): September 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 17, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Quality of Life; cancer survivors
• Other Study ID Numbers: QI_LF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No