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OpenTrials
Completed

NCT Number: NCT05546489

Proof-of-concept Lymfif

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

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Key information

Conditions

Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jewish General Hospital

Montreal, Quebec, H3A 2A7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lymfit Intervention

Behavioral

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.

Primary outcomes

  1. Quality of Life : changes from baseline to post-intervention

    Time frame: 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 outcomes

  1. Fear of Cancer Recurrence : changes from baseline to post-intervention

    Time frame: 12 weeks

    Fear of Cancer Recurrence Inventory 42 items

  2. Fear related to the pandemic : changes from baseline to post-intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

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

Acronym: QI_LF

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 19, 2022
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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