Proof-of-concept Lymfif

NCT05546489 | Completed

• 1 other identifier: QI_LF
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Quality of Life

Keywords

Quality of Life; cancer survivors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  12 weeks

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

  12 weeks

Study Arms (1)

Lymfit intervention

EXPERIMENTAL

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

Interventions

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.

Lymfit intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. previously diagnosed with lymphoma
• \. have completed chemotherapy
• \. 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

You may not qualify if:

• have any contra-indications to performing physical activities as determined by the hematologist

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3A 2A7, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: May 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: February 1, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)