Lymfit to Improve the Fitness and Quality of Life in Lymphoma Survivors (Lymfit_RCT)

April 4, 2024 updated by: Christine Maheu, McGill University

Lymfit to Improve the Fitness and Quality of Life in Lymphoma Survivors: A Randomized Controlled Trial

This randomized control trial seeks to determine whether a tailored and supervised exercise program adopting mobile-health technology will be able to improve fitness and quality of life among lymphoma survivors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Lymphoma is the most common cancer diagnosed in young adults. While curing 80% of patients, lymphoma treatment has a significant impact on young adults' health and psycho-social wellbeing by increasing fatigue and anxiety, risk of cardiovascular disease and other chronic disorders, all of which compromise one's quality of life. Regular exercise has the potential to reduce the side effects associated with cancer treatments. Thus, the most recent guidelines suggest that cancer patients should engage in adapted exercise programs during and after their treatment.

However, these guidelines are not systematically recommended by doctors and are often not followed by patients. Fatigue and lack of motivation are the main barriers to exercise among cancer survivors. Our study aims to identify young adults lymphoma patients and encourage them to adhere to the exercise guidelines with the help of an exercise physiologist and a fitness tracker. The investigators will evaluate the efficacy of these strategies in motivating exercise among young adults lymphoma survivors. Our proposed study carries significant implications for the prevention of complications of treatment for young adults lymphoma survivors.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 2A7

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. newly diagnosed lymphoma patients who received an initial diagnosis at the age of age 18-39,
  2. approved by their hematologist as having no contra-indications to vigorous exercise,
  3. receiving or has received chemotherapy with curative intent within the past 6 months,
  4. own a cellular phone that is able to download the Fitbit app and to complete the study questionnaires online in either French or English, and
  5. has an Internet connection at home that supports participation in coaching sessions via videoconferencing (zoom).

Exclusion Criteria:

  1. The patient has contra-indications to vigorous exercise,
  2. the patient doesn't want to wear a fitness tracker due to various concerns (as no Fitbit data could be collected).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lymfit exercise intervention
Participants randomized to the intervention group will be allocated a pre-registered Fitbit, a personalized exercise prescription designed by the kinesiologist, and 12 weeks of supervision by the kinesiologist.
Behavioral: Lymfit exercise intervention
Participants randomized to this arm will be allocated a pre-registered Inspire II / Charge IV model Fitbit. The kinesiologist of the study will meet with the participants for a baseline fitness assessment. The kinesiologist will examine the baseline physical activity levels, fitness level and sedentary behaviours of the participants, to design a personalized exercise prescription. Within one week after the baseline fitness assessment, the kinesiologist will contact the participants to discuss the exercise prescription. Every two weeks there-after, the kinesiologist will follow up with the participants via videoconferencing to discuss their progress and to modify or advance their exercise prescriptions as needed. Participants will be followed-up at 6 months and 12 months.
Other: Waitlist control
Participants will receive the exact same Lymfit exercise intervention 3 months after they consent to participate in the study.
Behavioral: Waitlist control
Participants will be contacted by the study kinesiologist for a baseline fitness assessment 3 months after they consent, participants will be given a Fitbit, a personalized exercise prescription and receive bi-weekly follow-ups for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the exercise guideline as determined by comparing the active minutes captured in the Fitbit
Time Frame: 3 months
The investigators will determine the percentage of lymphoma patients who adhere to the recommended exercise guidelines for cancer patients at baseline and after the intervention, i.e. compare the minutes of Moderate to vigorous physical activity per week captured in the Fitbit among participants in the intervention arm and waitlist control arm at baseline and 3 months.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline multi-dimensional Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System-29
Time Frame: 12 months
The Patient-Reported Outcomes Measurement Information System-29 is a 29-item instrument assessing multi-dimensional eight domains (29 items) (i.e., anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, ability to participate in social roles and activities, and pain intensity). Raw scores generated for each domain are transformed into T scores; higher T scores indicate greater endorsement of the construct being assessed.
12 months
Change from baseline Work Ability assessed by the Work Ability Index (WAI)
Time Frame: 12 months
The Work Ability Index (WAI) questionnaire (7 items) will be used to collect productivity loss data within clinical trials and is suitable for direct translation into a monetary figure. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor [7-27], moderate [28-36], good (37-43) and excellent (44-49).
12 months
Change from baseline Fear of Cancer Recurrence assessed by the Cancer Worry Scale (CWS)
Time Frame: 12 months
Cancer Worry Scale is a six-item scale designed to measure worry about the risk of developing cancer and the impact of worry on daily functioning. The scale consists of six questions with four response options (1 = not at all or rarely; 2 = sometimes; 3 = often; 4 = almost all the time), such that each individual attains a score ranging from 6 (minimum worry) to 24 (maximum worry).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Collaborators

McGill University Health Centre/Research Institute of the McGill University Health Centre
Jewish General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 25, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-2560

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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