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

Primary Purpose

Lymphoma, Cancer Survivors

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lymfit exercise intervention
Waitlist control
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphoma focused on measuring Cancer survivorship, Quality of Life, Physical Activity, Fear of Recurrence, Randomized controlled trial

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Jewish General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Lymfit exercise intervention

Waitlist control

Arm Description

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.

Participants will receive the exact same Lymfit exercise intervention 3 months after they consent to participate in the study.

Outcomes

Primary Outcome Measures

Change of the exercise guideline as determined by comparing the active minutes captured in the Fitbit
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.

Secondary Outcome Measures

Change from baseline multi-dimensional Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System-29
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.
Change from baseline Work Ability assessed by the Work Ability Index (WAI)
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).
Change from baseline Fear of Cancer Recurrence assessed by the Cancer Worry Scale (CWS)
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).

Full Information

First Posted
February 9, 2022
Last Updated
March 14, 2023
Sponsor
McGill University
Collaborators
Jewish General Hospital, McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05257785
Brief Title
Lymfit to Improve the Fitness and Quality of Life in Lymphoma Survivors
Acronym
Lymfit_RCT
Official Title
Lymfit to Improve the Fitness and Quality of Life in Lymphoma Survivors: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
Collaborators
Jewish General Hospital, McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Cancer Survivors
Keywords
Cancer survivorship, Quality of Life, Physical Activity, Fear of Recurrence, Randomized controlled trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lymfit exercise intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist control
Arm Type
Other
Arm Description
Participants will receive the exact same Lymfit exercise intervention 3 months after they consent to participate in the study.
Intervention Type
Behavioral
Intervention Name(s)
Lymfit exercise intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of the exercise guideline as determined by comparing the active minutes captured in the Fitbit
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change from baseline multi-dimensional Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System-29
Description
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.
Time Frame
12 months
Title
Change from baseline Work Ability assessed by the Work Ability Index (WAI)
Description
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).
Time Frame
12 months
Title
Change from baseline Fear of Cancer Recurrence assessed by the Cancer Worry Scale (CWS)
Description
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).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: newly diagnosed lymphoma patients who received an initial diagnosis at the age of age 18-39, approved by their hematologist as having no contra-indications to vigorous exercise, receiving or has received chemotherapy with curative intent within the past 6 months, 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 has an Internet connection at home that supports participation in coaching sessions via videoconferencing (zoom). Exclusion Criteria: The patient has contra-indications to vigorous exercise, the patient doesn't want to wear a fitness tracker due to various concerns (as no Fitbit data could be collected).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Maheu, Ph.D.
Phone
514-616-5954
Email
christine.maheu@mcgill.ca
Facility Information:
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2A7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Maheu
Phone
5146165954
Email
christine.maheu@mcgill.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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