NCT05257785

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable lymphoma

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

2.9 years

First QC Date

February 9, 2022

Last Update Submit

April 4, 2024

Conditions

LymphomaCancer Survivors

Keywords

Cancer survivorshipQuality of LifePhysical ActivityFear of RecurrenceRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (3)

  • Change from baseline multi-dimensional Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System-29

    12 months

  • Change from baseline Work Ability assessed by the Work Ability Index (WAI)

    12 months

  • Change from baseline Fear of Cancer Recurrence assessed by the Cancer Worry Scale (CWS)

    12 months

Study Arms (2)

Lymfit exercise intervention

EXPERIMENTAL

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

Waitlist control

OTHER

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

Behavioral: Waitlist control

Interventions

Lymfit exercise interventionBEHAVIORAL

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.

Lymfit exercise intervention
Waitlist controlBEHAVIORAL

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.

Waitlist control

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3A 2A7, Canada

RECRUITING

MeSH Terms

Conditions

LymphomaMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBehavior

Central Study Contacts

Christine Maheu, Ph.D.

CONTACT

514-616-5954christine.maheu@mcgill.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 25, 2022

Study Start

January 15, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

April 5, 2024

Record last verified: 2024-04

Locations

CA(1)