Feasibility, Acceptability, and Preliminary Effects of Lymfit

NCT05259657 | Completed

• 1 other identifier: MP-05-2021-2560
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Lymphoma is one of the most diagnosed cancers in young adults aged 18 to 39. Lymphoma is highly treatable, and the survival rate is often high. Yet, cancer treatments can be toxic, and their side effects can negatively impact the quality of life among cancer survivors. The current research suggests that being active after treatment can improve cancer outcomes. For instance, reducing cancer-related fatigue, anxiety, depression, and improving sleep quality and survival. Physical activities can greatly improve the quality of life after cancer treatment. Knowledge Gap: Young adults are unique from cancer patients of other age groups. Young adults need stage-of-life-specific, person-centred cancer and survivorship care. Despite knowing that exercise is beneficial in improving cancer outcomes, cancer survivors' engagement and adherence to exercise guidelines remain poor. It is crucial to develop an effective intervention that can motivate lymphoma patients to be active after treatment. Purposes: Our study team developed a behavioural change intervention named LymFit. The LymFit intervention involves a personalized exercise program, bi-weekly kinesiology follow-ups, and the use of activity trackers. The aim of this study is to test if the design of the intervention is feasible and acceptable. The investigators also aim to test if the intervention is able to promote exercise motivation among young adult lymphoma survivors. Implications: This 12-week pilot study examines the implementation strategies and clinical relevance of a behavioural change intervention targeting young adult lymphoma survivors. The study results have the potential to map out the optimal design of an effective physical activity intervention in improving cancer outcomes, and optimize post-cancer treatment care coordination among health professionals.

Conditions

Cancer Survivors; Lymphoma

Keywords

Cancer survivorship; Quality of Life; Motivation; Physical Activity

Outcome Measures

Primary Outcomes (2)

• Retention rate from baseline to end of intervention

  Measured by calculating the percentage of participants completing the post-intervention survey (retained in the study).

  3 months

• Acceptability of the study procedures assessed using a set of self-report items

  10 self-report items examining participant satisfaction with the intervention and perceived suitability of intervention delivery procedures. The items are assessed using a Likert scale ranging from "1. very dissatisfied" to "5. very satisfied".

  3 months

Secondary Outcomes (4)

• Change from baseline Psychological Need Satisfaction assessed by The Psychological Need Satisfaction in Exercise (PNSE) scale

  3 months

• Change from baseline Exercise motivation assessed by the Behavioral Regulation in Exercise Questionnaire (BREQ-3)

  3 months

• Change from baseline Exercise level assessed by the Godin-Shephard leisure-time physical activity questionnaire (LTPA-Q)

  3 months

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

  3 months

Study Arms (2)

Lymfit intervention

EXPERIMENTAL

Participants randomized to the intervention group will be allocated a pre-registered Inspire II model Fitbit. The kinesiologist will design a personalized exercise prescription for the participant. The kinesiologist will follow up with the participants every 2 weeks for 3 months to discuss their progress and to modify or advance their exercise prescriptions as needed.

Behavioral: Lymfit Intervention

Wait-list control arm

OTHER

The control group participants will begin receiving the Lymfit intervention 3 months after they sign the consent form.

Behavioral: Wait-list control

Interventions

Lymfit Intervention BEHAVIORAL

Participants will be allocated a pre-registered Inspire II / Charge IV model Fitbit. The research team will reach out to the participant via videoconferencing and help them to: download the Fitbit smartphone application; log-in using the anonymous study identification information; and pair their Fitbit with their smartphone application. A 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, plus an acceptability assessment survey.

Lymfit intervention

Wait-list control BEHAVIORAL

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.

Wait-list control arm

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Newly diagnosed lymphoma patients who received an initial diagnosis at the age of 18 to 39
• Receiving or have received chemotherapy with curative intent within the past six months
• Own a smartphone that is able to download the Fitbit application
• Have an internet connection at home that supports participation in coaching sessions via videoconferencing and the ability to complete the study questionnaires online
• Proficient in either French or English

You may not qualify if:

• \) Have any contra-indications to moderate to vigorous levels of exercise

Sponsors & Collaborators

• McGill University: lead
• Jewish General Hospital: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3A 2A7, Canada

Location

MeSH Terms

Conditions

Lymphoma; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior

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 8, 2022
• First Posted: February 28, 2022
• Study Start: February 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: will be submitted to the International Journal of Clinical Trials (IJCT) in March 2022
• Access Criteria: Public

Locations

CA (1)