Clinical trial NCT05259657: Feasibility, Acceptability, and Preliminary Effects of Lymfit
Official title: Feasibility, Acceptability, and Preliminary Effects of a Physical Activity Intervention on Psychological Need Satisfaction, Exercise Motivation, Physical Activity Level, and Quality of Life: A Pilot Randomized Controlled Trial Among Young Adult Lymphoma Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivors
Lymphoma
Keywords: Cancer survivorship
Quality of Life
Motivation
Physical Activity
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Jewish General Hospital
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted: 2022-02-28
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Background: Lymphoma and its subtypes are among the most commonly diagnosed cancers in young adults aged 18 to 39. Most types of lymphoma are often treated with curative therapies. Unfortunately, treatment side effects, and unhealthy or sedentary lifestyles can substantially affect quality of life and long-term cancer prognosis outcomes among young adult cancer survivors.

A growing body of evidence reveals significant associations between physical activity and cancer-related outcomes. Evidence suggests that specific frequency, intensity, timing, and types of physical activity can have positive effects on cancer treatment processes and outcomes. Physical activity is also significantly associated with enhanced health-related quality of life among cancer survivors.

Despite sustained efforts in the development and implementation of exercise interventions geared towards specific cancer populations and age groups, evidence suggests that lymphoma survivors' exercise engagements remain suboptimal. This warrants the development of an intervention that is theoretically guided, and specific to cancer type and age, to enhance physical activity levels sufficient to improve cancer outcomes. Grounded in self-determination theory, the Lymfit intervention (an individualized exercise program with bi-weekly kinesiology assessments and an activity tracker device) supports the psychological need satisfaction of competence, relatedness, and autonomy in engaging physical activities.

Purpose: To evaluate the feasibility, acceptability, and preliminary effects of the Lymfit intervention on participants' motivation to engage in exercise among young adult lymphoma survivors.

Methods: This study is a two-armed feasibility pilot randomized controlled trial. A target sample size of 28 young adult lymphoma survivors (at the end of their treatment up to six months post-treatment) will be randomly allocated to receive either the 12-week Lymfit intervention (intervention group; n=14) or be on a wait-list (control group; n=14). Feasibility will be assessed by examining criteria related to recruitment, randomization, retention, questionnaire completion, and intervention fidelity. Acceptability will be assessed by examining participant satisfaction with the intervention and the perceived suitability of intervention delivery procedures. Preliminary effects will be assessed using self-report questionnaires at baseline and post-intervention with four study outcomes: psychological need satisfaction, exercise motivation, physical activity level, and quality of life.

Implications: This study examines the feasibility and acceptability of the Lymfit intervention. The results of this study are expected to help in mapping out the optimal design of an effective exercise program for improving cancer outcomes and quality of life in young adults with lymphoma. If the Lymfit intervention shows desired effects, it will have to potential to offer nursing professionals an alternative care option to enhance the quality of post-treatment young adults cancer survivorship care.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Retention rate from baseline to end of intervention
timeFrame: 3 months
measure: Acceptability of the study procedures assessed using a set of self-report items
timeFrame: 3 months
Secondary outcomes:
measure: Change from baseline Psychological Need Satisfaction assessed by The Psychological Need Satisfaction in Exercise (PNSE) scale
timeFrame: 3 months
measure: Change from baseline Exercise motivation assessed by the Behavioral Regulation in Exercise Questionnaire (BREQ-3)
timeFrame: 3 months
measure: Change from baseline Exercise level assessed by the Godin-Shephard leisure-time physical activity questionnaire (LTPA-Q)
timeFrame: 3 months
measure: Change from baseline Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-Preference)
timeFrame: 3 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References: