Interrupting Sedentary Time to Improve Cardiometabolic Health and Toxicity in Patients With Lymphoma Receiving Chemotherapy: The iSTAND Trial
Summary
This study aims to see if a 12-week exercise program designed to reduce long periods of inactivity is feasible in newly diagnosed lymphoma participants receiving R-CHOP or POLA-R-CHP chemotherapy treatments, and whether it can improve heart health and reduce chemotherapy drug side effects.
Detailed description
The purpose of this study is to see if a 12-week exercise program designed to reduce long periods of inactivity is feasible in newly diagnosed lymphoma participants receiving R-CHOP or POLA-R-CHP chemotherapy treatments, and whether it can improve heart health and reduce chemotherapy drug side effects. Participants will be randomized into one of two groups: Group A: Interrupted Sedentary Time Intervention vs. Group B: Usual Care Control Group. Randomized means a participant is placed into a study group by chance. The research study procedures include screening for eligibility, assessments of fitness and physical health, blood tests, and questionnaires. Participation in this research study is expected to last about 3 months. It is expected that about 24 people will take part in this research study.
Arms & interventions
- BehavioralInterrupted Sedentary Time Intervention
A 12-week, semi-supervised exercise intervention comprised of reminder prompts, counseling, and activities of walking, cycling, and resistance band exercise for at-home and in-clinic settings. Supervision will be under an exercise trainer. Resistance bands, Libre Pro continuous blood sugar monitor, and Fitbit and ActivPAL trackers will be provided to participants.
Outcome measures
Primary
Intervention Completion Rate (Feasibility)
Intervention feasibility is defined as: 1) A participant completes ≥70% of the supervised activity breaks on at least 3 out of the 4 infusion appointments. 2) A participant completes ≥70% of the prescribed home-based resistance activity breaks on at least 48 days out of the possible 68 days (12 week) intervention (excluding the 4 infusion days and 1 rest day per week) (i.e., meet interrupting sedentary behavior goals across at least 70% of the intervention). 3) A participant completes ≥70% of the prescribed home-based step goals (i.e., \>250 steps per hour) on at least 48 days out of the possible 68 days (12 week) intervention (excluding the 4 infusion days and 1 rest day per week) (i.e., meet interrupting sedentary behavior goals across at least 70% of the intervention).
Time frame: 12 weeks
Refusal Rate
Defined as ≤50% of eligible screened participants refuse to complete intervention.
Time frame: 12 weeks
Retention Rate
Retention of consented participants to study end is ≥70%.
Time frame: 13 weeks
Acceptability of Intervention Measure (AIM) Scale
Assessed by the Acceptability of the Intervention Measures, a 4-item measure rated on a 5-point Likert scale with answers ranging from "Completely disagree" to "Completely agree." A total scores range is 4 to 20 with a higher score indicating greater acceptability. The intervention will be deemed acceptable by participants if ≥70% of participants have a mean score ≥ 4 on the AIM.
Time frame: 13 weeks
Acceptability Exit Survey
The intervention will be deemed acceptable by participants if 1) ≥70% of participants report "agree" or "strongly agree" to the prompt "Participation in this study helped me reduce my daily sedentary time" and 2) ≥70% of participants report "probably" or "yes" to the prompt "I would recommend this program to other patients being treated for cancer."
Time frame: 13 weeks
Secondary
Participant Glucose Level
Time frame: Assessed for one week at each timepoint (baseline & post-intervention).
Participant Insulin Resistance
Time frame: Assessed for one week at each timepoint (baseline & post-intervention).
Eligibility criteria
Study locations (1)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215