Interrupting Sedentary Time to Improve Cardiometabolic Health and Toxicity in Patients With Lymphoma Receiving Chemotherapy: The iSTAND Trial

Dana-Farber Cancer Institute24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Lymphoma Lymphoma, Hodgkin

Interventions

Interrupted Sedentary Time InterventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ability to understand and the willingness to sign informed consent prior to any study- related procedures. * Patients diagnosed with lymphoma. * Will receive first line R-CHOP or POLA-R-CHP chemotherapy regimens, patients do not need to be within a certain timeframe from diagnosis. * Aged ≥18 years; due to the rarity of the disease in those \<18 years, this age bracket will not be included. * Engaging in ≤60-minutes of structured moderate or vigorous intensity exercise. * Have physician clearance to participate in exercise. * Speak English. * Willing to travel to Dana-Farber Cancer Institute for necessary data collection and exercise sessions. * Access to a phone that can receive text messages. Exclusion Criteria: * Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities likely require supervised exercise for safety, and part of this study involves unsupervised exercise; therefore, for safety reasons, these persons are excluded. * Participate in more than 60 minutes of structured moderate-to-vigorous exercise per week over the last month. Excess additional exercise is a confounding factor in assessing the effect of the current interrupted sedentary time intervention. * Patients receiving treatment for other active malignancies (except basal cell carcinoma). This study is exclusively targeting lymphoma chemotherapy-related effects. * Subjects who in the opinion of the investigators may not be able to comply with the safety monitoring requirements of the study. * Unable to travel to DFCI Longwood campus for necessary data collection and chemotherapy infusions.

Outcomes

Primary Outcomes

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 Outcomes

Participant Glucose Level

Glucose levels will be assessed by constant glucose monitoring where an average of \>180 mg/dl will be considered hyperglycemic.

Time frame: Assessed for one week at each timepoint (baseline & post-intervention).

Participant Insulin Resistance

Insulin resistance will be assessed by calculating Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from fasting blood samples where values \>1.9 will be considered insulin resistant.

Time frame: Assessed for one week at each timepoint (baseline & post-intervention).

Interrupting Sedentary Time to Improve Cardiometabolic Health and Toxicity in Patients With Lymphoma Receiving Chemotherapy: The iSTAND Trial

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts