Mobile Intervention - Physical Activity in Cancer Treatment

Aim 1. Determine the feasibility and acceptability of the proposed mobile technology intervention to increase physical activity patients receiving treatment for renal cell carcinoma.

Aim 2. Evaluate the effect of the proposed intervention components (affective framing, intention planning, and goal-setting) on changes in physical activity.

Study Overview

• Status: Terminated
• Conditions: Carcinoma, Renal Cell
• Intervention / Treatment: Device: Fitbit Versa

Detailed Description

Recent analyses have indicated that physical activity reduces mortality risk among patients with RCC.1. Physical activity also provides additional benefits for patients undergoing treatment for cancer such as improved quality of life and sleep, and reduced treatment-related fatigue. However, individuals receiving treatment for renal cell carcinoma (RCC) often fail to engage in sufficient physical activity. Many cancer survivors experience a decrease in their physical activity after diagnosis2 and the majority of RCC survivors do not meet the recommended guidelines for physical activity.3 Traditional physical activity interventions require significant resources and present substantial barriers for participants (travel, time commitments, etc.). In contrast, mobile technologies enable delivery of interventions with significantly fewer resources. These technologies also facilitate the delivery of just-in-time adaptive interventions (JITAIs) in which intervention support is provided at only at times when an opportunity for positive changes exists.4 The purpose of this support the development of a JITAI in RCC patients. Evaluation of the acceptability and efficacy of three intervention strategies (affective framing, intention planning, goal-setting, and savoring) will determine their inclusion in the JITAI.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75063
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ages 18 years or older
2. Diagnosed with RCC
3. < 150 minutes of weekly moderate-to-vigorous physical activity
4. Own a smartphone (required for syncing the Fitbit device).

Exclusion Criteria:

1. Medical condition contraindicating exercise participation
2. Cognitively unable to give informed consent.
3. Unable to read and communicate in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Just-in-time Adaptive Intervention; Participants will receive a Fitbit Versa and instructions on its use. The study design is not a traditional randomized controlled trial in which participants are randomized to either the intervention or control group. Instead the study utilizes a microrandomized design. This is a within-subjects design in which participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days.

Device: Fitbit Versa; Participants will receive a Fitbit Versa and instructions on its use. Participants will be asked to wear the device for eight weeks, removing it only for charging and when engaging in activities in which the device could be submerged in water (bathing, swimming, etc.). At enrollment, participants will indicate a preferred time to receive affective framing messages and EMA prompts (morning), and intention planning prompts (evenings). Participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity (daily step count)	Physical Activity (daily step count) will be measured with the Fitbit.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fitbit wear compliance	Assessment of participant compliance with the intervention (days wearing the Fitbit) to determine feasibility for future trials.	1 year
Fitbit response compliance	Assessment of participant compliance with the intervention (response rate to intervention prompts) to determine feasibility for future trials.	1 year

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Simmons Cancer Center
• Investigators: Principal Investigator: Chad Rethorst, BS, UT Southwestern

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): December 22, 2021
• Study Completion (Actual): December 22, 2021

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; exercise; renal call carcinoma; mobile intervention; just-in-time adaptive intervention; affective framing; intention planning
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: STU 072018-088

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes