Mobile Intervention - Physical Activity in Cancer Treatment

Not Applicable

Terminated

• Conditions: Carcinoma, Renal Cell
• Interventions: Device: Fitbit Versa

• Registration Number: NCT03671304
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-14
• Study Start: 2020-11-20
• Primary Completion: 2021-12-22
• Study Completion: 2021-12-22
• Status Verified: 2023-01
• Results First Submitted: 2023-01-09
• Results First Submitted QC: 2023-01-09
• Last Update Submitted: 2023-01-09
• Results First Posted: 2023-02-02
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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).

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Just-in-time Adaptive Intervention	Fitbit Versa	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.

Primary Outcome Measures

Name	Time	Method
Physical Activity (Daily Step Count)	8 weeks	Physical Activity (daily step count) will be measured with the Fitbit.

Secondary Outcome Measures

Name	Time	Method
Fitbit Wear Compliance	8 weeks	Assessment of participant compliance with the intervention (days wearing the Fitbit) to determine feasibility for future trials.
Fitbit Response Compliance	8 weeks	Assessment of participant compliance with the intervention (response rate to intervention prompts) to determine feasibility for future trials.

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States