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Mobile Intervention - Physical Activity in Cancer Treatment

Primary Purpose

Carcinoma, Renal Cell

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitbit Versa
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Carcinoma, Renal Cell focused on measuring renal call carcinoma, exercise, physical activity, mobile intervention, just-in-time adaptive intervention, affective framing, intention planning

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Just-in-time Adaptive Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Physical Activity (Daily Step Count)
Physical Activity (daily step count) will be measured with the Fitbit.

Secondary Outcome Measures

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

Full Information

First Posted
September 7, 2018
Last Updated
January 9, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Simmons Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03671304
Brief Title
Mobile Intervention - Physical Activity in Cancer Treatment
Official Title
Mobile Intervention - Physical Activity in Cancer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was prematurely discontinued, the application utilized with the fitbit is no longer being supported.
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
December 22, 2021 (Actual)
Study Completion Date
December 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Simmons Cancer Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell
Keywords
renal call carcinoma, exercise, physical activity, mobile intervention, just-in-time adaptive intervention, affective framing, intention planning

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This project will enroll 50 participants receiving treatment for RCC in an eight-week study. Using a microrandomized design, 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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Just-in-time Adaptive Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Fitbit Versa
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical Activity (Daily Step Count)
Description
Physical Activity (daily step count) will be measured with the Fitbit.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Fitbit Wear Compliance
Description
Assessment of participant compliance with the intervention (days wearing the Fitbit) to determine feasibility for future trials.
Time Frame
8 weeks
Title
Fitbit Response Compliance
Description
Assessment of participant compliance with the intervention (response rate to intervention prompts) to determine feasibility for future trials.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 18 years or older Diagnosed with RCC < 150 minutes of weekly moderate-to-vigorous physical activity Own a smartphone (required for syncing the Fitbit device). Exclusion Criteria: Medical condition contraindicating exercise participation Cognitively unable to give informed consent. Unable to read and communicate in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chad Rethorst, BS
Organizational Affiliation
UT Southwestern
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75063
Country
United States

12. IPD Sharing Statement

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Mobile Intervention - Physical Activity in Cancer Treatment

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