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Mobile Intervention - Physical Activity in Cancer Treatment

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ClinicalTrials.gov Identifier: NCT03671304
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : August 9, 2021
Sponsor:
Collaborator:
Simmons Cancer Center
Information provided by (Responsible Party):
Muhammad Beg, 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.


Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Device: Fitbit Versa Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Mobile Intervention - Physical Activity in Cancer Treatment
Actual Study Start Date : November 20, 2020
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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.





Primary Outcome Measures :
  1. Physical Activity (daily step count) [ Time Frame: 1 year ]
    Physical Activity (daily step count) will be measured with the Fitbit.


Secondary Outcome Measures :
  1. Fitbit wear compliance [ Time Frame: 1 year ]
    Assessment of participant compliance with the intervention (days wearing the Fitbit) to determine feasibility for future trials.

  2. Fitbit response compliance [ Time Frame: 1 year ]
    Assessment of participant compliance with the intervention (response rate to intervention prompts) to determine feasibility for future trials.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671304


Contacts
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Contact: Chad Rethorst, PhD 214-648-0153 Chad.Rethorst@utsouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75063
Contact: Ellen Siglinsky       Ellen.Siglinsky@UTSouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Simmons Cancer Center
Investigators
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Principal Investigator: Chad Rethorst, BS UT Southwestern
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Responsible Party: Muhammad Beg, ASSOC PROFESSOR, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03671304    
Other Study ID Numbers: STU 072018-088
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021

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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
Keywords provided by Muhammad Beg, University of Texas Southwestern Medical Center:
renal call carcinoma
exercise
physical activity
mobile intervention
just-in-time adaptive intervention
affective framing
intention planning
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases