Mobile Intervention - Physical Activity in Cancer Treatment

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT03671304

Collaborator

Simmons Cancer Center (Other)

Enrollment

Location

Arm

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell	Device: Fitbit Versa	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

8 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.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 :

Nov 20, 2020

Actual Primary Completion Date :

Dec 22, 2021

Actual Study Completion Date :

Dec 22, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Physical Activity (daily step count) [1 year]
Physical Activity (daily step count) will be measured with the Fitbit.

Secondary Outcome Measures

Fitbit wear compliance [1 year]
Assessment of participant compliance with the intervention (days wearing the Fitbit) to determine feasibility for future trials.
Fitbit response compliance [1 year]
Assessment of participant compliance with the intervention (response rate to intervention prompts) to determine feasibility for future trials.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75063

Sponsors and Collaborators

University of Texas Southwestern Medical Center
Simmons Cancer Center

Investigators

Principal Investigator: Chad Rethorst, BS, UT Southwestern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Sep 14, 2018

Last Update Posted:

Mar 9, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Muhammad Beg, ASSOC PROFESSOR, University of Texas Southwestern Medical Center

just-in-time adaptive intervention

affective framing

intention planning

Additional relevant MeSH terms:

Carcinoma, Renal Cell

Study Results

No Results Posted as of Mar 9, 2022