Mobile Intervention - Physical Activity in Cancer Treatment

NCT03671304 | Terminated Results FDA Device

• 1 other identifier: STU 072018-088
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Renal Cell

Keywords

renal call carcinoma; exercise; physical activity; mobile intervention; just-in-time adaptive intervention; affective framing; intention planning

Outcome Measures

Primary Outcomes (1)

• Physical Activity (Daily Step Count)

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

  8 weeks

Secondary Outcomes (2)

• Fitbit Wear Compliance

  8 weeks

• Fitbit Response Compliance

  8 weeks

Study Arms (1)

Just-in-time Adaptive Intervention

EXPERIMENTAL

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

Interventions

Fitbit Versa DEVICE

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.

Just-in-time Adaptive Intervention

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Simmons Cancer Center: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75063, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Motor Activity

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Behavior

Results Point of Contact

• Title: Dr. Muhammad Beg
• Organization: UT Southwestern Medical Center

muhammad.beg@utsouthwestern.edu

214-648-4180

Study Officials

• Chad Rethorst, BS

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOC PROFESSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 14, 2018
• Study Start: November 20, 2020
• Primary Completion: December 22, 2021
• Study Completion: December 22, 2021
• Last Updated: February 2, 2023
• Results First Posted: February 2, 2023

Record last verified: 2023-01

Locations

US (1)