Mobile Intervention - Physical Activity in Cancer Treatment

Carcinoma, Renal Cell Clinical Trial

Official title:

Mobile Intervention - Physical Activity in Cancer Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03671304
• Other study ID #: STU 072018-088
• Status: Terminated
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: December 22, 2021

Study information

• Verified date: January 2023
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 22, 2021
• Est. primary completion date: December 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Simmons Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity (Daily Step Count)	Physical Activity (daily step count) will be measured with the Fitbit.	8 weeks
Secondary	Fitbit Wear Compliance	Assessment of participant compliance with the intervention (days wearing the Fitbit) to determine feasibility for future trials.	8 weeks
Secondary	Fitbit Response Compliance	Assessment of participant compliance with the intervention (response rate to intervention prompts) to determine feasibility for future trials.	8 weeks