Clinical trial NCT03671304: Mobile Intervention - Physical Activity in Cancer Treatment
Official title: Mobile Intervention - Physical Activity in Cancer Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Carcinoma, Renal Cell
Keywords: renal call carcinoma
exercise
physical activity
mobile intervention
just-in-time adaptive intervention
affective framing
intention planning
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Simmons Cancer Center
First posted: 2018-09-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Physical Activity (Daily Step Count)
timeFrame: 8 weeks
Secondary outcomes:
measure: Fitbit Wear Compliance
timeFrame: 8 weeks
measure: Fitbit Response Compliance
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern
name: Chad Rethorst, BS
role: PRINCIPAL_INVESTIGATOR
References: