Carcinoma, Renal Cell
Conditions
Keywords
renal call carcinoma, exercise, physical activity, mobile intervention, just-in-time adaptive intervention, affective framing, intention planning
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.
Interventions
DEVICEFitbit 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.
Sponsors
Simmons Cancer Center
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity (Daily Step Count) | 8 weeks | Physical Activity (daily step count) will be measured with the Fitbit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fitbit Wear Compliance | 8 weeks | Assessment of participant compliance with the intervention (days wearing the Fitbit) to determine feasibility for future trials. |
| Fitbit Response Compliance | 8 weeks | Assessment of participant compliance with the intervention (response rate to intervention prompts) to determine feasibility for future trials. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | study terminated | 7 |
Baseline characteristics
| Characteristic | Just-in-time Adaptive Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 65 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Physical Activity (Daily Step Count)
Physical Activity (daily step count) will be measured with the Fitbit.
Time frame: 8 weeks
Population: Collected data was not considered valid to be analyzed as the application utilized with the fitbit was no longer supported and the study did not complete and was terminated.
Secondary
Fitbit Response Compliance
Assessment of participant compliance with the intervention (response rate to intervention prompts) to determine feasibility for future trials.
Time frame: 8 weeks
Population: Collected data was not considered valid to be analyzed as the application utilized with the fitbit was no longer supported and the study did not complete and was terminated.
Secondary
Fitbit Wear Compliance
Assessment of participant compliance with the intervention (days wearing the Fitbit) to determine feasibility for future trials.
Time frame: 8 weeks
Population: Collected data was not considered valid to be analyzed as the application utilized with the fitbit was no longer supported and the study did not complete and was terminated.