NCT03322059

Brief Summary

The investigators propose to examine whether linking daily activity with charity-based incentives motivates cancer survivors to initiate and maintain physical activity. Linking daily physical activity goals with a cancer specific charity incentive may provide a uniquely salient motivator that promotes increased physical activity among cancer survivors. The investigators will examine whether using activity monitors in combination with charitable incentives leads to greater increases in physical activity compared to activity monitors alone. Target participants includes cancer survivors who are not already active. Physical activity (e.g., steps per day, time in moderate-intensity activity) will be examined at baseline and following a 12-week intervention period using an activPAL accelerometer. After the baseline assessment, both groups will receive a fitbit monitor and informational material designed to increase physical activity. Participants in the fitbit+charity group will have donations made in their name to a cancer charity if they meet daily step goals. Physical activity levels will be monitored using the fitbit device for 6-weeks following the formal intervention period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

October 13, 2017

Last Update Submit

July 22, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Daily steps

    Daily steps as measured by activPAL

    12 weeks - change from baseline to 12 weeks

Secondary Outcomes (24)

  • Participant retention

    12 weeks

  • Intervention Reach

    Baseline

  • Step goal adherence

    1-12 weeks

  • Daily Steps

    baseline to 12 weeks

  • Sleep

    baseline to 12 weeks

  • +19 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Participants will receive a weekly email with a step goal that will increase 10% beyond the previous weeks values.

Behavioral: Control

Intervention

EXPERIMENTAL

The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Participants will receive a weekly email with a step goal that will increase 10% beyond the previous weeks values. Participants will be in the form of a charitable donation in their name to a cancer charity.

Behavioral: Experimental

Interventions

ExperimentalBEHAVIORAL

Participants will receive a fitbit and lifestyle counseling to increase steps. Weekly newsletter for first 6 weeks, bi-weekly for remaining weeks with behavioral content designed to increase physical activity (e.g., barriers, SMART goals). They will also receive a donation to a cancer charity of their choice if they meet daily step goals.

Also known as: Fitbit+incentives
Intervention
ControlBEHAVIORAL

Participants will receive a fitbit and lifestyle counseling to increase steps. Weekly newsletter for first 6 weeks, bi-weekly for remaining weeks with behavioral content designed to increase physical activity (e.g., barriers, SMART goals).

Also known as: Fitbit-only
Control

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults ≥ 18 years and \<50 y, with diagnosed Adolescent or Young Adult cancer (diagnosed between 15-39y of age);
  • ≥ 6 months post-cancer treatment
  • English speaking
  • Participate in \<60 minutes of MVPA/week
  • Own a smartphone
  • Have access to computer
  • Participants must also pass a physical activity readiness questionnaire or receive medical clearance from their primary care physician or oncologist.

You may not qualify if:

  • Joint, cardiovascular, or respiratory problem(s) precluding physical activity
  • Metastatic disease
  • Planned elective surgery or pregnancy during intervention/follow-up that would interfere with participation (e.g., breast reconstructive surgery).
  • Already using a wearable device \>5 days per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Polytechnic State University

San Luis Obispo, California, 94307, United States

Location

Related Publications (1)

  • Keadle SK, Meuter L, Phelan S, Phillips SM. Charity-based incentives motivate young adult cancer survivors to increase physical activity: a pilot randomized clinical trial. J Behav Med. 2021 Oct;44(5):682-693. doi: 10.1007/s10865-021-00218-w. Epub 2021 Apr 7.

MeSH Terms

Conditions

NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 13, 2017

First Posted

October 26, 2017

Study Start

November 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations