NCT03548636

Brief Summary

The purpose of this research is to implement and evaluate the feasibility of Project MOVE, a program aimed to increase physical activity among breast cancer survivors through microgrants and financial incentives.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

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

Study Start

First participant enrolled

September 17, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
Last Updated

June 7, 2018

Status Verified

June 1, 2018

Enrollment Period

1.5 years

First QC Date

May 8, 2018

Last Update Submit

June 6, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • Program Feasibility (questionnaire)

    Program feasibility will be evaluated using mixed-methods, including a questionnaire, focus groups and semi-structured telephone interviews. A 5-point Likert-scale questionnaire with 1 being "strongly disagree" and 5 being "strongly agree" will be one method used to measure feasibility. Questions will focus on program satisfaction, program appropriateness and participant's perceived confidence to engage in physical activity and continue to engage in physical activity in the long term.

    Post-intervention (6 months)

  • Program Feasibility (focus groups)

    Program feasibility will also be measured using focus groups. Focus groups with each of the Project MOVE groups (ranging 8 to 12 participants per group) will be conducted at the 6-month follow-up. All group members will be invited to participate. Questions will pertain to participants' experiences of Project MOVE specific to adoption, implementation, and maintenance. The focus groups will be audio recorded with a digital SonyTM recorder (ICD-PX333) and transcribed verbatim.

    Post-intervention (6 months)

  • Program Feasibility (interviews)

    Program feasibility will also be measured using semi-structured interviews with each of the group leaders. Phone interviews will be scheduled within 1-4 weeks after the 6-month follow-up data collection period. Open ended questions will be utilized and will focus on the microgrant application process, challenges and enablers to leading a Project MOVE group, and the leader's perception of group member's experiences with Project MOVE. Phone interviews will be recorded using the digital SonyTM recorder (ICD-PX333) and transcribed verbatim.

    1-4 weeks post-intervention 6 month follow-up

Secondary Outcomes (8)

  • Physical Activity Behaviour (Objective)

    Baseline, Post-intervention (6 months) and 12-month follow-up

  • Physical Activity Behaviour (Subjective)

    Baseline, Post-intervention (6 months) and 12-month follow-up

  • Anthropometrics

    Baseline, Post-intervention (6 months) and 12-month follow-up

  • Sedentary Behaviour (Objective)

    Baseline, Post-intervention (6 months) and 12-month follow-up

  • Sedentary Behaviour (Subjective)

    Baseline, Post-intervention (6 months) and 12-month follow-up

  • +3 more secondary outcomes

Study Arms (1)

Single-Arm Feasibility Study

EXPERIMENTAL

Participant determined 6-month physical activity program

Behavioral: Single-Arm Feasibility Study

Interventions

Groups of 8 to 12 participants, consisting of \>50% breast cancer survivors, were invited to apply for up to $2000 to enable access to equipment, resources, facilities, instruction and/or transportation to implement a physical activity intervention. Applicants were assessed by a Grant Review Panel. Successful applicants were informed that they would receive an additional $500 incentive if they increased their group's mean physical activity at six month follow-up (assessed via accelerometry).

Single-Arm Feasibility Study

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female breast cancer survivors
  • + years old,
  • Residing in the Okanagan region of British Columbia, Canada

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Caperchione CM, Sabiston CM, Stolp S, Bottorff JL, Campbell KL, Eves ND, Ellard SL, Gotay C, Sharp P, Pullen T, Fitzpatrick KM. A preliminary trial examining a 'real world' approach for increasing physical activity among breast cancer survivors: findings from project MOVE. BMC Cancer. 2019 Mar 27;19(1):272. doi: 10.1186/s12885-019-5470-2.

Study Officials

  • Cristina Caperchione, PhD

    The University of British Columbia Okanagan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 8, 2018

First Posted

June 7, 2018

Study Start

September 17, 2015

Primary Completion

March 11, 2017

Study Completion

March 11, 2017

Last Updated

June 7, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Only the principal investigators and UBC research team members will have access to the raw data. CO-I's external to UBC will not require access to raw participant data. Any data that are shared will be aggregate data and have all identifiers removed. All of these individuals have training in issues concerning privacy, confidentiality, and are aware of their responsibilities to maintain these.