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Physical Activity Intervention for Young Cancer Survivors

NCT ID: NCT04064892

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-09-30

Brief Summary

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The proposed mixed methods pilot study will enroll 20 young breast cancer survivors into a 12-week technology-based, remotely-delivered, peer-moderated physical activity program to examine the effects of the intervention on objectively measured physical activity and multiple aspects of quality of life; and conduct qualitative analyses to refine the intervention for a future randomized controlled trial.

Detailed Description

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Young breast cancer survivors (i.e. those \< 50 years old) have lower survival rates than their older counterparts and experience unique physical and mental challenges associated with their cancer treatments. Depression, anxiety, and poor body image are common in young breast cancer survivors. Research in older breast cancer survivors has shown that physical activity can decrease cancer recurrence and mortality, and improve many aspects of quality of life. Few physical activity intervention studies have been conducted in young breast cancer survivors, despite the fact that young survivors would be best served by age-specific interventions designed to target their needs. Remotely-delivered, technology-based interventions may be important to help young breast cancer survivors overcome unique barriers to increasing physical activity and improving quality of life.

The study aims are: 1) Explore the feasibility and acceptability of a technology-based, remotely-delivered, peer-moderated physical activity intervention for young breast cancer survivors; 2a) Assess the invention's impact on change in physical activity; and 2b) Measure the intervention's effect on multiple aspects of quality of life

Conditions

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Breast Cancer Quality of Life Physical Activity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise Intervention

Participants will receive a 12-week, individually-tailored, video conference-based physical activity intervention

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

The intervention will use peer mentors, motivational interviewing, and technology (Fitbit, Fitbit Coach App, \& Fitbit message board) to support behavior change. All participants will receive phone or video calls from their peer mentors every other week, and interact with their peer mentor and other participants through a private Fitbit message board at least weekly. Peer mentors will use Fitbit data to identify participants who need additional support to increase their activity.

Interventions

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Exercise Intervention

The intervention will use peer mentors, motivational interviewing, and technology (Fitbit, Fitbit Coach App, \& Fitbit message board) to support behavior change. All participants will receive phone or video calls from their peer mentors every other week, and interact with their peer mentor and other participants through a private Fitbit message board at least weekly. Peer mentors will use Fitbit data to identify participants who need additional support to increase their activity.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with breast cancer between 18-49 years old
* Completed active treatment (chemotherapy, radiation) at least 6 months prior to enrollment
* Self-report low levels of moderate to vigorous physical activity each week
* Accessible by phone or video chat
* Have a Fitbit compatible cellphone, tablet, or laptop with Internet

Exclusion Criteria

* medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention
* currently pregnant
* unable to commit to intervention schedule
* prisoner
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Haus of Volta

UNKNOWN

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Sheri Hartman

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, San Diego

La Jolla, California, United States

Site Status

Countries

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United States

References

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Weiner LS, Nagel S, Irene Su H, Hurst S, Levy SS, Arredondo EM, Hekler E, Hartman SJ. A remotely delivered, peer-led intervention to improve physical activity and quality of life in younger breast cancer survivors. J Behav Med. 2023 Aug;46(4):578-593. doi: 10.1007/s10865-022-00381-8. Epub 2022 Dec 7.

Reference Type DERIVED
PMID: 36479658 (View on PubMed)

Weiner LS, Nagel S, Su HI, Hurst S, Hartman SJ. A Remotely Delivered, Peer-Led Physical Activity Intervention for Younger Breast Cancer Survivors (Pink Body Spirit): Protocol for a Feasibility Study and Mixed Methods Process Evaluation. JMIR Res Protoc. 2020 Jul 8;9(7):e18420. doi: 10.2196/18420.

Reference Type DERIVED
PMID: 32673270 (View on PubMed)

Other Identifiers

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181367

Identifier Type: -

Identifier Source: org_study_id