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Completed

NCT Number: NCT04064892

Physical Activity Intervention for Young Cancer Survivors

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Physical Activity Quality of Life Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

La Jolla, California, 92093, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Intervention

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.

Primary outcomes

  1. Physical Activity

    Time frame: Baseline to 12 weeks

    The ActiGraph GT3X+ accelerometer will be used to measure change in minutes of moderate to vigorous physical activity from baseline to 12 weeks. For 7 days around each assessment time point, participants will wear the accelerometer.

Secondary outcomes

  1. Body Image Scale

    Time frame: Baseline to 12 weeks

    The Body Image Scale will be used to measure changes in perceptions of body image from baseline to 12 weeks. Scores range from 0 to 30. A higher score indicates more distress.

  2. Female Sexual Function Index

    Time frame: Baseline to 12 weeks

    The Female Sexual Function Index will be used to measure change in self-reported sexual functioning from baseline to 12 weeks. Scores range from 2 to 36. A higher score indicates fewer problems with sexual functioning.

  3. PROMIS Cancer - Fatigue

    Time frame: Baseline to 12 weeks

    Change in fatigue from baseline to 12 weeks will be assessed via a Patient-Reported Outcome Measurement Information System (PROMIS) computer adaptive test (CAT), PROMIS Cancer- Fatigue. CAT items are dynamically selected for administration from an item bank based upon the respondent's previous answers. Participants will complete 4-12 items. This measure yields a T-Score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher levels of fatigue.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Haus of Volta

Registry information

Official study title

Physical Activity Interventions for Young Cancer Survivors

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 22, 2019
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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