Breast CancerNCT04064892
Physical Activity Intervention for Young Cancer Survivors
A study testing Exercise Intervention in people with Breast Cancer and Quality of Life, run by University of California, San Diego at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Breast Cancer, Quality of Life, Physical Activity
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: Physical Activity Interventions 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.
Read the detailed description
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
- Breast Cancer, Quality of Life, Physical Activity
- Being tested
- Exercise Intervention
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | Participants will receive a 12-week, individually-tailored, video conference-based physical activity intervention Receives: Behavioral: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
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.
Measured: Baseline to 12 weeks
Secondary outcomes (3)
Body Image Scale
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.
Measured: Baseline to 12 weeks
Female Sexual Function Index
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.
Measured: Baseline to 12 weeks
PROMIS Cancer - Fatigue
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.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 Sep 2019
- Primary completion31 Aug 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Haus of Volta
- Responsible party
- Principal investigator, Sheri Hartman, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064892
- Sponsor's protocol ID
- 181367
- Status last verified
- Nov 2020
- First submitted
- 19 Aug 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36479658Weiner 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.
PubMed 32673270
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Interventions for Young Cancer Survivors
- ClinicalTrials.gov ID
- NCT04064892
- Acronym / sponsor ID
- 181367
- Conditions
- Breast Cancer, Quality of Life, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Haus of Volta
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Exercise InterventionParticipants will receive a 12-week, individually-tailored, video conference-based physical activity intervention |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionThe 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. | Behavioural | Exercise Intervention |
Primary outcome
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.
3 secondary outcomes
Body Image Scale
Time frame: Baseline to 12 weeks
Female Sexual Function Index
Time frame: Baseline to 12 weeks
PROMIS Cancer - Fatigue
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Derived from this study: PubMed 36479658Weiner 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.
- Derived from this study: PubMed 32673270Weiner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Breast Cancer and Quality of Life, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04064892, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.