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Physical ActivityIMPACTNCT03569605

Promoting Physical Activity in Young Adult Cancer Survivors Using mHealth and Adaptive Tailored Feedback Strategies

A study testing Self-help and Intervention in people with Physical Activity and Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To date, few interventions have been designed specifically to promote physical activity in young adult cancer survivors, nor used novel technologies for delivery; none have been successful in promoting long-term adherence to PA. Read more about this study

Who is it for?
Ages 18 to 39 years
Conditions the study is for
Physical Activity, Neoplasms, Neoplasms by Site
What is being tested?
Self-help and Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteUnited States
Study dates
23 Aug 2018to 29 Jan 2021
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 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Currently age 18-39
  • Diagnosed with invasive malignancy between the ages of 18-39 years
  • Diagnosed with invasive malignancy in the last 10 years with no evidence of progressive disease or second primary cancers
  • Completed active cancer directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention), except may be receiving "maintenance" therapy to prevent recurrences
  • Have the ability to read, write and speak English
  • No pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
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  • Not adhering to the American College of Sports Medicine recommendation of at least 150 moderate-to-vigorous physical activity minutes/week
  • Have access to the Internet on at least a weekly basis
  • Possession and usage of an Internet e-mail address or willingness to sign up for a free email account (e.g., gmail)
  • Have mobile phone with text messaging plan
  • Willing to be randomized to either arm
  • Successful completion of accelerometer-assessed activity (i.e., at least 10 hours/day on 4 of 7 days) and return of the accelerometer in a pre-paid envelope at baseline

Who cannot join

  • History of heart attack or stroke within past 6 months
  • Untreated hypertension, hyperlipidemia, or diabetes, unless permission is provided by their health care provider
  • Health problems which preclude ability to walk for physical activity
  • Report a diagnosis of psychiatric diseases (schizophrenia, bipolar disorder, depression leading to hospitalization in the past year), drug or alcohol dependency.
  • Report a past diagnosis of or treatment for a DSM-IV-TR eating disorder (anorexia nervosa or bulimia nervosa)
  • Current participation in another physical activity or weight control program
Show all 9Show fewer
  • Currently using prescription weight loss medications
  • Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
  • Currently exercising > 150 minutes/week of moderate-to-vigorous intensity physical activity

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

To date, few interventions have been designed specifically to promote physical activity in young adult cancer survivors, nor used novel technologies for delivery; none have been successful in promoting long-term adherence to PA. The purpose of this randomized controlled trial is to test the efficacy of a theory-based, mobile physical activity intervention with adaptive goal-setting and tailored feedback that is aimed at increasing physical activity among young adult cancer survivors.

Read the detailed description

There are over half a million young adult cancer survivors in the United States. Young adult cancer survivors are an underserved and vulnerable subgroup of survivors that experience increased risk over time for obesity and chronic diseases such as diabetes and cardiovascular disease. Increasing physical activity is a promising behavioral intervention that has positive effects on physical function, body composition, cardiovascular fitness, health-related quality of life, and depression, and may prevent cancer recurrence, new cancers and improve survival. To date, few interventions have been designed specifically to promote physical activity in young adult cancer survivors, nor used novel technologies for delivery; none have been successful in promoting long-term adherence to physical activity. This is a randomized controlled trial to test the efficacy of a theory-based, mobile physical activity intervention with adaptive goal-setting and tailored feedback that is aimed at increasing PA among young adult cancer survivors. Young adult cancer survivors (n=280), diagnosed between ages 18-39, will be recruited and randomized into one of two conditions: 1) activity tracker + Facebook group (Self-help) or 2) activity tracker + Facebook group + adaptive goal-setting and tailored feedback (Intervention). Young adult cancer survivors will receive a 6-month intervention followed by an additional 6 months of tapered contacts. Assessments of objectively-measured physical activity and other outcomes will be conducted at baseline, 3, 6, and 12 months.

Being tested
Self-help, Intervention
Keywords
young adult, cancer survivor
Medical subject headings
Motor Activity, Neoplasms, Neoplasms by Site

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-helpBehavioural

    Also called Digital tools

    Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group.

  • InterventionBehavioural

    Also called Digital tools plus

    Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group with the addition of behavioral lessons, adaptive physical activity goals, tailored feedback summaries, and text messages.

Study groups in NCT03569605
Study groupRoleWhat they receive
Self-helpActive comparatorParticipants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group.
Receives: Behavioral: Intervention
InterventionExperimentalParticipants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group, behavioral lessons, adaptive physical activity goals, tailored feedback summaries, and text messages.
Receives: Behavioral: Self-help

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Minutes of total physical activity at 6 months: objective

    Change in objective levels of physical activity, as measured by accelerometry (ActiGraph), from baseline to 6 months. Participants will wear an accelerometer on their wrist during a 7 day period.

    Measured: Baseline, 6 months

Secondary outcomes (17)
  1. Minutes of total physical activity at 6 months: self-report

    Change in self-report levels of physical activity, as measured by a modified version of the Godin Leisure Time Exercise Questionnaire, from baseline to 6 months. Participants report frequency of light, moderate and vigorous exercise, and average duration (minutes/week) for light, moderate and vigorous exercise bouts in a typical week. Scores for light, moderate and vigorous exercise are combined to compute total physical activity minutes/week.

    Measured: Baseline, 6 months

  2. Minutes of total physical activity at 12 months: objective

    Change in levels of physical activity, as measured by accelerometry (ActiGraph), from baseline to 6 and 12 months. Participants will wear an accelerometer on their wrist during a 7 day period.

    Measured: Baseline, 6 months, 12 months

  3. Minutes of total physical activity at 12 months: self-report

    Change in levels of physical activity, as measured by a modified version of the Godin Leisure Time Exercise Questionnaire, from baseline to 6 and 12 months. Participants report frequency of light, moderate and vigorous exercise, and average duration (minutes) for light, moderate and vigorous exercise bouts in a typical week. Scores for light, moderate and vigorous exercise are combined to compute total physical activity minutes/week.

    Measured: Baseline, 6 months, 12 months

  4. Minutes of light-intensity physical activity: objective

    Change in levels of light-intensity physical activity, as measured by accelerometry (ActiGraph), from baseline to 6 and 12 months. Participants will wear an accelerometer on their wrist during a 7 day period.

    Measured: Baseline, 6 months, 12 months

  5. Minutes of light-intensity physical activity: self-report

    Change in levels of light-intensity physical activity, as measured by a modified version of the Godin Leisure Time Exercise Questionnaire, from baseline to 6 and 12 months. Participants report frequency of light, moderate and vigorous exercise, and average duration (minutes) for light, moderate and vigorous exercise bouts in a typical week. Scores for light-intensity physical activity are scored as minutes/week.

    Measured: Baseline, 6 months, 12 months

  6. Minutes of moderate-to-vigorous intensity physical activity: objective

    Change in levels of moderate-to-vigorous intensity physical activity, as measured by accelerometry (ActiGraph), from baseline to 6 and 12 months. Participants will wear an accelerometer on their wrist during a 7 day period.

    Measured: Baseline, 6 months, 12 months

  7. Minutes of moderate-to-vigorous intensity physical activity: self-report

    Change in levels of moderate-to-vigorous intensity physical activity, as measured by a modified version of the Godin Leisure Time Exercise Questionnaire, from baseline to 6 and 12 months. Participants report frequency of light, moderate and vigorous exercise, and average duration (minutes) for light, moderate and vigorous exercise bouts in a typical week. Scores for moderate and vigorous exercise are combined to compute moderate-to-vigorous intensity minutes/week.

    Measured: Baseline, 6 months, 12 months

  8. Steps per day: objective

    Change in steps per day, as measured by by accelerometry (ActiGraph), from baseline to 6 and 12 months. Participants will wear an accelerometer on their wrist during a 7 day period. Steps will be averaged over a minimum of 3 out of 7 days to calculate average daily step count.

    Measured: Baseline, 6 months, 12 months

  9. Steps per day: Fitbit

    Change in steps per day, as measured by by Fitbit, from baseline to 6 and 12 months. Participants will wear a Fitbit on their wrist during a 7 day period. Steps will be averaged over a minimum of 3 out of 7 days to calculate average daily step count.

    Measured: Baseline, 6 months, 12 months

  10. Sedentary behavior

    Change in sedentary behavior, as measured by self-report Sedentary Behavior Questionnaire, from baseline to 6 and 12 months. Participants will be asked to indicate the number of hours they spend on a typical weekday and typical weekend day doing a variety of sedentary activities. Responses range from 1 (none) to 9 (6 or more hours). To obtain weekly estimates of sedentary behavior, weekday hours are multiplied by 5 and weekend hours are multiplied by 2 and summed for total hours/week.

    Measured: Baseline, 6 months, 12 months

  11. Weight

    Change in weight, as measured objectively with digital scales, from baseline to 6 and 12 months.

    Measured: Baseline, 6 months, 12 months

  12. Health-related quality of life: Medical Outcomes Study 36-Item Short Form (SF-36)

    Change in health-related quality of life, as measured using the Medical Outcomes Study 36-Item Short Form (SF-36), from baseline to 3, 6, and 12 months. The SF-36 asks respondents to rate their health and abilities to do their usual tasks. The SF-36 uses a variety of questions and response options and includes 8 subscales (physical functioning, role limitations due to physical health, role limitations due to emotional health, energy/fatigue, emotional well-being, social functioning, pain, and general health). Responses are coded on a scale of 0 to 100 where 0 is the worst possible health and 100 is the most favorable health score. The coded responses will be summed to yield a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score.

    Measured: Baseline, 3 months, 6 months, 12 months

  13. Health-related quality of life: Functional Assessment of Cancer Therapy-General (FACT-G)

    Change in health-related quality of life, as measured using the Functional Assessment of Cancer Therapy-General (FACT-G) survey, from baseline to 3, 6, and 12 months. The FACT-G is a 27-item measure specific to cancer patients to provide insight into cancer specific factors in four dimensions (physical, social/family, emotional, functional well-being). Participants will respond to a list of statements that tend to impact people with cancer by indicating how much they are impacted on a scale of 0 (not at all) to 4 (very much). Scores for negatively worded statements are reversed so that higher scores indicate positive health. Scores from the four dimensions can be summed to create a total score. Total possible scores range from 0 to 108, with higher scores indicating increased well being.

    Measured: Baseline, 3 months, 6 months, 12 months

  14. Behavioral capability

    Change in behavioral capability, as measured by self-report questionnaire, from baseline to 3, 6, and 12 months. Participants will be asked to rate how much they agree with six different statements. Responses range from 1 (strongly disagree) to 6 (strongly agree) and are averaged. Higher scores represent higher behavioral capability.

    Measured: Baseline, 3 months, 6 months, 12 months

  15. Self-efficacy for exercise

    Change in self-efficacy for exercise, as measured by the Self-Efficacy and Exercise Habits Survey, from baseline to 3, 6, and 12 months. Responses for two subscales (Sticking to it, Making time for exercise) are averaged to yield a score from 1 to 5, with higher values representing higher self-efficacy for exercise.

    Measured: Baseline, 3 months, 6 months, 12 months

  16. Self-regulation

    Change in self-regulation, as measured using by self-report questionnaire, from baseline to 3, 6, and 12 months. Responses to two subscales (Exercise goal-setting, Exercise planning and scheduling), ranging from 1 (does not describe) to 5 (describes completely), are averaged to yield two subscales. Higher subscale scores represent higher self-regulation.

    Measured: Baseline, 3 months, 6 months, 12 months

  17. Social support for exercise

    Change in social support for exercise, as measured by the Social Support for Exercise Survey, from baseline to 3, 6, and 12 months. Responses for three factors (Family participation, Friend participation, Friends on social networking sites participation), ranging from 1 to 5, are summed, with higher values representing higher social support for exercise.

    Measured: Baseline, 3 months, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2018
  2. Study start23 Aug 2018
  3. Primary completion29 Jan 2021
  4. Study completion29 Jan 2021

Resources

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
Randomised
Intervention model
Parallel groups
Model description
After completing informed consent, 7-day PA assessment, weight measurement, and baseline questionnaires, participants will be randomly assigned with equal probability to 1 of 2 treatment groups: 1) self-help or 2) intervention. Future treatment assignments will be concealed from study staff who are recruiting and enrolling participants.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03569605
Sponsor's protocol ID
LCCC1707
Other IDs
R01CA204965
Acronym
IMPACT
Status last verified
Mar 2021
First submitted
21 May 2018
Last updated
1 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Choi SM, Willis EA, Smitherman AB, Martin SL, Tate DF, Valle CG. Disentangling Positive Affect Heterogeneity in a Digital Physical Activity Intervention for Young Adult Cancer Survivors: A Group-Based Multi-Trajectory Modeling Approach. Psychooncology. 2026 May;35(5):e70484. doi: 10.1002/pon.70484.

    PubMed 42133893
  • Valle CG, Heiling HM, Deal AM, Diamond MA, Hales DP, Nezami BT, Rini CM, Pinto BM, LaRose JG, Tate DF. Examining sociodemographic and health-related characteristics as moderators of an mHealth intervention on physical activity outcomes in young adult cancer survivors. J Cancer Surviv. 2025 Oct;19(5):1611-1622. doi: 10.1007/s11764-024-01577-4. Epub 2024 Apr 12.

    PubMed 38607515
  • Valle CG, Diamond MA, Heiling HM, Deal AM, Hales DP, Nezami BT, Pinto BM, LaRose JG, Rini CM, Tate DF. Effect of an mHealth intervention on physical activity outcomes among young adult cancer survivors: The IMPACT randomized controlled trial. Cancer. 2023 Feb 1;129(3):461-472. doi: 10.1002/cncr.34556. Epub 2022 Nov 29.

    PubMed 36444676
  • Valle CG, Camp LN, Diamond M, Nezami BT, LaRose JG, Pinto BM, Tate DF. Recruitment of young adult cancer survivors into a randomized controlled trial of an mHealth physical activity intervention. Trials. 2022 Apr 4;23(1):254. doi: 10.1186/s13063-022-06148-5.

    PubMed 35379294
  • Valle CG, Pinto BM, LaRose JG, Diamond M, Horrell LN, Nezami BT, Hatley KE, Coffman EM, Polzien K, Hales DP, Deal AM, Rini CM, Rosenstein DL, Tate DF. Promoting physical activity in young adult cancer survivors using mHealth and adaptive tailored feedback strategies: Design of the Improving Physical Activity after Cancer Treatment (IMPACT) randomized controlled trial. Contemp Clin Trials. 2021 Apr;103:106293. doi: 10.1016/j.cct.2021.106293. Epub 2021 Jan 27.

    PubMed 33515784

Questions about this trial

What is this clinical trial studying?

A study testing Self-help and Intervention in people with Physical Activity and Neoplasms, run by UNC Lineberger Comprehensive Cancer Center 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 12 inclusion and 9 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 1 Apr 2021. 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?

Minutes of total physical activity at 6 months: objective (time frame: Baseline, 6 months). 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 NCT03569605, which also lists 5 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 1 Apr 2021.

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